Tóm tắt

Số hiệu37/2008/QĐ-BYT
Loại văn bảnQuyết định
Cơ quanBộ Y tế
Ngày ban hành20/11/2008
Người kýCao Minh Quang
Ngày hiệu lực 02/01/2009
Tình trạng Hết hiệu lực

Quyết định 37/2008/QĐ-BYT về Danh mục thuốc hiếm theo yêu cầu điều trị do Bộ trưởng Bộ Y tế ban hành

MINISTRY OF HEALTH
-------

SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------

No. 37/2008/QD-BYT

Hanoi, November 20, 2008

 

DECISION

PROMULGATION OF LIST OF RARE MEDICINES ONLY AVAILABLE ON REQUEST

THE MINISTRY OF FINANCE

Pursuant to the Government's Decree No. 188/2007/ND-CP dated December 27, 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Law on Pharmacy No. 34/2005/QH11 dated June 14, 2005;

Pursuant to the Prime Minister’s Decision No. 151/2007/QD-TTg dated September 12, 2007 of the Prime Minister on import of medicines that have not had registration numbers in Vietnam;

At the request of Director of Drug Administration of Vietnam,

DECIDES THAT:

Article 1. The list of rare medicines is promulgated together with this Decision.

Article 2. This Decision takes effect after 15 days from the day on which it is published on the Official Gazette.

Article 3. The Chief of the Ministry Office. the Chief Inspector, Director of Drug Administration of Vietnam, heads of units affiliated to the Ministry, Director of Services of Health are responsible for the implementation of this Decision./.

 

PP THE Minister
DEPUTY MINISTER



Cao Minh Quang

LIST

RARE MEDICINES ONLY AVAILABLE ON REQUEST(Promulgated together with the Decision No. 37/2008/QD-BYT dated November 20, 2008 of the Minister of Health) 

I. PURPOSE

In consideration of the conditions of medical facilities nationwide which are in the need for some medicines that are not available in Vietnam serving a limited number of patients or some medical techniques that have not been widely applied in Vietnam. In order to enable patients to have the medicines they need, the Ministry of Health promulgates a List of rare medicines.

II. RULES AND CRITERIA FOR COMPILING THE LIST OF RARE MEDICINES:

1. Rules:

- The use of the List of rare medicines shall be instructed in relevant documents.

- The list of rare medicines shall be adjusted periodically.

2. Criteria for selection:

A medicine in the List of rare medicine has to satisfy all of the criteria below:

- The medicine is not available in Vietnam (with regard to formula, concentration, and route of administration). There is not any similar medicine registered in Vietnam or there is a similar medicine that has a registration number but it is not sold or its supply is not sufficient.

- The medicine is used for a number of limited patients (inpatients or outpatients).

- The medicine is requested by medical facilities.

- The medicine is not on the list of Medicines not recommended by WHO.

- The medicine has be manufactured and used in one of member States of International Conference Harmonization (including: USA, Europe, Japan) or in one of the member State of Pharmaceutical Inspection Cooperation Scheme (PICs).

III. LIST OF RARE MEDICINES

No.

Active ingredient

Route of administration and/or dosage form and/or concentration

1

Acenocoumarol

Oral administration: Various forms

2

Acetazolamide

Injection: Powder for solution for injection

Oral administration: Various forms

3

Acetylcysteine

Injection: Solution for infusion

4

Aciclovir

Injection: Powder for solution for infusion

5

Acitretin

Oral administration: Various forms

6

Altretamin

Oral administration: Various forms

7

Amitriptyline chlorhydrate

Oral administration: Various forms: Orally administered solution

8

Amphotericin B

Injection: Solution for injection

9

Anetholtrihion

Oral administration: Various forms

10

Anti-D immunoglobuline human

Injection: Powder for solution for injection

11

Apomorphine

Oral administration: Various forms

12

Aprotinin

Injection: Solution for infusion

13

Atenolol

Injection: Solution for infusion

14

Atropin

Injection: Solution for injection 1mg/ml

Eye drops: 1% solution

15

Azathioprin

Oral administration: Various forms

16

Bacteries BCG

Injection: Solution for injection

17

Betamethasone

Oral administration: oral drops

Injection: Solution for injection; mixture for injection

18

Betaxolol

Eye drops

19

Bromocriptin

Oral administration: Various forms

20

Buspirone chlorhydrate

Oral administration: Various forms

21

Busulfan

Oral administration: Various forms

22

Coagulation factor II, VII, VIII, IX, X

Injection: various forms (as a single substance or combined with other elements)

