Drugs

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(A) [ 2007-2008 ]

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

1

ABILIFY 10mg

Aripiprazole 10mg

Tablets

schizophrenia.

Bristol Myers Squibb

Modern Pharmaceutical Co.

CD (A)

2

ABILIFY 15mg

Aripiprazole 15mg

Tablets

schizophrenia.

Bristol Myers Squibb

Modern Pharmaceutical Co.

CD (A)

3

ABILIFY 20mg

Aripiprazole 20mg

Tablets

schizophrenia.

Bristol Myers Squibb

4

ABILIFY 30mg

Aripiprazole 30mg

Tablets

schizophrenia.

Bristol Myers Squibb

5

Addnok 2mg

Buprenorphine 2 mg / 1 Tablet

sublingual tablet

Opoid analgesic

Rusan Pharma Ltd

6

ADUMBRAN

Oxazepam 10 mg

Tablets

Anti anxiety

CLAG LTD.

7

ANEXATE 0.5mg/5ml

Flumazenil 0.1mg/ml

Injection

Antidote for benzodiazepines

Page 1 of 49

Modern Pharmaceutical Co. Modern Pharmaceutical Co. Al INMA Drug store and medical Gulf Drug Est.

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

CD (A)

CD (A)

CD (A)

CD (A)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(A) [ 2007-2008 ]

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

ANEXATE 1mg/10ml

Flumazenil 0.1mg/ml

Injection

Antidote for benzodiazepines

9

ARTHROTEC 50

Misoprostol 0.2mg Diclofenac sodium 50mg

Tablets

NSAID'S

Searle Pharm.

Al Baker Trading

CD (A)

10

ATIVAN 1

Lorazepam 1mg

Tablets

Anxiolytic

Wyeth-Pharma GmbH

Modern Pharmaceutical Co.

CD (A)

ANAESTHESIA

Hameln Pharmaceuticals GmbH[Hameln;GER MANY]

Gulf Drug Est.

CD (A)

Gulf Drug Est.

CD (A)

City Pharmacy

CD (A)

Alphamed

CD (A)

8

11

Atracurium-hameln Atracurium besilate 10mg/ml (25mg/2.5ml) (25mg/2.5ml) Injection

12

Atracurium-hameln 10mg/ml (50mg/5ml) Injection

Atracurium besilate (50mg/5ml)

Injection

ANAESTHESIA

13

Atracurium-besylate

Atracurium Dibesylate 10mg/1 ml

Injection

ANAESTHESIA

14

BARNETIL 200mg/2ml

Sultopride 200mg/2ml

Injection

Schizophrenia

Injection

Page 2 of 49

COMPANY

AGENT

Hoffman La ROCHE Al Razi Pharmacy

Hameln Pharmaceuticals GmbH[Hameln;GER MANY] ABBOTT LABORATORIES[Ka nsas;USA] Delagrange Lab.

DISP. CD (A)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(A) [ 2007-2008 ]

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

15

BARNETIL 400

Sultopride 400mg

Tablets

Schizophrenia

Delagrange Lab.

Alphamed

CD (A)

16

BUCCASTEM 3mg

Prochlorperazine Maleate 3mg

Tablets

Nausia and Vomiting

Reckitt Benckiser

City Pharmacy

CD (A)

17

CLOPIXOL 2

Zuclopenhtixol diHCL 2mg

Tablets

Antipsychotic, Neuroleptic

Lundbeck

18

CLOPIXOL 25

Zuclopenhtixol diHCL 25mg

Tablets

Antipsychotic, Neuroleptic

Lundbeck

19

CLOPIXOL -Acuphase 100mg

Zuclopenhtixol acetate 100mg/2ml

Injection

Antipsychotic, Neuroleptic

Lundbeck

20

CLOPIXOL Depot 200

Zuclopenhtixol decanoate 200mg/ml

Injection

Antipsychotic, Neuroleptic

Lundbeck

21

CLOPIXOL Depot 500

Zuclopenhtixol acetate 500mg/ml

Injection

Antipsychotic, Neuroleptic

Lundbeck

22

CLOPIXOL10

Zuclopenhtixol diHCL 10mg

Tablets

Antipsychotic, Neuroleptic

Lundbeck

Page 3 of 49

Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co.

CD (A)

CD (A)

CD (A)

CD (A)

CD (A)

CD (A)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS TRADE NAME

GENERIC NAME

FORM

INDICATIONS

CD(A) [ 2007-2008 ]

COMPANY

AGENT

DISP. CD (A)

Injection

Antipsychotic, Neuroleptic

Lundbeck

Modern Pharmaceutical Co.

Capsules

Antitussive

Heinrich Mack

Pharmatrade

CD (A)

Syrup

Antitussive

Heinrich Mack

Pharmatrade

CD (A)

Tablets

Antitussive, Expectorant

Heinrich Mack

Pharmatrade

CD (A)

Misoprostol 200mcg

Tablets

Ulcer healing drug

Searle Pharm.

Al Baker Trading

CD (A)

DEANXIT

Flupentixol diHCL 0.5mg, Melitracene HCL 10mg

Tablets

Antipsychotic

Lundbeck

Modern Pharmaceutical Co.

CD (A)

29

DEHYDROBENZPERIDOL

Droperidol 2.5mg/ml

Injection

Antipsychotic, Neuroleptic

Janssen Pharm.

City Pharmacy

CD (A)

30

DEMETRIN 10

Prazepam 10mg

Tablets

Anxiolytic

Parke-Davis

New Medical Center

CD (A)

31

DHC CONTINUS

Tablets

Analgesic

Bard Pharm.

City Pharmacy

CD (A)

32

DIALAG microclysma

Rectal solution

Anxiolytic

Lagap SA

New Medical Center

CD (A)

23

CLOPIXOL-Acuphase 50mg

24

CODIPRONT

25

CODIPRONT

26

CODIPRONT Cum Exp.

27

CYTOTEC

28

Zuclopenhtixol acetate 50mg/ml Codeine 30mg, Phenyltoloxamine 10mg Codeine 11.1mg , Phenyltoloxamine 3.7mg/5ml Codeine 30mg , Phenyltoloxamine

Dihydrocodeine tartrate 60mg Diazepam 5mg/2.5ml

Page 4 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS TRADE NAME

GENERIC NAME

FORM

33

DIALAG microclysma

Diazepam 10mg/2.5ml

Rectal solution

34

DIAPAM 10

Diazepam 10mg

35

DIAPAM 2

36

COMPANY

AGENT

DISP.

Anxiolytic

Lagap SA

New Medical Center

CD (A)

Tablets

Anxiolytic

Orion Pharm.Co.

Al Hayat Pharm.

CD (A)

Diazepam 2mg

Tablets T bl t

Anxiolytic A i l ti

Orion Pharm.Co. O i Ph C

Al Hayat H t Pharm. Ph

CD (A)

DIAPAM 5

Diazepam 5mg

Tablets

Anxiolytic

Orion Pharm.Co.

Al Hayat Pharm.

CD (A)

37 38

DIAZEPAM 2 DIAZEPAM 5

Tablets Tablets

Anxiolytic Anxiolytic

Julphar Julphar

Julphar Julphar

CD (A) CD (A)

39

DICTON retard 30

Diazepam 2mg Diazepam 5mg Codeine 11mg , Carbinoxamine 1.5mg/5ml

Dolorgiet

Arabian Ethicals

CD (A)

40

DIPRIVAN 1% w/v

Propofol 1.00% w/v

I.V. Infusion

41

DIPRIVAN 2% w/v

Propofol 20mg/1ml

I.V. Infusion

Anaesthetic

Astra Zeneca

42

DOGMATIL 100

Sulpiride 100 mg/2ml

Injection

Schizophrenia

Synthelabo

Alphamed

CD (A)

Solution

Schizophrenia

Synthelabo

Alphamed

CD (A)

Capsules Tablets

Schizophrenia Schizophrenia

Synthelabo Synthelabo

Alphamed Alphamed

CD (A) CD (A)

43 44 45

DOGMATIL 25mg/5ml Sulpiride 25mg/5ml DOGMATIL 50 DOGMATIL Forte

Sulpiride 50 mg Sulpiride 200 mg

Syrup

INDICATIONS

CD(A) [ 2007-2008 ]

Antihistaminic, Antitussive Anaesthetic

Page 5 of 49

Astra Zeneca

Modern Pharmaceutical Co. Modern Pharmaceutical Co.

REMARKS

(Hospital use) CD (A)

(Hospital use) CD (A)

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(A) [ 2007-2008 ]

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

46

DORMICUM 15

Midazolam 15mg

Tablets

Anxiolytic

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

47

DORMICUM 15mg/3ml

Midazolam 15mg/3ml

Injection

Anxiolytic

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

48

DORMICUM 5mg/ml 5 / l

Midazolam 5mg/ml

Injection I j ti

Anxiolytic A i l ti

Hoffman La H ff L ROCHE Al Razi R i Pharmacy Ph

CD (A)

49

DORMICUM 7.5mg

Midazolam 7.5mg

Tablets

Anxiolytic

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

50

DORSILON

Mephenoxalone 200mg,Paracetamol 450mg

Tablets

Muscle relaxant

Syntex Pharma A.G

51

FLUANXOL 0.25

Flupenthixol 0.25mg

Tablets

Antidepressant

Lundbeck

52

FLUANXOL 0.5

Flupenthixol 0.5mg

Tablets

Antidepressant

Lundbeck

53

FLUANXOL 1

Flupenthixol 1mg

Tablets

Antidepressant

Lundbeck

54

FLUANXOL 3

Flupenthixol 3mg

Tablets

Antidepressant

Lundbeck

55

FLUANXOL Depot

Flupenthixol 20mg/ml

Injection

Antidepressant

Lundbeck

Page 6 of 49

COMPANY

AGENT

Modern Pharmacy Co. Modern Pharmacy Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co.

