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MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 37/2008/QD-BYT
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Hanoi, November 20, 2008
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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:
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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
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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.
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- 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
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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
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Oral administration:
Various forms
6
Altretamin
Oral administration:
Various forms
7
Amitriptyline
chlorhydrate
Oral administration:
Various forms: Orally administered solution
8
Amphotericin B
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9
Anetholtrihion
Oral administration:
Various forms
10
Anti-D
immunoglobuline human
Injection: Powder
for solution for injection
11
Apomorphine
Oral administration:
Various forms
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Aprotinin
Injection: Solution
for infusion
13
Atenolol
Injection: Solution
for infusion
14
Atropin
Injection: Solution
for injection 1mg/ml
Eye drops: 1%
solution
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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
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Betaxolol
Eye drops
19
Bromocriptin
Oral administration:
Various forms
20
Buspirone
chlorhydrate
Oral administration:
Various forms
21
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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
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25
Carbidopa
Oral administration:
breakable tablets
26
Cefoxitin
Injection: Powder
for solution for intravenous injection
27
Celiprolol
Oral administration:
Various forms
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Cethexonium bromide
Eye drops
29
Chlorpromazine
Injection: Solution
for injection
Oral administration:
oral drops
30
Cibenzoline
Oral administration:
Various forms
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Clofazimine
Oral administration:
Various forms
32
Clomipramine
Oral administration:
Various forms
33
Clonazepam
Oral administration:
Various forms
Injection: Solution
for injection
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Clonidine
Injection: Solution
for injection
Oral administration:
Various forms
35
Codeine
Oral administration:
Syrup
36
Cholestyramine
Oral administration:
Powder pack
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Colistin (Colimycin)
Injection: Solution
for injection
Oral administration:
Various forms
38
Corticorelin
Hypothalamus hormone
diagnosis
39
Cortivazol
Injection: mixture
for injection
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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
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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
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Topical
administration: Ear spray
47
Dexchlorpheniramine
maleate
Injection: Solution
for injection
48
Diethylcarbamazin
Oral administration:
Various forms
49
Digitoxin
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50
Digoxin
Injection: Solution
for intravenous injection
Oral administration:
Orally administered solution
51
Dihydroergotamin
Oral administration:
tablets
52
Diltiazem
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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
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56
Dorzolamide
Eye drops: eye
ointment, intravitreal solution
57
Droperidol
Injection: Solution
for injection
58
Ephedrine
Injection: Solution
for injection
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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
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Injection: Solution
for injection
63
Estradiol
Transdermal patch
64
Etoposide
Oral administration:
Various forms
65
Exemestan
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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
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Fludrocortison
acetate + lidocain clorhydrat + polymyxin
Ear drops
70
Fluindioin
Oral administration:
Various forms
71
Flunitrazepam
Oral administration:
Various forms
72
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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
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Injection: Solution
for injection
76
Fuller 's Earth
(Clay)
Oral administration:
Various forms
77
Fusidic Acid
Oral administration:
Various forms
78
Glatiramer
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79
Glucose 1-phosphat
di Natri tetrahydrat
Injection: Solution
for infusion
80
Halofantrin
hydrochloride
Oral administration:
tablets
81
Haloperidol
Oral administration:
oral drops
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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
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Injection: Solution
for injection
86
Hydralazine
Injection: Solution
for injection
Oral administration:
Various forms
87
Hydroxycarbamide
Oral administration:
Various forms
88
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Oral administration:
Various forms
89
Hydroxyzine
Injection: Solution
for injection;
Oral administration: Various forms
90
Indometacin
Suppository
91
Interferon bêta-1a
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92
Interferon bêta-1b
Injection: Various
forms
93
Iohexol
Injection: Solution
for injection (for diagnosis)
94
Iopamidol
Injection: Solution
for injection
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Ipratropi bromide
Nose spray
96
Isoprenaline
Injection: Solution
for injection
Oral administration:
Various forms
97
Isosorbid
Injection: Solution
for intravenous injection
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Ivermectin
Oral administration:
Various forms
99
Josamycin
Oral administration:
Various forms
100
Potasium chloride
Injection: Solution
for injection
Oral administration:
Orally administered solution