23

Calcipotriol

Topical administration: Topical cream

24

Calcium chloride

Injection: 10% solution for infusion

25

Carbidopa

Oral administration: breakable tablets

26

Cefoxitin

Injection: Powder for solution for intravenous injection

27

Celiprolol

Oral administration: Various forms

28

Cethexonium bromide

Eye drops

29

Chlorpromazine

Injection: Solution for injection

Oral administration: oral drops

30

Cibenzoline

Oral administration: Various forms

31

Clofazimine

Oral administration: Various forms

32

Clomipramine

Oral administration: Various forms

33

Clonazepam

Oral administration: Various forms

Injection: Solution for injection

34

Clonidine

Injection: Solution for injection

Oral administration: Various forms

35

Codeine

Oral administration: Syrup

36

Cholestyramine

Oral administration: Powder pack

37

Colistin (Colimycin)

Injection: Solution for injection

Oral administration: Various forms

38

Corticorelin

Hypothalamus hormone diagnosis

39

Cortivazol

Injection: mixture for injection

40

Cromolyn sodium (Cromoglicate de Na)

Injection, oral administration, spray, intravitreal administration

41

Cyclopentolate

Eye drops: diagnostic solution

42

Dacarbazine

Injection: Powder for solution for infusion

43

Dantrolene

Oral administration: tablets

Injection: Lyophilized powder for solution for injection

44

Dapson

Oral administration: tablets (as a single substance or combined with other elements)

45

Desmopressin

Spray

46

Dexamethason + Oxytetracyclin + Polymyxin + Nystatin

Topical administration: Ear spray

47

Dexchlorpheniramine maleate

Injection: Solution for injection

48

Diethylcarbamazin

Oral administration: Various forms

49

Digitoxin

Oral administration: Various forms

50

Digoxin

Injection: Solution for intravenous injection

Oral administration: Orally administered solution

51

Dihydroergotamin

Oral administration: tablets

52

Diltiazem

Injection: Solution for injection

53

Dimercaprol

Injection: Solution for intramuscular injection (as a single substance or combined with other elements)

54

Dinoproston

Suppository: sterile vaginal gel, pre-filled syringe

55

Dipyridamol

Injection: Solution for injection

Oral administration: Various forms

56

Dorzolamide

Eye drops: eye ointment, intravitreal solution

57

Droperidol

Injection: Solution for injection

58

Ephedrine

Injection: Solution for injection

59

Eptifibatide

Injection: Solution for injection

60

Ergotamin

Oral administration: tablets (as a single substance or combined with other elements)

61

Erythromycin lactobionate

Injection: Powder for solution for infusion

62

Esmolol chlorhydrate

Injection: Solution for injection

63

Estradiol

Transdermal patch

64

Etoposide

Oral administration: Various forms

65

Exemestan

Oral administration: Various forms

66

Fibrinogen

Injection: Powder for solution for injection (as a single substance or combined with other elements)

67

Filgrastim

Injection: Solution for injection

68

Flecainide acetate

Solution for injection; Oral administration: Various forms

69

Fludrocortison acetate + lidocain clorhydrat + polymyxin

Ear drops

70

Fluindioin

Oral administration: Various forms

71

Flunitrazepam

Oral administration: Various forms

72

Fluorescein

Eye drops

Injection: Solution for intravenous injection

73

Recombinant follitropin alpha/ Follitropin beta

Injection: subcutaneous injection, intravenous injection

74

Fosfomycin trometamol

Oral administration: granules for oral solution

75

Fosphenyltoin

Injection: Solution for injection

76

Fuller 's Earth (Clay)