DISP.

CD (A) CD (A) CD (A)

CD (A)

CD (A)

CD (A)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS FORM

INDICATIONS

CD(A) [ 2007-2008 ]

TRADE NAME

GENERIC NAME

56

FLUANXOL Depot

Flupentixol decanoate

Injection

Antidepressant

Lundbeck

57

FRISIUM 10

Clobazam 10 mg

Tablets

Anxiolytic

Hoechst

58

FRISIUM 20

Clobazam 20 mg

Tablets

Anxiolytic

Hoechst

59

GARDINAL SODIUM

Phenobarbitone sodium 200mg/ml

Injection

Antiepileptic

May&Baker RhonePoulenc

60

GENPRID 50

Sulpiride 50 mg

Tablets

Schizophrenia

Riyadh Pharma

61

GENPRID 200

Sulpiride 200 mg

Capsules

Schizophrenia

Riyadh Pharma

62

HALDOL 0.5

Haloperidol 0.5mg

Tablets

63

HALDOL 2mg/ml

Haloperidol 2mg/ml

Drops

64

HALDOL 5

Haloperidol 5mg

Tablets

65

HALDOL 5mg/ml

Haloperidol 5mg/ml

Injection

66

HALDOL Decanoas

Haloperidol 50mg/ml

Injection

Antipsychotic, Neuroleptic Antipsychotic, Neuroleptic Antipsychotic, Neuroleptic Antipsychotic, Neuroleptic Antipsychotic, Neuroleptic

Page 7 of 49

COMPANY

AGENT Modern Pharmaceutical Al Ittihad Pharmacy Al Ittihad Pharmacy Pharmatrade Modern Pharmaceutical Co. Modern Pharmaceutical Co.

DISP. CD (A) CD (A) CD (A) CD (A) CD (A)

CD (A)

Janssen Pharm.

City Pharmacy

CD (A)

Janssen Pharm.

City Pharmacy

CD (A)

Janssen Pharm.

City Pharmacy

CD (A)

Janssen Pharm.

City Pharmacy

CD (A)

Janssen Pharm.

City Pharmacy

CD (A)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS TRADE NAME

GENERIC NAME Haloperidol 100mg/ml Chlormethiazole 300mg, Miglyol(812) 125mg

CD(A) [ 2007-2008 ]

FORM

INDICATIONS

COMPANY

AGENT

DISP.

Injection

Antipsychotic, Neuroleptic

Janssen Pharm.

City Pharmacy

CD (A)

Capsules

Hypnotic,Status Epilepticus

Astra Zeneca

Alphamed

CD (A)

67

HALDOL Decanoas

68

HEMINEVRIN

69

HIKMA MIDAZOLAM 15mg/3ml

Midazolam HCL15mg/3ml

Injection

Anxiolytic

Al Hikma Pharm.

Al Hayat Pharm.

CD (A)

70

INTRAVAL

Thiopentone Sodium 0.5g/1vial

Injection

Anaesthetic

May & Baker Rhone-Poulenc

Pharmatrade

CD (A)

71

KETALAR 10

Ketamine HCL 10mg/ml

Injection

Parke-Davis

New Medical Center

CD (A)

72

KETALAR 50

Ketamine HCL 50mg/ml

Injection

Parke-Davis

New Medical Center

CD (A)

73

LARGACTIL

Pharmatrade

CD (A)

74

LARGACTIL 10

Pharmatrade

CD (A)

75

LARGACTIL 100

Pharmatrade

CD (A)

76

LARGACTIL 25

Pharmatrade

CD (A)

Chlorpromazine HCL 25mg/5ml Chlorpromazine HCL 10mg Chlorpromazine HCL 100mg Chlorpromazine HCL 25mg

Syrup Tablets Tablets Tablets

Induction, maintenance of anesthesia Induction, maintenance of anesthesia Neuroleptic, Antipsychotic Neuroleptic, Antipsychotic Neuroleptic, Antipsychotic Neuroleptic, Antipsychotic

Page 8 of 49

May&Baker RhonePoulenc May&Baker RhonePoulenc May&Baker RhonePoulenc May&Baker RhonePoulenc

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS TRADE NAME

GENERIC NAME Chlorpromazine HCL 25mg/ml Chlorpromazine HCL 50mg p Chlorpromazine HCL 50mg/2ml Chlorpromazine HCL 100mg

FORM

INDICATIONS

COMPANY

Neuroleptic, Antipsychotic Neuroleptic, Antipsychotic p Neuroleptic, Antipsychotic Neuroleptic, Antipsychotic

May&Baker RhonePoulenc May&Baker RhonePoulenc y May&Baker RhonePoulenc May&Baker RhonePoulenc

AGENT

DISP.

Pharmatrade

CD (A)

Pharmatrade

CD (A)

Pharmatrade Ph t d

CD (A)

Pharmatrade

CD (A)

77

LARGACTIL 25mg/ml

78

LARGACTIL 50

79

LARGACTIL 50mg/2ml 50 /2 l

80

LARGACTIL100

81

LEXOTANIL 1.5

Bromazepam 1.5 mg

Tablets

Anxiolytic

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

82

LEXOTANIL 3

Bromazepam 3 mg

Tablets

Anxiolytic

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

83

LEXOTANIL 6

Bromazepam 6 mg

Tablets

Anxiolytic

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

Capsules

Antidepressant+ Anxiolytic

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

84

LIMBITROL

85

MELLERIL 0.5%

86

MELLERIL 10mg

87

MELLERIL25mg

88

MELLERIL 50mg

Amitriptyline 12.5 mg, Chlordiazepoxide 5 mg Thioridazine HCl 0.5% Thioridazine HCl 10mg/Tablet Thioridazine HCl 25mg/Tablet Thioridazine HCl 50mg/Tablet

Injection

CD(A) [ 2007-2008 ]

Tablets Injection I j ti Suppo.

Suspension Tablets Tablets Tablets

Antipsycotic & Anxiolytic Antipsycotic & Anxiolytic Antipsycotic & Anxiolytic Antipsycotic & Anxiolytic

Page 9 of 49

Novartis Pharma AG. Novartis Pharma AG. Novartis Pharma AG. Novartis Pharma AG.

City Pharmacy

CD (A)

City Pharmacy

CD (A)

City Pharmacy

CD (A)

City Pharmacy

CD (A)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(A) [ 2007-2008 ]

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

89

MELLERIL 100mg

Thioridazine HCl 100mg/Tablet

Tablets

Antipsycotic & Anxiolytic

Novartis Pharma AG.

City Pharmacy

CD (A)

90

NEOTIGASON 10

Acitretin 10 mg

Capsules

Psoriasis

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

91

NEOTIGASON 25

Acitretin 25 mg

Capsules

Psoriasis

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

92

NOBRIUM 10

Medazepam 10mg

Capsules

Anxiolytic

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

93

NOBRIUM 5

Medazepam 5mg

Capsules

Anxiolytic

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

94

NOCTRAN 10

Clorazepate dipotassium 10mg, Acepromazine maleate 1.016mg, Aceprometazine maleate 10.16mg

Tablets

Anxiolytic

Sanofi-Clin-MidyLabaz

City Pharmacy

CD (A)

95

NUBAIN 10mg/ml

Injection

Analgesic

Dupont Pharm.

City Pharmacy

CD (A)

96

NUBAIN 20mg/ml

Injection

Analgesic

Dupont Pharm.

City Pharmacy

CD (A)

97 98

ORAP ORAP Forte

Tablets Tablets

Antipsychotic Antipsychotic

Janssen Pharm. Janssen Pharm.

CD (A) CD (A)

99

PROLIXIN 25mg/ml

Injection

Antipsychotic, Neuroleptic

Bristol-Myers Squibb

City Pharmacy City Pharmacy Modern Pharmaceutical Co.

Nalbuphine HCL 10mg/ml Nalbuphine HCL 20mg/ml Pimozide 1mg Pimozide 4mg Fluphenazine decanoate 25mg/ml

Page 10 of 49

CD (A)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS TRADE NAME

GENERIC NAME

FORM

CD(A) [ 2007-2008 ]

INDICATIONS

COMPANY

AGENT

DISP.

Modern Pharmaceutical Co.

CD (A)

100

PROPESS

Prostaglandin E2 10mg/pessary

Vaginal Pessaries

Prostaglandins and Oxytocics

Controlled Therapeutics (Scotland) ltd.

101

Provive 1%

p g Propofol 10mg/ml

Emulsion for Infusion

General Anaesthesia

CLARIS LIFESCIENCES LIMITED

New Medical Centre

CD (A)

102

RISPERDAL 1

Tablets

Antipsychotic

Janssen Pharm.

City Pharmacy

CD (A)

103

RISPERDAL 1mg/ml

Risperidone 1mg Risperidone 1mg/1ml Risperidone 2mg Risperidone 3mg Risperidone 4mg Risperidone

Oral Solution

Antipsychotic

Janssen Pharm.

