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| THE MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
| No. : 08/2009/TT-BYT | Hanoi, July 01, 2009 |
CIRCULAR
LIST OF OVER-THE-COUNTER (OTC) DRUGS
Pursuant to Decree No. 188/2007/ND-CP dated December 27, 2007 of the Government defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to Pharmacy Law No. No. 34/2005/QH11 dated June 14, 2005;
To ensure the safety for the drug users and create favorable conditions for the patients to buy drug to treat minor illnesses and common symptoms by themselves. The Ministry of Health issues and guides the implementation the "List of OTC drugs" as follows:
Article 1. Issuing together with this Circular the "List of OTC drugs", including:
1. List of pharmaceutical drugs;
2. List of drugs originated from medicinal herbs.
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1. OTC drugs are the drug dispensed, sold and used without prescription;
2. Prescription drugs are the drugs if not used in accordance with the prescriber’s indication, they may be dangerous to life or health; it is required to follow the prescription when dispensing, retailing and using these drugs for the outpatients;
Article 3. Principle to develop the “List of OTC drugs”
1. The list of OTC drugs is developed on the basis of specific criteria of pharmacological properties and safety of the drug.
2. The list of OTC drugs is developed in accordance with actual use and supply of drug of Vietnam and with the reference of classification of OTC drugs (Over The Counter) from a number of countries such as Australia, the USA, European countries, Philippines, Singapore and China;
3. The list of OTC is modified and supplemented annually. In case of necessity, in order to ensure the user’s safety, a number of types of drug may be removed from the list of OTC drugs if they have serious adverse effect detected;
Article 4. Criteria for selection of OTC drugs
Drugs simultaneously satisfy the following criteria shall be selected in the list of OTC drugs:
1. The drug has low toxicity, does not generate decomposition products with toxicity has no serious adverse effects (adverse effects are the consequences of death, danger to life and hospitalization is required for treatment or prolonged treatment, causing permanent or severe disability, birth defect, congenital malformation and equivalent consequences, ...) that have been known and / or warned work of these effects.
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3. Drugs are indicated for the treatment of common diseases and patients can treat themselves, unnecessary examination, consultation and monitoring from the physician.
4. Simple route and form of administration (mainly the oral and administration) with the content and concentration suitable for self-treatment.
5. Drugs have little interaction with other drugs and common food and beverage;
6. Drugs do not cause the drug dependence.
Article 5. Application of “List of OTC drug”
1. The list of OTC drugs is the basis for classification of OTC drugs and prescription drugs. The OTC drugs are permitted for dispensation, sale and use without prescription;
2. The list of OTC drugs is the legal grounds for the formulation and promulgation of regulations and guidelines for the OTC drugs in registration, production, import, export, circulation, distribution of drug, information of drug advertisements and scope of activities of drug retail establishments.
3. For drugs indicated as contraceptive pills that are classified as OTC drugs in this List, the medical officers shall guide the use of drug prior to dispensation or sale to consumers.
4. Other scopes of application of List of OTC drugs shall be guided in the relevant documents;
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1. For drug retail establishments:
From the effective date of this Circular, the drug retail establishments are permitted to retail drugs without prescription for the drugs specified in the List of OTC drugs;
2. For drug production and trading establishments:
a) For dossiers to register drug circulation in Vietnam and dossier to import drug without registration number that have been submitted in the Drug Administration of Vietnam before the effective date of this Circular, the establishments must classify, modify and supplement documents related to the classification of drug under the provisions of this Circular before considering the issuance of registration number or import license;
b) For the drugs that already have their registration number or permitted for import before the effective date of this Circular:
- The drugs that are produced and imported within 12 months from the effective date of this Circular and put into circulation in the market shall be permitted for circulation to the their expiration;
- After 12 months from the effective date of this Circular, the establishments that must classify, update and supplement information on drug labels and drug facts related to the classification of drug under the provisions of this Circular shall be permitted for putting their drugs into circulation on the market;
Article 7. Implementation provision
1. This Circular takes effect 45 days after its signing date;
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3. Any difficulty arising during the implementation of this Circular should be promptly reported to the Ministry of Health (Drug Administration of Vietnam) for consideration and settlement./.
FOR THE MINISTER
DEPUTY MINISTER
Cao Minh Quang
LIST OF OTC DRUGS
(Issued together with Circular No. 08/2009/TT-BYT dated July 01, 2009)
1. LIST OF PHARMACEUTICAL DRUGS:
No.