Oral administration: Various forms

77

Fusidic Acid

Oral administration: Various forms

78

Glatiramer

Injection: Powder for solution for injection

79

Glucose 1-phosphat di Natri tetrahydrat

Injection: Solution for infusion

80

Halofantrin hydrochloride

Oral administration: tablets

81

Haloperidol

Oral administration: oral drops

82

Calcium heparinate

Injection: Solution for injection

83

Human Chorionic Gonadotropin (HCG)

Injection: intramuscular injection, lyophilized powder tube

84

Human Menotropin Gonadotropin (HMG)

Injection: intramuscular injection, lyophilized powder tube

85

Snake antivenom serum (various type)

Injection: Solution for injection

86

Hydralazine

Injection: Solution for injection

Oral administration: Various forms

87

Hydroxycarbamide

Oral administration: Various forms

88

Hydroxychloroquine

Oral administration: Various forms

89

Hydroxyzine

Injection: Solution for injection;
Oral administration: Various forms

90

Indometacin

Suppository 

91

Interferon bêta-1a

Injection: Various forms

92

Interferon bêta-1b

Injection: Various forms

93

Iohexol

Injection: Solution for injection (for diagnosis)

94

Iopamidol

Injection: Solution for injection

95

Ipratropi bromide

Nose spray

96

Isoprenaline

Injection: Solution for injection

Oral administration: Various forms

97

Isosorbid

Injection: Solution for intravenous injection

98

Ivermectin

Oral administration: Various forms

99

Josamycin

Oral administration: Various forms

100

Potasium chloride

Injection: Solution for injection

Oral administration: Orally administered solution

101

Potasium iodide

Oral administration: Orally administered solution

102

Labetalol

Injection: Solution for injection

Oral administration: Various forms

103

Lauromacrogol 400 (Polidocanol, Aetoxisclerol)

Injection: Solution for injection

104

L-Cystin; Soufre precipit …

Oral administration: tablets for solution

105

Leucovorin

Injection: intravenous injection;
Oral administration: Various forms

106

Levonorgestrel

Intrauterine suppository

107

Linsidomin

Injection: Lyophilized powder for solution for injection

108

Lorazepam

Oral administration: Various forms

109

Loxapin

Injection: Solution for injection

Oral administration: Various forms

110

Levothyroxine

Oral administration: tablets

111

Magnesi sulfate

Injection: Solution for intravenous injection

112

Magnesium chloride

Injection: 10% solution for injection 

113

Mangan glycerophosphate + Ammoni dihydrogenophosphate

Oral administration: Effervescent tablet

114

Mechlorethamine

Injection: Various forms

115

Mecophenolate mofetil

Injection: Solution for intravenous injection

116

Medroxyprogesteron

Oral administration: Various forms

117

Mefloquine

Oral administration: Various forms

118

Meladinine (Methoxsalen)

Topical administration

119

Melphalane

Oral administration: Various forms

120

Mercaptopurine

Oral administration: Various forms

121

Mesalazine

Oral administration: Various forms

Rectal enema, rectal suppository; emulsion 

122

Methylergometrine

Oral administration: Orally administered solution

Injection: Solution for injection

123

Metoclopramide

Oral drops: 0.1 mg per drop

124

Mexiletine 

Injection: Various form;
Oral administration: Various forms

125

Milrinon

Injection: Solution for intravenous injection

126

Mitoxantron

Injection: Solution for injection

127

Molsidomin

Oral administration: tablets

128

Montelukast

Oral administration: 5mg tablets

129

Morniflumate

Rectal suppository

130

Morphine sulfate

Oral administration: Extended-release capsule

131

Nalbuphin

Injection: Solution for injection

132

Naloxon

Injection: Solution for injection

133

Sodium bicarbonat

Injection: 1.4%, 8.4% solution for injection

134

Sodium calcium edetate (E.D.T.A)

Injection: Solution for injection

135

Sodium chloride (NaCl)

Injection: 0.9% solution for injection in 250ml/500ml/1000ml plastic bag; 20% solution for injection in 10ml tube; 10% solution