City Pharmacy

CD (A)

Tablets Tablets Tablets Inj/ Suspension

Antipsychotic Antipsychotic Antipsychotic

Janssen Pharm. Janssen Pharm. Janssen Pharm. Janssen-Cilag AG

City Pharmacy City Pharmacy City Pharmacy

CD (A) CD (A) CD (A)

104 105 106 107

RISPERDAL 2 RISPERDAL 3 RISPERDAL 4 Risperidal Consta 25mg

CD (A)

Schizophrenia City Pharmacy

108 109

Risperidal Consta 37.5 mg Risperidal Consta 50 mg

Risperidone Risperidone

Inj/ Suspension Inj/ Suspension

Schizophrenia Schizophrenia

Janssen-Cilag AG City Pharmacy Janssen-Cilag AG City Pharmacy

CD (A) CD (A)

110

RIVOTRIL 0.25%

Clonazepam 0.25%

Drops

Antiepileptic,Sedative Hoffman La ROCHE Al Razi Pharmacy

CD (A)

111

RIVOTRIL 0.5

Clonazepam 0.5 mg

Tablets

Antiepileptic,Sedative Hoffman La ROCHE Al Razi Pharmacy

CD (A)

Page 11 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS INDICATIONS

CD(A) [ 2007-2008 ]

TRADE NAME

GENERIC NAME

FORM

112

RIVOTRIL 1mg/ml

Clonazepam 1mg/ml

Injection

Antiepileptic,Sedative Hoffman La ROCHE Al Razi Pharmacy

CD (A)

113

RIVOTRIL 2

Clonazepam 2mg

Tablets

Antiepileptic,Sedative Hoffman La ROCHE Al Razi Pharmacy

CD (A)

114

SERENACE 0.5 05

Haloperidol 0.5mg 0 5mg

Tablets T bl t

115

SERENACE 1.5

Haloperidol 1.5mg

Tablets

116

SERENACE 10

Haloperidol 10mg

Tablets

117

SERENACE 5

Haloperidol 5mg

Tablets

118

SEROQUEL 100 mg

Quetiapine 100 mg

Tablets

Schizophrenia

Astra Zeneca

119

SEROQUEL 200 mg

Quetiapine 200 mg

Tablets

Schizophrenia

Astra Zeneca

120

SEROQUEL 300 mg

Quetiapine 300 mg

Tablets

Schizophrenia

Astra Zeneca

121

SEROQUEL 25 mg

Quetiapine 25 mg

Tablets

Schizophrenia

Astra Zeneca

p y Antipsychotic, Neuroleptic Antipsychotic, Neuroleptic Antipsychotic, Neuroleptic Antipsychotic, Neuroleptic

Page 12 of 49

COMPANY

AGENT

DISP.

Searle S l Pharm. Ph

Al Baker B k Trading T di

CD (A)

Searle Pharm.

Al Baker Trading

CD (A)

Searle Pharm.

Al Baker Trading

CD (A)

Searle Pharm.

Al Baker Trading

CD (A)

Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co.

CD (A)

CD (A)

CD (A)

CD (A)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(A) [ 2007-2008 ]

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

122

SEROQUEL Patient Starter Pack

Quetiapine 100 mg/tab. (2 tablets), Quetiapine 25 mg/tab. (6 tablets)

Tablets

Schizophrenia

Astra Zeneca

Modern Pharmaceutical Co.

CD (A)

123

SONATA 10mg

Zaleplon 10mg/1capsule

Capsules

Hypnotic,Anxiolytic

Wyeth Medica Ireland

124

SONATA 5mg

Zaleplon 5mg/1capsule

Capsules

Hypnotic,Anxiolytic

Wyeth Medica Ireland

125

STADOL 1mg/ml

Butorphanol tartrate 1mg/ml

Injection

Opoid analgesic

Bristol laboratories corp.

126

STADOL 2mg/ml

Butorphanol tartrate 2mg/ml

Injection

Opoid analgesic

Bristol laboratories corp.

127

STADOL 4mg/2ml

Butorphanol tartrate 4mg/2ml

Injection

Opoid analgesic

Bristol laboratories corp.

128

STELAZINE 1

Trifluoperazine 1mg

Tablets

Antipsychotic

129

STELAZINE 10

Capsules

Antipsychotic

130

STELAZINE 15

Spansule

Antipsychotic

Trifluoperazine 10mg Trifluoperazine 15mg

Page 13 of 49

Smith Kline Beecham Smith Kline Beecham Smith Kline Beecham

Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co.

CD (A)

CD (A)

CD (A)

CD (A)

CD (A)

Gulf Drug Est.

CD (A)

Gulf Drug Est.

CD (A)

Gulf Drug Est.

CD (A)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS TRADE NAME

GENERIC NAME

FORM

INDICATIONS

131

STELAZINE 2

Trifluoperazine 2mg

Spansule

Antipsychotic

132

STELAZINE 5

Trifluoperazine 5mg

Tablets

Antipsychotic

133

STEMETIL

134

STEMETIL

135

STEMETIL

136

STEMETIL

137

STEMETIL

138

STESOLID

Diazepam 0.4mg/ml

Syrup

139

STESOLID

Diazepam 2mg

Tablets

140

STESOLID

Diazepam 5mg

Tablets

141

STESOLID

Diazepam 5mg/ml

Injection

142

STESOLID

Diazepam 5mg/2.5ml

Rectal solution

p Prochlorperazine maleate 0.1%w/v Prochlorperazine maleate 25mg Prochlorperazine maleate 5mg Prochlorperazine maleate12.5mg/ml Prochlorperazine maleate 25mg/2ml

Syrup S Tablets Tablets Injection Injection

g Nausea,Vomiting, Vertigo Nausea,Vomiting, Vertigo Nausea,Vomiting, Vertigo Nausea,Vomiting, Vertigo Nausea,Vomiting, Vertigo Anxiolytic, Anticonvulsant Anxiolytic, Anticonvulsant Anxiolytic, Anticonvulsant Anxiolytic, Anticonvulsant Anxiolytic, Anticonvulsant

Page 14 of 49

CD(A) [ 2007-2008 ]

COMPANY

AGENT

DISP.

Gulf Drug Est.

CD (A)

Gulf Drug Est.

CD (A)

Pharmatrade Ph t d

CD (A)

Pharmatrade

CD (A)

Pharmatrade

CD (A)

Pharmatrade

CD (A)

Pharmatrade

CD (A)

Alpharma ApS

Gulf Drug Est.

CD (A)

Alpharma ApS

Gulf Drug Est.

CD (A)

Alpharma ApS

Gulf Drug Est.

CD (A)

Alpharma ApS

Gulf Drug Est.

CD (A)

Alpharma ApS

Gulf Drug Est.

CD (A)

Smith Kline Beecham Smith Kline Beecham y May&Baker RhonePoulenc May&Baker RhonePoulenc May&Baker RhonePoulenc May&Baker RhonePoulenc May&Baker RhonePoulenc

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

Diazepam 10mg/2.5ml Zolpidem Tartrate 10mg/1 tab.

Rectal solution

Anxiolytic, Anticonvulsant

Alpharma ApS

Gulf Drug Est.

CD (A)

Tablets

Hypnotics

Synthelabo

Alphamed (AUH) Ltd.

CD (A)

Al Hikma Pharm.

Al Hayat Pharm.

CD (A)

Al Hikma Pharm.

Al Hayat Pharm.

CD (A)

143

STESOLID

144

STILNOX 10mg

145

TEKAM 10

Ketamine HCL K t i 10mg/ml

Injection

146

TEKAM 50

Ketamine HCL 50mg/ml

Injection

147

TEMGESIC 0.3mg/ml

Buprenorphine HCL

0.3 mg/ml Buprenorphine HCL 148 TEMGESIC 0.6mg/2ml 0.6mg/2ml Buprenorphine HCL 149 TEMGESIC Sublingual 0.2 mg 150

TIAPRIDAL 100

Tiapride 100mg

151 TIAPRIDAL 100mg/2ml Tiapride 100mg/2ml 152

TRAMAL 100mg

CD(A) [ 2007-2008 ]

Tramadol 100mg

Induction,, maintenance of anesthesia Induction, maintenance of anesthesia

Injection

Opioid Analgesic

Reckitt Benckiser

City Pharmacy

CD (A)

Injection

Opioid Analgesic

Reckitt Benckiser

City Pharmacy

CD (A)

Tablets

Opioid Analgesic

Reckitt Benckiser

City Pharmacy

CD (A)

Tablets

Schizophrenia

Synthelabo

Alphamed

CD (A)

Injection

Schizophrenia

Synthelabo

Alphamed

CD (A)

Supp.

Potent analgesic

Grunenthal Gmbh

Modern Pharmaceutical Co.

CD (A)

Page 15 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS TRADE NAME

GENERIC NAME

FORM

INDICATIONS

CD(A) [ 2007-2008 ]

COMPANY

153

TRAMAL 100mg/2ml

Tramadol 100mg/2ml

Injection

Potent analgesic

Grunenthal Gmbh

154

g/ TRAMAL 100mg/ml

Tramadol 100mg/ml

p Drops

g Potent analgesic

Grunenthal Gmbh

155

TRAMAL 50mg

Tramadol 50mg

Capsules

Potent analgesic

Grunenthal Gmbh

156

TRAMAL Rapid 50mg

Tramadol 50mg

Tablets

Potent analgesic

Grunenthal Gmbh

157

TRAMAL 50mg/ml

Tramadol 50mg/ml

Injection

Potent analgesic

Grunenthal Gmbh

158

TRAMAL Retard 100

Tramadol 100mg

Tablets

Potent analgesic

Grunenthal Gmbh

159

TRAMAL Retard 150

Tramadol 150mg

Tablets

Potent analgesic

Grunenthal Gmbh

160

TRAMAL Retard 200

Tramadol 200mg

Tablets

Potent analgesic

Grunenthal Gmbh

Page 16 of 49

AGENT Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co.