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Route of administration, dosage form, limit of content and concentration
Note
1
Acetylcysteine
Oral administration: various forms
2
Acetylleucin
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
3
Acetylsalicylic acid (Aspirin) of pure form or mixed with vitamin C and / or citric acid and / or sodium bicarbonate and / or sodium salicylate
Oral administration: various forms
Topical administration: various forms
4
Alginic acid (sodium alginate) of pure form or mixed with compounds of aluminum and magnesium
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Amino acid of pure or mixed form (including form mixed with Vitamins)
Oral administration: various forms
Indication: supplemental amino acid and vitamins for body
6
Acid Aminobenzoic (Acid para aminobenzoic)\ Aminobenzoic acid (para aminobenzoic acid)
Oral administration: various forms
7
Pure or mixed Benzoic acid
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: lozenge
8
Pure or mixed boric acid
Topical administration
Eye drops and ointment
9
Citric acid mixed with sodium, potassium
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
10
Cromoglicic acid and forms of Natrium cromoglicat
Eye drops and ointment and nose drops with concentration limit by Cromoglicic acid ≤ 2%
11
Acid Dimecrotic Dimecrotic acid
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Folic Acid of pure form or mixed with iron and / or vitamins of group B, minerals and Sorbitol
Oral administration: various forms
Indications: prevention of anemia, nutritional supplements
13
Glycyrrhizinic acid (Glycyrrhizinat) mixed with a number of other active susbtances such as Chlorpheniramine maleate, dl-methylephedrin, Caffeine ...
Oral administration: various forms, including forms of lozenge
Topical administration
14
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
15
Salicylic Acid of pure or mixed form in topical finished products (mixed with Lactic acid, precipitated sulfur ...)
Topical administration
16
Acyclovir Aciclovir
Dermal drug with concentration of Acyclovir ≤ 5%
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
17
Albendazole
Oral administration: various forms
Indication: worm treatment
18
Dichlorobenzyl alcohol of mixed form in lozenge ingredients
Oral administration: lozenge
19
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
20
Alimemazine tartrate (Trimeprazine tartrate)
Oral administration: various forms
21
Allantoin mixed in topical ingredients, Suppository (Cao Cepae fluid; Heparin...)
Topical administration
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
22
Allatoin mixed with Vitamins and/or Chondroitin
Eye drops and ointment
23
Almagate
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Ambroxol pure or mixed form in topical finished products of cough, antipyretic or analgesic drug
Oral administration: various forms with limit of active ingredients as follows:
- Divided dose: Ambroxol chlorhydrate ≤ 30 mg/unit
- Undivided dose: Ambroxol chlorhydrate ≤ 0.8%
25
Amyllase of pure form or mixed with Protease and / or lipase and / or Cellulase
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Amylmetacresol of mixed form with finished products of lozenge (as essential oil, Bacitracin...)
Oral administration: lozenge
27
Argyron
Eye drops and ointment
Topical administration
28
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
29
Aspartate
Oral administration: various forms
30
Attapulgit
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
31
Azelastine
Eye drops and ointment and nose drops
32
Silver Sulphadiazine
Topical administration
33
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
34
Freeze-dried bacillus subtilis
Oral administration: various forms
35
Bacitracin mixed with a number of active ingredients in finished products of lozenge (mixed with Neomycin sulfate; Amylocain; Tixocortol ...)
Oral administration: lozenge
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
.
36
Beclomethasone dipropionate
Nose drug: form of spray with limited maximum dosage for 01 day ≤ 400mcg (based on active ingredients without salt)
37
Benzalkonium mixed in topical finished products (with Choline; salicylic acid; Nystatin; Diiodohydroxyquin ...), in finished products of lozenge
Topical administration
Oral: lozenge
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
38
Benzocaine in mixed form
Topical administration: various forms with limited Benzocain ≤ 10%;
Suppository
Oral administration: lozenge
39
Benzoyl peroxide of pure form or mixed with iodine and / or sulfur
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
40
Benzydamin HCl of pure or mixed form
Topical administration: oral mucosa cream, mouthwash and throat spray
Oral administration: lozenge
41
Benzydamin salicylates of pure or mixed form
Topical administration
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
42
Benzyl benzoate mixed in topical finished products (with essential oil, Isopropyl alcohol ...)
Topical administration: various forms
Dermal patch
43
Berberin
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Biclotymol of pure form or mixed with Enoxolon and/or Phenylephrine HCl and / or Chlorpheniramine maleate and / or essential oil
Topical administration Nose drug
Oral administration: lozenge
45
Bifonazol of pure form or mixed with Urea
Topical administration
46
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms with divided dosage with content ≤ 10mg/unit
47
Boldin
Oral administration: various forms
48
Bromelain of pure form or mixed with Trypsin
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
49
Bromhexine HCl of pure or mixed form in finished products of cough, antipyretic and analgesic drug (as with Dextromethorphan HBr; Diphenhydramine; Guaiphenesin ...)