136

Sodium thiosulfate

Injection: 25% solution for injection

137

Nelfinavir

Oral administration: Various forms

138

Nicardipin

Oral administration: Various forms

Injection: Solution for intravenous injection

139

Nilutamid

Oral administration: Various forms

140

Nitroglycerin

Transdermal patch

Injection: Solution for injection

Spray solution

Sublingual tablets

141

Nitroprussiat

Injection: Powder for solution for injection

142

Octreotid

Injection: Solution for injection

143

Oxybuprocain

Eye drops

144

Papaverin

Injection: Solution for injection

145

Acid Para-aminobenzoic

Oral administration: Various forms

146

Paroxetin

Oral administration: Various forms

147

Pemirolast

Eye drops

148

Penicillamin

Oral administration: Various forms

149

Permethrin

Topical administration: Various forms

150

Phenylephrin

Eye drops: solution

151

Phenytoin

Injection: Solution for injection

152

Phloroglucinol

Injection: Solution for injection

153

Phytomenadion

Oral administration: oral emulsion, tablets

154

Pilocarpine

1%, 2% eye drop solution

155

Podophyllotoxin

Topical administration: Topical solution

156

Polystyrene sulfonate

Oral administration: powder for oral solution

Rectal enema: mixture

157

Praziquantel

Oral administration: Various forms

158

Prednisolon + Naphazolin

Nose spray

159

Pristinamycin

Oral administration: Various forms

160

Procain chlohydrate

Injection: Solution for injection

161

Procarbazine

Oral administration: Various forms

162

Promegeston

Oral administration: Various forms

163

Propafenon

Oral administration: Various forms

164

Propranolol

Injection: Solution for injection

165

Protamine

Injection: Solution for injection

166

Quinidine

Oral administration: Various forms

167

Quinine

Injection: Solution for injection

Oral administration: as a single substance or combined with Thiamin

168

Raubasine dihydroergocristine

Injection: Solution for injection

169

Retinol

Eye drops: eye ointment

170

Salbutamol

Injection: Solution for injection

Suppository 

171

Selegiline

Oral administration: Various forms

172

Somatropin

Injection: Lyophilized powder for solution for injection

173

Sotalol

Injection: Solution for intravenous injection

Oral administration: Various forms

174

Sufentanil

Injection: Solution for injection

175

Sulfamethoxazol 400mg + Trimethoprim 80mg

Injection: Solution for infusion

176

Sulfasalazin

Oral administration: Various forms

177

Sulproston

Injection: Lyophilized powder for solution for injection

178

Sumatriptan

Injection: Solution for injection

179

Sunitinib

Oral administration: Various forms

180

Terbutaline

Injection: Solution for injection

181

Tetracaine

Eye drops: solution

182

Tetracosactide

Injection: mixture intravenous injection, intramuscular injection

183

Tetrazepam

Oral administration: Various forms

184

Tiapride

Injection: Solution for injection

185

Tioguanin (6-Thioguanin)

Oral administration: Various forms

186

Topiramate

Oral administration: Various forms

187

Topotecane

Injection: Powder for solution for infusion

188

Triclabendazole

Oral administration: Various forms

189

Trientine

Injection: Various form;
Oral administration: Various forms

190

Trihexyphenidyl

Oral administration: solution, tablets

191

Tropatepine

Oral administration: Various forms

192

Trospium

Oral administration: Various forms

193

Urapidil

Injection: Solution for injection

194

Valaciclovir

Oral administration: Various forms

195

Valproic Acid

Injection: Powder for solution for injection

196

Sterile vaseline

Sterile vaseline (used for surgery and endotracheal intubation)

197

Verapamil

Injection: Solution for injection;
Oral administration: Various forms

198

Vigabatrin

Oral administration: Various forms

199

Warfarin

Oral administration: Various forms

200

Methylene blue

Injection: Solution for injection

201

Zidovudin

Injection: Solution for injection;
Oral administration: Various forms

202

Zopiclon

Oral administration: Various forms

 

---------------

This document is handled by Dữ Liệu Pháp Luật . Document reference purposes only. Any comments, please send to email: [email protected]

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                            Số hiệu37/2008/QĐ-BYT
                            Loại văn bảnQuyết định
                            Cơ quanBộ Y tế
                            Ngày ban hành20/11/2008
                            Người kýCao Minh Quang
                            Ngày hiệu lực 02/01/2009
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