DISP. CD (A)

CD (A)

CD (A)

CD (A)

CD (A)

CD (A)

CD (A)

CD (A)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS TRADE NAME TRAMUNDIN RETARD 161 100 mg TRAMUNDIN RETARD 162 150 mg TRAMUNDIN RETARD 163 200 mg

GENERIC NAME

FORM

INDICATIONS

Tramadol 100mg

Tablets

Potent analgesic

Tramadol 150mg

Tablets

Potent analgesic

Tramadol 200mg

Tablets T bl t

Potent P t t analgesic l i

Capsules

Anxiolytic

Capsules

Anxiolytic

Clorazepate dipotassium 10mg Clorazepate dipotassium 5mg

164

TRANXENE 10

165

TRANXENE 5

166

VALIUM

Diazepam 2mg/5ml

Syrup

167

VALIUM

Diazepam 10mg/2ml

Injection

168

VALIUM 10

Diazepam 10mg

Tablets

169

VALIUM 2

Diazepam 2mg

Tablets

170

VALIUM 5

Diazepam 5mg

Tablets

Anxiolytic, Anticonvulsant Anxiolytic, Anticonvulsant Anxiolytic, Anticonvulsant

CD(A) [ 2007-2008 ]

COMPANY Mundipharma GmbH Mundipharma GmbH p Mundipharma GmbH Sanofi-Clin-MidyLabaz Sanofi-Clin-MidyLabaz

AGENT

DISP.

City Pharmacy

CD (A)

City Pharmacy

CD (A)

City Cit Pharmacy Ph

CD (A)

City Pharmacy

CD (A)

City Pharmacy

CD (A)

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

Anxiolytic, Anticonvulsant

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

Anxiolytic, Anticonvulsant

Hoffman La ROCHE Al Razi Pharmacy

CD (A)

Page 17 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(A) [ 2007-2008 ]

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

171

XANAX 0.25

Alprazolam 0.25 mg

Tablets

Anxiolytic

Pharmacia NV

Modern Pharmaceutical Co.

CD (A)

172

XANAX 0.5

Alprazolam 0.5 mg

Tablets

Anxiolytic

Pharmacia NV

173

XANAX 1

Alprazolam 1 mg

Tablets

Anxiolytic

Pharmacia NV

174

Zaldiar

Tramadol 37.5

Tablets

Analgesic

GRUNENTHAL GMBH

ZELDOX 20mg/ml

Ziprasidone 20mg/ml Ziprasidone 20mg Ziprasidone 40mg Ziprasidone 60mg Ziprasidone 80mg

Inj/Powder

175 176 177 178

ZELDOX ZELDOX ZELDOX ZELDOX

20mg 40mg 60mg 80mg

Capsules Capsules Capsules Capsules

179

Schizophrenia Schizophrenia Schizophrenia Schizophrenia

Pfizer GmbH Pfizer Pfizer Pfizer Pfizer

GmbH GmbH GmbH GmbH

Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co. Al Al Al Al

Baker Baker Baker Baker

Trading Trading Trading Trading

ZYPREXA 10 mg ZYPREXA 10 mg

Olanzapine 10 mg Olanzapine 10 mg

182

ZYPREXA 5 mg

Olanzapine 5 mg

Tablets Injection Velotabs/orod ispersable

CD (A)

CD (A) CD (A) CD (A) CD (A) CD (A) CD (A)

Schizophrenia

180 181

CD (A)

Schizophrenia Schizophrenia

Eli Lilly &Co. Eli Lilly &Co.

Al Baker Trading Pharmatrade Pharmatrade

CD (A) CD (A)

Schizophrenia

Eli Lilly &Co.

Pharmatrade

CD (A)

Page 18 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS TRADE NAME

GENERIC NAME

183

ZYPREXA 10 mg

Olanzapine 10 mg

184 185

ZYPREXA 5 mg ZYPREXA 7.5 mg

Olanzapine 5 mg Olanzapine 7.5 mg

FORM Velotabs/orod ispersable Tablets Tablets

CD(A) [ 2007-2008 ]

INDICATIONS

COMPANY

AGENT

DISP.

Schizophrenia

Eli Lilly &Co.

Pharmatrade

CD (A)

Schizophrenia Schizophrenia

Eli Lilly &Co. Eli Lilly &Co.

Pharmatrade Pharmatrade

CD (A) CD (A)

Page 19 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No.

1

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

123 COLD Tablets

Codeine phosphate 8mg, Acetaminophen 325mg,Cafeine 30mg,Carbinoxamine maleate 3.06mg,Phenylephrine 3 06mg Phenylephrine 5mg

Tablets

Cold&Allergy

Algorithm S.A.L

City Pharmacy

CD (B)

Codeine Phosphate10mg, Triprolidine1.25mg, Pseudoephedrine 30mg/5ml

Linctus

Antihistaminic, Decongestant

Glaxo-Wellcome

Al Baker Trading

CD (B)

Dextromethorphan 10mg , Triprolidine1.25mg, Pseudoephedrine 30mg/5ml

Linctus

Antihistaminic, Decongestant

Glaxo-Wellcome

Al Baker Trading

CD (B)

2

ACTIFED compound linctus

3

ACTIFED DM

ACTIVELLE 4

5

Tablets Estradiol 1 mg & Norethisterone 0.5 mg

ADOL cold

Dextromethorphan HBr 15mg, Pseudoephedrine HCL 30mg, Paracetamol 325mg

Caplets

Hormone Replacement Therapy

Decongestant

Page 20 of 49

CD (B) Novo Nordisk A/S

City Pharmacy

Julphar

Julphar

CD (B)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

6

ADOL COLD HOT THERAPY

Paracetamol 650mg, Pseudoephedrine HCL 60.0 mg, Dextromethorphan HBr 30.0 mg

Sachets

Cold and Influenza

Julphar

Julphar

CD (B)

7

ADOL compound

Codeine phosphate 10mg, 10mg Paracetamol 150mg,Cafeine 50mg,Salicylamide 200mg

Tablets

Analgesic

Julphar

Julphar

CD (B)

8

AKINETON 2mg

Biperiden HCL 2mg

Tablets

Parkinsonism

Knoll AG

Al Baker Trading

CD (B)

9

AKINETON 5mg

Biperiden Lactate 5mg/ml

Injection

Parkinsonism

Knoll AG

Al Baker Trading

CD (B)

10

AKINETON RETARD 4mg

Biperiden HCL 4mg

Tablets

Parkinsonism

Knoll AG

Al Baker Trading

CD (B)

11

ALGAPHAN

Dextropropoxyphene HCL 25mg Paracetamol 300mg

Tablets

Analgesic

Boehringer Mannheim

Pharmatrade

CD (B)

12

ALGAPHAN

Propoxyphene HCL 75mg Chlorobutanol 10 mg/2ml

Injection

Analgesic

Boehringer Mannheim

Pharmatrade

CD (B)

13

ANAFRANIL 10

Clomipramine HCL 10 mg

Tablets

Antidepressant

Novartis Pharma

City Pharmacy

CD (B)

14

ANAFRANIL 25

Clomipramine HCL 25 mg

Tablets

Antidepressant

Novartis Pharma

City Pharmacy

CD (B)

15

ANAFRANIL S.R 75

Clomipramine HCL 75 mg

Tablets

Antidepressant

Novartis Pharma

City Pharmacy

CD (B)

Page 21 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

Capsules

Male sex hormones

Tablets

DISP.

Parkinsonism

Organon N.V./Holland Lederle Lab.

Modern Pharmaceutical Co. Pharmatrade

CD (B)

16

ANDRIOL 40mg

17

ARTANE 2

Testosterone undecanoate 40mg Benzhexol HCL 2 mg

18

ARTANE 5

Benzhexol HCL 5mg

Tablets

Parkinsonism

Lederle Lab.

Pharmatrade

CD (B)

19

ATHYMIL 30 mg

Mianserin 30 mg

Tablets

Antidepressant drugs*

Organon NV

Modern Pharmaceutical Co.

CD (B)

20

ATHYMIL 60 mg

Mianserin 60 mg

Tablets

Antidepressant drugs*

Organon NV

Modern Pharmaceutical Co.

CD (B)

21

AURIMEL

Carbinoxamine maleate 2mg , Dextromethorphan HBr 5mg , Phenylephrine HCL 5mg , Sodium citrate 325 mg/5ml

Syrup

Antihistaminic, decongestant, antitussive

Algorithm S.A.L

City Pharmacy

CD (B)

22

AURORIX 100

Moclobemide 100mg

Tablets

Antidepressant

Hoffman La ROCHE

Al Razi Pharmacy

CD (B)

23

AURORIX 150

Moclobemide 150mg

Tablets

Antidepressant

Hoffman La ROCHE

Al Razi Pharmacy

CD (B)

Page 22 of 49

CD (B)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

24

AURORIX 300

Meclobemide 300 mg

Tablets

Antidepressant

Hoffman La ROCHE

Al Razi Pharmacy

CD (B)

25

BENZTRONE 5mg/ml

Oestradiol Benzoate 5mg/ml

Injection

New Medical Centre

CD (B)

BEPRO

Papaverine HCL 12.5mg, Codeine Sulphate 125mg, Calcium Iodide 1gm, Glycerine 5gm/100ml

Syrup

Cough Suppressant

Wallace (MFG. Chemists Ltd.)

Arabian Ethicals

CD (B)

Mixture

Antitussive, Expectorant, Decongestant

Dar Al Dawa

Al Mufid pharm.

CD (B)

Mixture

Antitussive, Expectorant

Dar Al Dawa

Al Mufid pharm.

CD (B)

26

27

BRONCHOLAR

28

BRONCHOLAR forte

Dextromethorphan HBr 7.5mg Guaifenesin 50mg,Ephedrine HCl 7.5mg,Chlorpheniramine maleate 1.25mg/5ml Dextromethorphan HBr 15mg Ephedrine HCL 7.5mg,Guaifenesin

Hormone Paines & Byrne Ltd. replacement therapy

Page 23 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

29

BRONCHOPHANE

Dextromethorphan HBr 125mg Diphenydramine HCl 100mg,Ephedrine HCl 150mg,Guaifenesin 1gm/100ml

Syrup

Antitussive, Expectorant

E.I.P.I.C.O

Pharmatrade

CD (B)

30

BUSPAR 10

Buspirone 10mg B i HCL 10

Tablets T bl t

Anxiolytic A i l ti

Bristol-Myers Squibb B i t lM S ibb

BUSPAR 30 mg

Buspirone HCl 30 mg

Tablets Dividose

Anxiolytic

BRISTOL MYERS CO., USA

32

BUSPAR 5

Buspirone HCL 5 mg

Tablets

Anxiolytic

Bristol-Myers Squibb

Modern Pharmaceutical Co.