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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
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L-Cystin; Soufre
precipit …
Oral administration:
tablets for solution
105
Leucovorin
Injection:
intravenous injection;
Oral administration: Various forms
106
Levonorgestrel
Intrauterine
suppository
107
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Injection:
Lyophilized powder for solution for injection
108
Lorazepam
Oral administration:
Various forms
109
Loxapin
Injection: Solution
for injection
Oral administration:
Various forms
110
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Oral administration:
tablets
111
Magnesi sulfate
Injection: Solution
for intravenous injection
112
Magnesium chloride
Injection: 10%
solution for injection
113
Mangan
glycerophosphate + Ammoni dihydrogenophosphate
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114
Mechlorethamine
Injection: Various
forms
115
Mecophenolate
mofetil
Injection: Solution
for intravenous injection
116
Medroxyprogesteron
Oral administration:
Various forms
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Mefloquine
Oral administration:
Various forms
118
Meladinine
(Methoxsalen)
Topical
administration
119
Melphalane
Oral administration:
Various forms
120
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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
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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
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Injection: Solution
for injection
127
Molsidomin
Oral administration:
tablets
128
Montelukast
Oral administration:
5mg tablets
129
Morniflumate
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130
Morphine sulfate
Oral administration:
Extended-release capsule
131
Nalbuphin
Injection: Solution
for injection
132
Naloxon
Injection: Solution
for injection
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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
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Injection: 25%
solution for injection
137
Nelfinavir
Oral administration:
Various forms
138
Nicardipin
Oral administration:
Various forms
Injection: Solution
for intravenous injection
139
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Oral administration:
Various forms
140
Nitroglycerin
Transdermal patch
Injection: Solution
for injection
Spray solution
Sublingual tablets
141
Nitroprussiat
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142
Octreotid
Injection: Solution
for injection
143
Oxybuprocain
Eye drops
144
Papaverin
Injection: Solution
for injection
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Acid
Para-aminobenzoic
Oral administration:
Various forms
146
Paroxetin
Oral administration:
Various forms
147
Pemirolast
Eye drops
148
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Oral administration:
Various forms
149
Permethrin
Topical
administration: Various forms
150
Phenylephrin
Eye drops: solution
151
Phenytoin
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152
Phloroglucinol
Injection: Solution
for injection
153
Phytomenadion
Oral administration:
oral emulsion, tablets
154
Pilocarpine
1%, 2% eye drop
solution
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Podophyllotoxin
Topical
administration: Topical solution
156
Polystyrene
sulfonate
Oral administration:
powder for oral solution
Rectal enema:
mixture
157
Praziquantel
Oral administration:
Various forms
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Prednisolon +
Naphazolin
Nose spray
159
Pristinamycin
Oral administration:
Various forms
160
Procain chlohydrate
Injection: Solution
for injection
161
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Oral administration:
Various forms
162
Promegeston
Oral administration:
Various forms
163
Propafenon
Oral administration:
Various forms
164
Propranolol
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165
Protamine
Injection: Solution
for injection
166
Quinidine
Oral administration:
Various forms
167
Quinine
Injection: Solution
for injection
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168
Raubasine
dihydroergocristine
Injection: Solution
for injection
169
Retinol
Eye drops: eye
ointment
170
Salbutamol
Injection: Solution
for injection
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171
Selegiline
Oral administration:
Various forms
172
Somatropin
Injection:
Lyophilized powder for solution for injection
173
Sotalol
Injection: Solution
for intravenous injection
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174
Sufentanil
Injection: Solution
for injection
175
Sulfamethoxazol
400mg + Trimethoprim 80mg
Injection: Solution
for infusion
176
Sulfasalazin
Oral administration:
Various forms
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Sulproston
Injection: Lyophilized
powder for solution for injection
178
Sumatriptan
Injection: Solution
for injection
179
Sunitinib
Oral administration:
Various forms
180
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Injection: Solution
for injection
181
Tetracaine
Eye drops: solution
182
Tetracosactide
Injection: mixture intravenous injection, intramuscular injection
183
Tetrazepam
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184
Tiapride
Injection: Solution
for injection
185
Tioguanin
(6-Thioguanin)
Oral administration:
Various forms
186
Topiramate
Oral administration:
Various forms
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Topotecane
Injection: Powder
for solution for infusion
188
Triclabendazole
Oral administration:
Various forms
189
Trientine
Injection: Various
form;
Oral administration: Various forms
190
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Oral administration:
solution, tablets
191
Tropatepine
Oral administration:
Various forms
192
Trospium
Oral administration:
Various forms
193
Urapidil
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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)
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Verapamil
Injection: Solution
for injection;
Oral administration: Various forms
198
Vigabatrin
Oral administration:
Various forms
199
Warfarin
Oral administration:
Various forms
200
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Injection: Solution
for injection
201
Zidovudin
Injection: Solution
for injection;
Oral administration: Various forms
202
Zopiclon
Oral administration:
Various forms