Oral administration: various forms with limited Bromhexin HCl as follows:
- Divided dosage ≤ 8mg/unit;
- Undivided dosage ≤ 0,8%
Suppository
50
Brompheniramin maleate of pure or mixed form in finished products of cough, antipyretic and analgesic drug
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
51
Budesonid
Budesonid
Bufexamac of pure or mixed form in topical finished products, suppository (as with titanium dioxide, bismuth, Subgallat, Lidocaine ...)
Nose drug: form of spray, inhaler and powder for inhalation with a limited maximum dosage for 01 day ≤ 400mcg and packed form≤ 200 dosages
Topical administration
Suppository
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Butoconazol
Topical administration
53
Calcium compounds (except for calcitriol) of single form or mixed with Vitamin D and / or Vitamins and / or Ipriflavon
Oral administration: various forms
Indication: Supplemental calcium for body
54
The compounds of aluminum, magnesium, calcium of pure or mixed form
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Indication: neutralizing gastric acid, gastric and duodenal ulcer treatment,.
55
Iron compounds
Oral administration: various forms
Indication: supplemental iron for body
56
Enzymes of pure form or mixed with vitamins
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
57
Bismuth salts
Oral administration: various forms
58
Magnesium salts
Oral administration: various forms
Indications: providing supplemental magnesium for body, neutralizing laxative gastric acid;
59
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
Indications: providing supplemental minerals for the body, including mixed forms with vitamins.
60
The essential oil (Menthol, Pinen, Camphor; Cineol, Fenchone, Borneol, anethole, Eucaliptol ...)
Oral administration: various forms
Dermal drug, mouthwash, throat spray and oral mucosa cream
61
Calamine of pure or mixed form in topical finished products
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
Oral administration: various forms with limited Pseudoephedrin (by base form) as follows:
- Divided dosage: ≤120mg/ unit;
- Unvided dosage: ≤ 0.5%
Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.
62
Carbocystein
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Carbomer
Topical administration
Eye drops and ointment
64
Catalase of pure or mixed form in topical finished products (with Neomycin)
Topical administration
65
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
66
Cetrimide mixed with a number of active ingredients in topical finished products (Lidocaine, Zinc, Calamine, Aminacrine, essential oil ...)
Topical administration
67
Cetrimonium mixed in topical finished products and lozenge (mixed with Lidocaine; Tyrothricin, essential oil ...)
Topical administration
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
68
Chitosan (Polyglusam)
Topical administration
69
Choline of pure form or mixed with amino acids and vitamins in oral finished products; mixed with salicylic acid, benzalkonium ...in topical finished products
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
70
Chondroitin of pure form or mixed with Glucosamine and / or fish oil and / or vitamins and / or amino acid
Oral administration: various forms
71
Chondroitin mixed with Vitamins
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
72
Chondroitin mixed in topical finished products
73
Ciclopirox olamine
74
Cimetidin
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
75
Cinarizin
Oral administration: various forms
76
Cinchocaine mixed in topical finished products, suppository (as with hydrocortisone, neomycin, Esculin ...)
Topical administration
Suppository
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
77
Citrulline
Oral administration: various forms
78
Clobetason butyrate
79
Clorhexidin
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
80
Clorophyll
Oral administration: various forms
81
Clorpheniramine maleate of pure or mixed form in finished products of cough, antipyretic and analgesic drug (mixed with with Phenylephrine HCl, paracetamol, Dextromethorphan HBr ...)
Oral administration: various forms.
Pure form of divided dosage: Clorpheniramine maleate ≤ 4mg/
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Clorpheniramine maleate mixed and/or vitamins
Eye drops and ointment
83
Clotrimazol
Topical administration: various forms with limited concentration ≤ 3%
Vaginal tablet
84
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
85
Crotamiton
86
Copper sulfate
87
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Dexbrompheniramin maleat of pure or mixed form in in finished products of cough, antipyretic and analgesic drug
Topical administration
Vaginal tablet
Oral: lozenge
Oral administration: various forms
88
Dexbrompheniramin maleat of pure or mixed form in in finished products of cough, antipyretic and analgesic drug
Oral administration: various forms
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
89
Dexibuprofen
Oral administration: various forms
90
Dexpanthenol
Eye drops and ointment
Topical administration
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Dextromethorphan HBr of pure or mixed form in in finished products of cough, antipyretic and analgesic drug
Oral administration: various forms with the following limit (by base form):
-Divided form: Dextromethophan ≤ 15mg;
- Undivided form: Dextromethophan ≤ 0.6%;
Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.