CD (B)

33

CAMCOLITE 250

Lithium Carbonate 250mg

Tablets

Antidepressant

Norgine Ltd.

Pharmalink

CD (B)

34

CAMCOLITE 400

Lithium Carbonate 400mg

Tablets

Antidepressant

Norgine Ltd.

Pharmalink

CD (B)

35

CANTOR 50 CIPRALEX 10mg

Minaprine 50mg Escitalopram (as Escitlopram oxalate) 10mg/tablet Escitalopram (as Escitlopram oxalate) 15mg/tablet Escitalopram (as

Tablets Tablets

Antidepressant Antidepressant

Sanofi-Clin-Midy H.LUNDBECK A/S

City Pharmacy Modern Pharmacy Co.

CD (B)

Tablets

drugs* Antidepressant

Tablets

drugs* Antidepressant

31

36 CIPRALEX 15mg 37 CIPRALEX 20mg 38

CD (B) CD (B)

CD (B) H.LUNDBECK A/S

Modern Pharmacy Co. CD (B)

Escitlopram oxalate) 20mg/tablet

Modern Pharmaceutical Co. Modern Pharmacy Co.

H.LUNDBECK A/S

Modern Pharmacy Co. CD (B)

drugs*

Page 24 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

CIPRALEX 5mg

Escitalopram (as Escitlopram oxalate) 5mg/tablet

Tablets

Antidepressant

H.LUNDBECK A/S

Modern Pharmacy Co.

CIPRAM 20

Citalopram 20 mg

Tablets

CITALOGEN 10mg

Citalopram Hydrobromide 10mg Citalopram Hydrobromide 20mg Citalopram Hydrobromide 40mg

Tablets

39 40 41 42 43

44

45

CITALOGEN 20mg CITALOGEN 40mg

DISP. CD (B)

drugs*

Tablets Tablets

Antidepressant Antidepressant Antidepressant Antidepressant

Lundbeck RIYADH PHARMA RIYADH PHARMA RIYADH PHARMA

Modern Pharmaceutical Co.

CD (B)

Gulf Drug Est

CD (B)

Gulf Drug Est

CD (B)

Gulf Drug Est

CD (B)

CLIMEN

Micronised Estradiol Valerate(pink) 2mg/1tab, Micronised Estradiol Valerate(white) 2mg/1tab, Micronised Cyproterone Acetate (Pink) 1mg/1 tab.

Tablets

Hormone replacement therapy

Schering AG

Pharmaworld

CD (B)

CODAPHED

Codeine phosphate 8mg Chlorpheniramine maleate 2mg , Ephedrine HCL 15mg/10ml

Syrup

Antitussive , Decongestant , Antihistaminic

Julphar

Julphar

CD (B)

Page 25 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No.

46

47

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

Codaphed Plus

Chlorpheniramine Maleate Ephedrine HCl,Codeine Phosphate,Ammonium Chloride

Syrup

Flu & Cough

Julphar

Julphar

CD (B)

Syrup

Antihistaminic, Antitussive, Decongestant

Al Nile Co.

Pharmatrade

CD (B)

Syrup

Antitussive, Expectorant

Heinrich Mack

Pharmatrade

CD (B)

CODILAR

48 CODIPRONT Cum Exp.

49

CODIS

50

COLDEX-D

51

CYMBALTA 30

52

CYMBALTA 60

Dextromethorphan HBr100mg Phenylephrine HCL 40mg,Chlorpheniramine maleate 20mg/100ml Codeine 200mg , Guaiphenesine 1gm,Phenyltoloxamine 66mg , Thyme ext. 1gm/100ml Aspirin 500 mg,Codeine Phosphate 8 mg Dextromethorphan HBr 10mg , Pseudoephedrine Duloxetine HCl 30 MG Duloxetine HCl 60 MG

REMARKS

1 Tablets

Analgesic

Reckitt Benckiser

City Pharmacy

CD (B)

Syrup

Anti-allergic, Decongestant,

A.P.M

Modern Pharmaceutical Co.

CD (B)

Capsules

Antidepressant drugs*

LILLY SA

Pharmatrade

CD (B)

Capsules

Antidepressant drugs*

LILLY SA

Pharmatrade

CD (B)

Page 26 of 49

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

53

DECA DURABOLIN 25mg/ml

Nandrolone Decanoate 25mg/ml

Injection

Anabolic Steroids

Organon N.V./Holland

Modern Pharmaceutical Co.

CD (B)

54

DECA DURABOLIN 50mg/ml

Nandrolone Decanoate 50mg/ml

Injection

Anabolic Steroids

Organon N.V./Holland

Modern Pharmaceutical Co.

CD (B)

55

DECUTAN 10

Isotretinoin 10mg

Capsules

Anti-acne

ACTAVIS HF.

Metropolitan Medical Marketing[

CD (B)

56

DECUTAN 20

Isotretinoin20mg

Capsules

Anti-acne

ACTAVIS HF.

Metropolitan Medical Marketing[

CD (B)

DEXTROKUF

Dextromethorphan HBr

Syrup

Antitussive

Kuwait Saudi Pharmaceutical Industries Co. (KSPICO), KUWAIT

New Medical Centre

57

58

DEXTROLAG

59

DIARSED

15mg/5ml Dextromethorphan HBr 10mg , Guaifenesin 100mg, Chlorpheniramine maleate 2mg,Amonium chloride 25mg/5ml Diphenoxylate HCL 2.5mg , Atropine sulphate 0.025mg

CD (B)

Syrup

Antitussive, Expectorant

Lagap SA

New Medical Center

CD (B)

Tablets

Antidiarrhoeal

Sanofi-Clin-Midy

City Pharmacy

CD (B)

Page 27 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

60

DIAXINE

Diphenoxylate HCl 2.5mg, Atropine sulphate 0.025mg

Tablets

Antidiarrhoeal

Al Hikma Pharm.

Al Hayat Pharm.

CD (B)

61

DISTALGESIC

Propoxyphene HCL 32.5mg Paracetamol 325mg

Tablets

Analgesic

Eli Lilly &Co.

Pharmatrade

CD (B)

62

EDRONAX 4mg

Tablets

Antidepressant

Pharmacia & Upjohn S.p.A.

Modern Pharmaceutical Co.

CD (B)

63

EFEXOR 50

Venlafaxine 37.5mg

Tablets

Antidepressant

Wyeth Ayerst Canada

64

EFEXOR 37.6

Venlafaxine 50mg

Tablets

Antidepressant

Wyeth Ayerst Canada

65

EFEXOR 75

Venlafaxine 75mg

Tablets

Antidepressant

Wyeth Ayerst Canada

66

EFEXOR XR 150

Capsules

Antidepressant

Wyeth Ayerst Canada

67

EFEXOR XR 75

Capsules

Antidepressant

Wyeth Ayerst Canada

68

ELIDEL 1%

pimecrolimus

Cream

atopic dermatitis, eczema

Novartis Pharma

City Pharmacy

CD (B)

69

EMIKOFF

Dextropethorphane HBr 5 mg/5 ml

syrup

Antitussive, Expectorant

Global pharma

Global pharma

CD (B)

Reboxetine 4mg

Venlafaxine Hydrochloride 150mg Venlafaxine Hydrochloride 75mg

Page 28 of 49

Modern Pharmaceutical Modern Pharmaceutical Modern Pharmaceutical Modern Pharmaceutical Modern Pharmaceutical

Co. Co. Co. Co. Co.

CD (B) CD (B) CD (B) CD (B) CD (B)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

70

ESTRACOMB TTS

Oestradiol 4mg,Norethisterone acetate 30mg(Patch 1)+Oestradiol 10mg(Patch 2)

Patches

Hormone replacement therapy

Novartis Pharma

City Pharmacy

CD (B)

71

ESTRADERM TTS 100

Estradiol 8mg/20cm2

Patches

Hormone replacement therapy

Novartis Pharma

City Pharmacy

CD (B)

72

ESTRADERM TTS 25

Estradiol 2mg/5cm2

Patches

Hormone replacement therapy

Novartis Pharma

City Pharmacy

CD (B)

73

ESTRADERM TTS 50

Estradiol 4mg/10cm2

Patches

Hormone replacement therapy

Novartis Pharma

City Pharmacy

CD (B)

74

ESTROFEM

Oestradiol 2mg

Tablets

Hormone replacement therapy

Novo Nordisk

City Pharmacy

CD (B)

75

ESTROFEM FORTE

Oestradiol 4mg

Tablets

Hormone replacement therapy

Novo Nordisk

City Pharmacy

CD (B)

76

Evorex

Fluoxetine 20mg

Hard Gelatin Capsules

Antidepressant

JAZEERA PHARMACEUTICAL INDUSTRIES

Gulf Drug Est

CD (B)

77

EXEDEX

Dextromethorphan HBr 15mg

Tablets

Antitussive

Julphar

Julphar

CD (B)

Page 29 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME Dextromethorphan HBr 15mg/5ml Fluvoxamine maleate 50mg Fluvoxamine maleate 100mg

FORM

INDICATIONS

COMPANY

AGENT

DISP.

Syrup

Antitussive

Julphar

Julphar

CD (B)

Tablets

Antidepressant

Solvay Duphar B.V

Alphamed

CD (B)

Tablets

Antidepressant

Solvay Duphar B.V

Alphamed

CD (B)

78

EXEDEX

79

FAVERIN 50

80

FAVERIN 100

81

FEMOSTON 2/10

Dydrogesterone (Y) 10mg, Estradiol (O) 2.0mg, Estradiol (Y) 2.0mg

Tablets

82

FLEXIBAN

Cyclobenzaprine HCL 10mg/tab.

Tablets

Muscle relaxant

Algorithm S.A.L

City Pharmacy

CD (B)

83

FLOZAK 20

Fluoxetine 20 mg

Capsules

Antidepressant

RIYADH PHARMA

Gulf Drug Est.

CD (B)

84

Flumed DM Adult

Dextromethorphan HBr2 mg/5 ml

Syrup

Antitussive, Expectorant

RIYADH PHARMA

Gulf Drug Est.

CD (B)

85

FLUOXONE DIVULE

Fluoxetine 22.4mg

Capsules

Antidepressant

Laboratoires SMB

Metromed

CD (B)

86

FLUNEURIN 20mg

Fluoxetin 20mg/1capsule

Capsules

Antidepressant

Hexal AG

Alphamed (AUH) Ltd.

CD (B)

87

FLURAN

Fluoxetin 20mg/1capsule

Capsules

Antidepressant

RANBAXY LABORATORIES LTD.

Gigi Drug Store

CD (B)

FLUTIN

Fluoxetine Hydrochloride 20mg/5ml

Syrup

Antidepressant

Julphar

Julphar

88

Hormone Solvay Alphamed (AUH) Ltd. replacement therapy Pharmaceuticals B.V.

Page 30 of 49

CD (B)

CD (B)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME 89 FLUTIN 20mg FLUXETYL 20mg

GENERIC NAME Fluoxetine Hydrochloride 20mg Fluoxetine ( as F.

FORM

INDICATIONS

Capsules

Antidepressant

Julphar

Julphar

Capsules

Antidepressant

Kuwait Saudi Pharmaceutical Industries d i Co. (KSPICO), KUWAIT

New Medical Centre

20mg/capsule 91

GENOTROPIN 16 IU (5.3mg)

Somatropin 16IU/1Cartridge

92

GENOTROPIN 36 IU (5.3mg)

Somatropin 36IU/1Cartridge

93

INSIDON 50

Opipramol 50mg

94

INTARD

Diphenoxylate HCl 2.5mg, Atropine sulphate 0.025mg

IXEL 25mg

AGENT

DISP. CD (B)

y ) Hydrochloride)

90

COMPANY

Powder for Injection Powder for Injection

CD ((B))

Growth hormone

Pharmacia & Upjohn AB

Al Razi Pharmacy

CD (B)

Growth hormone

Pharmacia & Upjohn AB

Al Razi Pharmacy

CD (B)

Tablets

Antidepressant

Novartis Pharma

City Pharmacy

CD (B)

Tablets

Antidiarrhoeal

Julphar

Julphar

CD (B)

Antidepressant

Pierre Fabre Medicament Laboratories, FRANCE

City Pharmacy Co.

Milnacipran 25mg/capsule Capsules

95

Page 31 of 49

CD (B)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

IXEL 50mg

Milnacipran

Capsules

Antidepressant

Pierre Fabre Medicament Laboratories, FRANCE

City Pharmacy Co.

96 505mg/capsule Dextromethorphan HBr g 15mg/5ml Procyclidine HCL 10mg/2ml

DISP. CD (B)

Syrup

Antitussive

Spimaco

City Pharmacy

CD (B)

Injection

Parkinsonism

Glaxo wellcome

Al Baker Trading

CD (B)

Procyclidine HCL 5mg

Tablets

Parkinsonism

Glaxo wellcome

Al Baker Trading

CD (B)

KLIOGEST

Oestradiol 2mg,Norethisterone 1mg

Tablets

Hormone replacement therapy

Novo Nordisk

City Pharmacy

CD (B)

101

LAGAFLEX

Carisoprodol 300 mg,Paracetamol 250mg

Tablets

Muscle relaxant,Analgesic

Lagap SA

New Medical Center

CD (B)

102

LINZ 20

Fluoxetin 20mg/1capsule

Capsules

Antidepressant

Alphamed (Shj.) Ltd.

CD (B)

103 104

LIORESAL 10 LIORESAL 25

Baclofen 10 mg Baclofen 25 mg

Tablets Tablets

Muscle relaxant Muscle relaxant

Tabuk Pharmaceutical MFG Co. Novartis Pharma Novartis Pharma

City Pharmacy City Pharmacy

CD (B) CD (B)

105

LOMOTIL

Diphenoxylate HCl 2.5mg, Atropine sulphate 0.025mg

Tablets

Antidiarrhoeal

Searle Pharm.

Al Baker Trading

CD (B)

106 107 108

LUDIOMIL 10 LUDIOMIL 25 LUDIOMIL 50

Maprotiline HCL 10mg Maprotiline HCL 25mg Maprotiline HCL 50mg

Tablets Tablets Tablets

Antidepressant Antidepressant Antidepressant

Novartis Pharma Novartis Pharma Novartis Pharma

City Pharmacy City Pharmacy City Pharmacy

CD (B) CD (B) CD (B)

97

KAFOSED

98

KEMADRIN 10mg/2ml

99

KEMADRIN 5mg

100

Page 32 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

109

LUDIOMIL 75

Tablets

Antidepressant

CD (B)

MENTEX Syrup

syrup

Antitussive, Expectorant

Novartis Pharma Tabuk Pharmaceutical MFG

City Pharmacy

110

Maprotiline HCL 75mg dextromethorphan Hydrobromide

Alphamed

CD (B)

111

MUSCADOL

Orphenadrine citrate 35mg , Paracetamol 450mg

Tablets

Muscle relaxant,Analgesic

Julphar

Julphar

CD (B)

112

Neocoff - DM

Guaifenesin 100mg, Pseudoephedrine 30mg, Dextromethorphan 10mg

Syrup

Antitussive, Expectorant, Decongestant

Neopharma

New Medical Centre

CD (B)

113

NORACOD

Codeine 10mg,Paracetamol 500mg

Tablets

Analgesic,Antipyreti c

Jordanian Pharm.MFG(J.P.M)

Al Noor Medical Store

CD (B)

NORCURON 10mg

Vecuronium Bromide 10mg/ampoule

Powder for injection

Muscle relaxant

Organon Teknika B.V.

Modern Pharmaceutical Co.

115

NORCURON 4mg

Vecuronium Bromide 4.0mg/ampoule

Powder for injection

Muscle relaxant

Organon Teknika B.V.

Modern Pharmaceutical Co.

CD (B)

116

NORDITROPIN 12IU

Somatropine 12 IU

Injection

Growth hormone

Novo Nordisk

City Pharmacy

CD (B)

117

NORDITROPIN 4IU

Somatropine 4 IU

Injection

Growth hormone

Novo Nordisk

City Pharmacy

CD (B)

118

NORDITROPIN Pen set 12

Somatropine 12 IU

Injection S/C

Growth hormone

Novo Nordisk

City Pharmacy

CD (B)

114

REMARKS

Hospital use CD (B)

Hospital use

Page 33 of 49

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No.

119

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

NORDITROPIN Pen set 24

Somatropine 24 IU

Injection S/C

Growth hormone

Novo Nordisk

City Pharmacy

CD (B)

Somatropin Norditropin SimpleXx g/ 10mg/1.5ml 120

j/ Inj/ Solution

CD ((B)) Growth hormone

Novo Nordisk A/S

City Pharmacy

Somatropin 121

Norditropin SimpleXx 15mg/1.5 ml

Inj/ Solution

CD (B) Growth hormone

Somatropin 122

Norditropin SimpleXx 5mg/1.5 ml

123

Norditropin Nordilet 5mg/1.5 ml

Somatropin 124

Norditropin Nordilet 10mg/1.5 ml

City Pharmacy CD (B)

Growth hormone Somatropin

Novo Nordisk A/S

Inj/ Solution

Inj in Prefilled pen

Novo Nordisk A/S

City Pharmacy CD (B)

Growth hormone

Novo Nordisk A/S

City Pharmacy

Inj in Prefilled pen

CD (B) Growth hormone

Page 34 of 49

Novo Nordisk A/S

City Pharmacy

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME 125

FORM

Somatropin

Inj in Prefilled pen

Norditropin Nordilet 15mg/1.5 ml

126

NORFLEX

127

NORFLEX 100

128

NORGESIC

129

GENERIC NAME

Nuvaring

Orphenadrine citrate g 30mg/ml Orphenadrine citrate 100mg Orphenadrine citrate 35mg Paracetamol 450mg Etonogestrel & Ethinylestradiol

INDICATIONS

COMPANY

AGENT

DISP. CD (B)

Growth hormone

Novo Nordisk A/S

City Pharmacy

Injection

Muscle relaxant

3M Health Care

Alphamed

CD (B)

Tablets

Muscle relaxant

3M Health Care

Alphamed

CD (B)

Tablets

Muscle relaxant,Analgesic

3M Health Care

Alphamed

CD (B)

Organon N.V

Modern Pharmaceutical Co.

CD (B)

Vaginal Ring

Contarceptive

130

OXETINE

Fluoxetine Hydrochloride 20mg

Tablets

Antidepressant

Jordan Pharmaceutical Manufacturing

Al Noor Medical Store

CD (B)

131

PARACODOL

Codeine phosphate 8mg , Paracetamol 500mg

Eff.Tab.

Analgesic,Antipyreti c

Fisons Pharm.

Al Razi Pharmacy

CD (B)

132

PARACODOL

Codeine phosphate 8mg , Paracetamol 500mg

Tablets

Analgesic,Antipyreti c

Fisons Pharm.

Al Razi Pharmacy

CD (B)

Page 35 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

133

PHENSEDYL

Codeine phosphate 8.9mg Promethazine HCL 3.6mg Ephedrine HCL 7.2mg/5ml

Linctus

Antihistaminic, Antitussive

May&Baker RhonePoulenc

Pharmatrade

CD (B)

134

PRIMOTESTONE depot 100mg

Testosterone Enanthate 110mg, Testosterone Propionate 25mg, =Testosterone 100mg /ml

Injection

Male sex hormones

Schering AG/ Germany

Pharmaworld

CD (B)

135

PRIMOTESTONE depot 250mg

Testosterone enanthate 250mg/1ml

Injection

Male sex hormones

Schering AG/ Germany

Pharmaworld

CD (B)

136 137

PROTHIADEN 25 PROTHIADEN 75

Dothiepin HCl 25mg Dothiepin HCl 75mg

Capsules Tablets

Boots Co. Boots Co.

Al Baker Trading Al Baker Trading

CD (B) CD (B)

138

PROTOPIC 0.1%

Tacrolimus 0.1g/100g

Ointment

Al Hikma Pharm.

Al Hayat Pharm.

CD (B)

139

PROTOPIC 0.03%

Tacrolimus 0.03g/100g

Ointment

Antidepressant Antidepressant atopic dermatitis, eczema atopic dermatitis, eczema

Al Hikma Pharm.

Al Hayat Pharm.

CD (B)

140

PROVIRON

Mesterolone 25mg

Tablets

Male sex hormones

Schering AG

Pharmaworld

CD (B)

Page 36 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

141

PROZAC

Fluoxetine 20mg

Tablets

Antidepressant

Eli Lilly &Co.

Pharmatrade

CD (B)

142

PROZAC

Fluoxetine 20mg/5ml

Liquid

Antidepressant

Eli Lilly &Co.

Pharmatrade

CD (B)

PROZAC Weekly 90mg

Fluoxetine ( as F. Hydrochloride) 90mg/capsule

Capsules

Antidepressant

Eli Lilly & Co Inc.

Pharmatrade

143 144

REMERON 15 mg

Mirtazapine 15mg

Tablets

Antidepressant

Organon N.V

145

REMERON 30 mg

Mirtazapine 30mg

Tablets

Antidepressant

Organon N.V

146

REMERON 45 mg

Mirtazapine 45mg

Tablets

Antidepressant

Organon N.V

Remeron Sol Tab 30mg

Mirtazapine

Tablets

147

148

Codeine Phosphate 10mg, Paracetamol 500mg/1 tab.

Tablets

Modern Pharmaceutical Co. Modern Pharmaceutical Co.

CD (B) CD (B)

Modern Pharmaceutical Co.

CD (B)

Modern Pharmaceutical Co.

CD (B)

Modern Pharmaceutical Co.

CD (B)

Organon N.V Antidepressant

REVACOD

CD (B)

Analgesic

Page 37 of 49

A.P.M

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

149

RHINOTUSSAL

150

RIAPHAN 15mg/5ml

151

ROACCUTANE 10

Dextromethorphan HBr 20mg Phenylephrine HCL 20mg,Carbinoxamine maleate 4mg Dextromethorphan HBr 15mg/5ml Isotretinoin 10mg

FORM

INDICATIONS

COMPANY

AGENT

DISP.

Capsules

Decongestant, Expectorant

Heinrich Mack

Pharmatrade

CD (B)

Syrup

Antitussive

Riyadh Pharma

Capsules

Anti-acne

Hoffman La ROCHE

Modern Pharmaceutical Co. Al Razi Pharmacy

CD (B) CD (B)

152

ROACCUTANE 2.5

Isotretinoin 2.5mg

Capsules

Anti-acne

Hoffman La ROCHE

Al Razi Pharmacy

CD (B)

153

ROACCUTANE 20

Isotretinoin 20mg

Capsules

Anti-acne

Hoffman La ROCHE

Al Razi Pharmacy

CD (B)

154

ROACCUTANE 5

Isotretinoin 5mg

Capsules

Anti-acne

Hoffman La ROCHE

Al Razi Pharmacy

CD (B)

155

ROBAXIN

Methocarbamol 100mg/ml

Injection

Muscle relaxant

A.H.Robins

Pharmatrade

CD (B)

156

ROBAXIN 500

Methocarbamol 500mg

Tablets

Muscle relaxant

A.H.Robins

Pharmatrade

CD (B)

157

ROBAXISAL

Methocarbamol 400mg,Aspirin 325mg

Tablets

Muscle relaxant

A.H.Robins

Pharmatrade

CD (B)

Syrup

Antitussive,Expector ant, Decongestant

Richmonf Div. of Wyeth

Pharmatrade

CD (B)

Drops

Antitussive, Expectorant

Hoffman La ROCHE

Al Razi Pharmacy

CD (B)

158

ROBITUSSIN-CF

159

ROMILAR 1.5%

Dextromethorphan HBr 10mg , Guaifenesin 100mg,Pseudoephedrine HCl 30mg /5ml Dextromethorphan 15mg/ml

Page 38 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

160

ROMILAR 15

Dextromethorphan 15mg

Dragees

Antitussive, Expectorant

Hoffman La ROCHE

Al Razi Pharmacy

CD (B)

161

ROMILAR EXPECTORANT

Syrup

Antitussive, Expectorant

Hoffman La ROCHE

Al Razi Pharmacy

CD (B)

162 163

Serono Industri Mepha Ltd.

Arabian Ethicals Arabian Ethicals

CD (B) CD (B)

Novartis Pharma

City Pharmacy

CD (B)

Novartis Pharma

City Pharmacy

CD (B)

Novartis Pharma

City Pharmacy

CD (B)

Novartis Pharma

City Pharmacy

CD (B)

Novartis Pharma

City Pharmacy

CD (B)

SAIZEN 4 IU SALIPAX

Dextromethorphan 3.06mg , Ammonium chloride 18mg, Panthenol 11mg/1ml Somatropine 4 IU Fluoxetine 20mg

Injection Capsules

164

SANDOSTATIN 0.05

Octreotide 0.05mg/ml

Injection

165

SANDOSTATIN 0.1

Octreotide 0.1mg/ml

Injection

166

SANDOSTATIN 0.2

Octreotide 0.2mg/ml

Injection

167

SANDOSTATIN 0.5

Octreotide 0.5mg/ml

Injection

168

SANDOSTATIN LAR 10mg

Octreotide 10mg

Injection

Growth hormone Antidepressant Gastroenteropancreatic tumors Gastroenteropancreatic tumors Gastroenteropancreatic tumors Gastroenteropancreatic tumors Gastroenteropancreatic tumors

Page 39 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

169

SANDOSTATIN LAR 20mg

Octreotide 20mg

Injection

170

SANDOSTATIN LAR 30mg

Octreotide 30mg

Injection

171

SAROTEN Retard 25

Amitriptyline HCL 25 mg

Capsules

172

SAROTEN Retard 50

Amitriptyline HCL 50 mg

173

INDICATIONS

COMPANY

AGENT

DISP.

Novartis Pharma

City Pharmacy

CD (B)

Novartis Pharma

City Pharmacy

CD (B)

Antidepressant

Lundbeck

Modern Pharmaceutical Co.

CD (B)

Capsules

Antidepressant

Lundbeck

Modern Pharmaceutical Co.

CD (B)

SEDOFAN DM

Dextromethorphan HBr 10mg Triprolidine 1.25mg, Pseudoephedrine HCL 30mg/5ml

Syrup

Antitussive, Expectorant

Julphar

Julphar

CD (B)

174

SEROXAT 20

Paroxetine 20mg

Tablets

Antidepressant

Smith Kline Beecham

Gulf Drug Est.

CD (B)

175

SERZONE 100mg

Nefazodone HCL 100mg

Tablets

Antidepressant

176

SERZONE 150mg

Nefazodone HCL 150mg

Tablets

Antidepressant

177

SERZONE 200mg

Nefazodone HCL 200mg

Tablets

Antidepressant

Bristol laboratories corp. Bristol laboratories corp. Bristol laboratories corp.

Modern Pharmaceutical Co. Modern Pharmaceutical Co. Modern Pharmaceutical Co.

Gastroenteropancreatic tumors Gastroenteropancreatic tumors

Page 40 of 49

CD (B) CD (B) CD (B)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

178

SERZONE 250mg

Nefazodone HCL 250mg

Tablets

Antidepressant

Bristol laboratories corp.

Modern Pharmaceutical Co.

CD (B)

179

SERZONE 50mg

Nefazodone HCL 50mg

Tablets

Antidepressant

SIRDALUD 2

Tizanidine 2mg

Tablets

Muscle relaxant

Modern Pharmaceutical Co City Pharmacy

CD (B)

180

Bristol laboratories corp Sandoz Pharma

181

SIRDALUD 4

Tizanidine 4mg

Tablets

Muscle relaxant

Sandoz Pharma

City Pharmacy

CD (B)

Tablets

Muscle relaxant,Analgesic

Dumex

Gulf Drug Est.

CD (B)

Syrup

Antitussive

Plough Inc.

Gulf Drug Est.

CD (B)

Carisoprodol 200mg Paracetamol 160mg,Caffeine 182 SOMADRYL compound 32mg

183

ST.JOSEPH cough

Dextromethorphan HBr 0.1179%w/w

Page 41 of 49

CD (B)

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

184

STERANDRYL RETARD 250mg

Testosterone Hexahydrobenzoate 125mg, Transhexahydroterephtalate of n-butyl and Testosterone 125mg/ampoule

Injection

Male sex hormones

Roussel Laboratories/ France

Al Razi Pharmacy

CD (B)

185

STIVANE 300

Capsules

Antidepressant

Beaufour Lab.

Medical Scient.Est.

CD (B)

186

SURMONTIL 25

Tablets

Antidepressant

May&Baker RhonePoulenc

Pharmatrade

CD (B)

187

SURMONTIL 50

Trimipramine maleate 69.75mg

Capsules

Antidepressant

May&Baker RhonePoulenc

Pharmatrade

CD (B)

SUSTANON 250mg

Testosterone Propionate 30mg, Testosterone Phenylpropionate 60mg, Testosterone isocaproate 60mg, Testosterone decanoate 100mg

Injection

Male sex hormones

Organon N.V./Holland

Modern Pharmaceutical Co.

CD (B)

188

Pyrisuccideanol dimaleate 300mg Trimipramine maleate 35mg

Page 42 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

189

TAMIFLU

Oseltamivir

Tablets

Antiviral

Roche,Switzerland

Al Razi Pharmacy

CD (B)

190

TICLID

Ticlopidine 250mg

Tablets

Inhibitor of platelets agregation

Sanofi-Clin-MidyLabaz

City Pharmacy

CD (B)

191

TICOPAR

Ticlopidine 250mg

Tablets

Inhibitor of platelets agregation

Julphar

Julphar

CD (B)

192

TIXYLIX

Linctus

Antihistaminic, Antitussive

May&Baker RhonePoulenc

Pharmatrade

CD (B)

193 194

TOFRANIL 10 TOFRANIL 25

Pholcodine 1.5mg Promethazine HCL 1.5mg/5ml Imipramine 10mg Imipramine 25mg

Tablets Tablets

Antidepressant Antidepressant

Ciba-Geigy Novartis Pharma

City Pharmacy City Pharmacy

CD (B) CD (B)

195

TRETIN 10

Isotretinoin 10mg

Capsules

Anti-acne

P.N.Gerolymatos S.A.

Al Inma

CD (B)

196

TRETIN 20

Isotretinoin 20mg

Capsules

Anti-acne

P.N.Gerolymatos S.A.

Al Inma

CD (B)

Page 43 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No.

197

198

199

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

TREXAN 50

Naltrexone HCL 50mg

Tablets

Opioid antagonist

Dupont Pharm.

City Pharmacy

CD (B)

TRIPOFED DM

Dextromethorphan HBr10mg/5ml Triprolidine HCl 1.25mg/5ml Pseudoephedrine HCl 30mg/5ml

Syrup

Antihistaminic, Expectorant

KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES CO.

New Medical Centre

CD (B)

TRISEQUENS

Oestradiol 2mg(blue tab),Oestradiol 2mg,Norethisterone acetate 1mg(white tab),Oestradiol 1mg(red tab)

Tablets

Novo Nordisk

City Pharmacy

CD (B)

Hormone replacement therapy

Page 44 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

200

TRISEQUENS forte

Oestradiol 4mg(yellow tab),Oestradiol 4mg,Norethisterone acetate 1mg(white tab),Oestradiol 1mg(red tab)

Tablets

Hormone replacement therapy

Novo Nordisk

City Pharmacy

CD (B)

201

TRYPTIZOL 25

Amitriptyline HCL 25 mg

Tablets

Antidepressant

Merck Sharp&Dohme

City Pharmacy

CD (B)

202

TUSCALMAN

Noscapine HCL 15mg , Aether Guaiacolglycerinatus 100mg/10ml

Syrup

Antitussive

Berna(Swiss serum vaccine)

Modern Pharmaceutical Co.

CD (B)

Codeine phosphate 75mg Chlorpheniramine maleate 25mg,Glyceryl guaicolate 203 TUSSIFIN with codeine 1gm,Sodium benzoate 3gm,Potassium citrate 3gm,Liquorice 7.5gm/100ml

Syrup

Antihistaminic, Antitussive

ArabPharm.MFG. (A.P.M)

Modern Pharmaceutical Co.

CD (B)

Page 45 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

UNIFED DM

Triprolidine HCl 1.25 mg,

Syrup

Antitussive

The United

Gulf Drug Est.

Pseudoephedrine (HCl)

204

205

VECURONIUM BROMIDE FOR INJECTION 10mg

HBr 10 mg/5ml Vecuronium Bromide

CD (B)

Pharmaceutical

30mg, Dextromethorphan

DISP.

Manufacturing Co. Ltd.

Muscle relaxants*

10mg/1 vial

Powder for Injection

ABBOTT

City Pharmacy CD (B)

LABORATORIES

206

VESANOID 10mg

Tretinoin 10mg

Capsules

Anti-acne

Hoffman La ROCHE

Al Razi Pharmacy

CD (B)

207

VIRORMONE 10mg

Testosterone Propionate 10mg

Injection

Male sex hormones

Paines & Byrne Ltd./U.K.

New Medical Center

CD (B)

208

VIRORMONE 10mg

Tablets

Male sex hormones

New Medical Center

CD (B)

209

VIRORMONE 25mg

Tablets

Male sex hormones

New Medical Center

CD (B)

210

VIRORMONE 25mg

Testosterone Propionate 25mg

Injection

Male sex hormones

New Medical Center

CD (B)

211

ZOLOFT

Sertraline 50mg

Tablets

Antidepressant

Al Baker Trading

CD (B)

212

ZYBAN

bupropion 150MG

Tablets

Smoking cessation

Al Baker Trading

CD (B)

Testosterone Propionate 10mg Testosterone Propionate 25mg

Page 46 of 49

Paines & Byrne Ltd./U.K. Paines & Byrne Ltd./U.K. Paines & Byrne Ltd./U.K. Pfizer Limited GLAXO WELLCOME SA[

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

CD(B) [ 2007-2008 ]

No. TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

REDUCTIL 10mg

Sibutramine

Capsules

Anorectic

Abbott GmbH

Gulf Drug Est.

REDUCTIL 15mg 214

POM

Hydrochloride

213

Monohydarte 10mg Sibutramine

DISP.

Capsules

Anorectic

Abbott GmbH

Gulf Drug Est. Est POM

Hydrochloride Monohydarte 15mg

Page 47 of 49

REMARKS The prescription must be kept in the pharmacy for Inspection The prescription must be kept in the pharmacy for Inspection

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

( NARCOTICS ) [ 2007-2008 ]

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

1

CONCERTA 36 mg

Methylphenidate HCL 10mg

Tablets

Narcolepsy, hyperactivity in children

Alza Corporation, California;USA

Modern Pharmaceutical Co.

Narcotic

2

CONCERTA 18 mg

Methylphenidate HCL 36mg

Tablets

Narcolepsy, hyperactivity in children

Alza Corporation, California;USA

Modern Pharmaceutical Co.

Narcotic

3

Durogesic 100mcg/h

Fentanyl 16.8 mg / 1 Patch

Patch

Opioid Analgesic

Janssen Pharmaceuticals NV

City Pharmacy

Narcotic

4

Durogesic 12mcg/h

Fentanyl 2.1 mg / 1 Patch

Patch

Opioid Analgesic

Janssen Pharmaceuticals NV

City Pharmacy

Narcotic

5

Durogesic 25mcg/h

Fentanyl 4.2 mg / 1 Patch

Patch

Opioid Analgesic

Janssen Pharmaceuticals NV

City Pharmacy

Narcotic

6

Durogesic 50mcg/h

Fentanyl 8.4 mg / 1 Patch

Patch

Opioid Analgesic

Janssen Pharmaceuticals NV

City Pharmacy

Narcotic

7

Durogesic 75mcg/h

Fentanyl 12.6 mg / 1 Patch

Patch

Opioid Analgesic

Janssen Pharmaceuticals NV

City Pharmacy

Narcotic

8

PHYSEPTONE

Methadone HCL 10mg/ml

Injection

Analgesic,Adjunct in opoid dependance

Wellcome Foundation

Al Baker Trading

Narcotic

Page 48 of 49

REMARKS

‫دولة اإلمارات العربية المتحدة‬ ‫وزارة الصحة‬ ‫إدارة الرقابة الدوائية‬ ‫قسم الشؤون الفنية‬ ‫شعبة التسجيل الدوائي و التسعيرة‬

UNITED ARAB EMIRATES MINISTRY OF HEALTH DRUG CONTROL DEPARTMENT TECHNICAL AFFAIRS SECTION DRUG REGISTRATION AND PRICING UNIT

LIST OF RESTRICTED AND CONTROLLED DRUGS

( NARCOTICS ) [ 2007-2008 ]

TRADE NAME

GENERIC NAME

FORM

INDICATIONS

COMPANY

AGENT

DISP.

9

PHYSEPTONE 5

Methadone HCL 5mg

Tablets

Analgesic,Adjunct in opoid dependance

Wellcome Foundation

Al Baker Trading

Narcotic

10

RITALIN 10

Methylphenidate HCL 10mg

Tablets

Novartis Pharma AG

y Pharmacy y City

Narcotic

11

RITALIN SR 20mg

Methylphenidate HCL 20mg/1tab.

Tablets

Novartis Pharma AG

City Pharmacy

Narcotic

12

SOSEGON 50mg

Pentazocine HCL 56.4mg

Tablets

Opioid Analgesic

Sterling Winthrop

Al Baker Trading

Narcotic

13

SUBUTEX 2mg

Buprenorphine HCL 2mg/1tab.

Tablets

Opoids dependance

Schering-Plough Ltd.

City Pharmacy

Narcotic

14

SUBUTEX 8mg

City Pharmacy

Narcotic

15

ULTIVA 1mg

Al Baker Trading

Narcotic

16

ULTIVA 2mg

Al Baker Trading

Narcotic

17

ULTIVA 5mg

Al Baker Trading

Narcotic

Narcolepsy, yp y in hyperactivity children Narcolepsy, hyperactivity in children

Buprenorphine HCL 8mg/1tab. Remifentanil 1mg/vial Remifentanil 2mg/vial

Tablets

Opoids dependance

Injection

Opoid analgesic

Injection

Opoid analgesic

Remifentanil 5mg/vial

Injection

Opoid analgesic

Page 49 of 49

Schering-Plough Ltd. Glaxo wellcome operations Glaxo wellcome operations Glaxo wellcome operations

REMARKS