92
Diclofenac of pure form or mixed with Methyl salicylate, essential oil…
Topical administration
Eye drops and ointment (pure form)
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
93
Dicyclomine
Oral administration: various forms
94
Diethylphtalat (DEP)
Topical administration
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Dimenhydrinate
Oral administration: various forms
96
Dimethicone (Dimethylpolysiloxan) of pure form or mixed with với Guaiazulene
Oral administration: various forms
97
Dimethicon mixed in topical finished products (with zinc, calamine; Cetrimid ...)
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
98
Dimethindene
Oral administration: various forms
Topical administration
99
Inosine monophosphate dinatri
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
100
Diosmectite (Dioctahedral smectite)
Oral administration: various forms
101
Diosmin mixed with Hesperidin and/or a number of medicinal glue containing Flavonoid
Oral administration: various forms
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Diphenhydramine hydrochloride or monocitrat
Oral administration: various forms with the following limit (by base form):
- Divided dosage ≤ 50mg/unit;
- Undivided dosage: ≤ 2.5%
103
Domperidon
Oral administration: various forms with the following limit:
- Divided dosage ≤ 10mg/ unit;
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
104
Doxylamin mixed in finished products of cough, antipyretic and analgesic drug (as with Paracetamol;
Pseudoephedrin HCl;
Dextromethorphan HBr; Vitamins...)
Oral administration: various forms with limited Pseudoephedrin as follows (by base form):
- Divided dosage ≤ 120mg/ unit;
- Undivided dosage ≤ 0.5%
Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Econazole of pure form or mixed with Hydrocortison
Topical administration, limited concentration of Hydrocortison by base form≤ 0.05%
106
Enoxolone of pure or mixed form in topical finished products and lozenges
Topical administration: Dermal drug, oral mucosa cream, mouthwash
Oral administration: lozenge
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Ephedrin HCl
Eye and nose drug: lotion ≤ 1%
108
Eprazinon
Oral administration: various forms
109
Esdepallethrin mixed in topical finished products (with Piperonyl, Spregal, essential oil…)
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
110
Estradiol in pure form and mixed with Dydrogesteron
Oral administration: drug with divided dosage
Indication: contraception
111
Ethanol of pure or mixed form
Topical use (antiseptic alcohol)
Oral administration: mixed form
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
112
Ethinylestradiol in pure form and mixed with Cyproteron
113
Ethylestradiol in pure form and mixed with Desogestrel
114
Ethylestradiol in pure form and mixed with Gestodene
115
Ethylestradiol in pure form and mixed with Levonorgestrel
116
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
117
Famotidin
Oral administration: various forms
To be sold without prescription for 15 days of use
118
Fenticonazol
Topical administration
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
119
Fexofenadin
Oral administration: various forms
120
Flurbiprofen
Lozenge
Topical administration
Eye drops and ointment
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
121
Glucosamin of pure form or mixed with Chondroitin and/or with Vitamins
Oral administration: various forms
122
Glucose or Dextrose of pure form or mixed with sodium, potassium
Oral administration: various forms
Indication: supplemental sugar and electrolytes.
123
...
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Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
Eye drops and ointment
124
Glycerol mixed with herbal extracts
Drug of rectal enema
125
Guaiphenesin of pure or mixed form in finished products of cough, antipyretic and analgesic drug (with Paracetamol; Pseudoephedrin HCl; Dextromethorphan HBr...)
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Divided dosage form ≤120mg/ unit;
- Undivided dosage form ≤ 0.5%
Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.
126
Hexamidin of pure form or mixed (with Cetrimid, Lidocain, Clotrimazol, Catalase)
Topical administration
127
Hexetidin of pure form or mixed (with Benzydamin, Cetylpyridinum, Cholin Salicylat, Methyl salicylat, essential oil...)
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
128
Hydrocortison of pure form or mixed (with Miconazol, Econazol, Tioconazol, Neomycin)
Topical administration: various forms with concentration of Hydrocortison ≤ 0.5%
129
Hydrogen Peroxid of pure form or mixed with Sodium Lauryl Sulfate and / or essential oil ...
Topical administration
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Hydrotalcit
Oral administration: various forms
131
Hydroxypropyl methylcellulose (HPMC)
Eye drops and ointment
132
Hypromellose of pure form or mixed with Dextran 70
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
133
Ibuprofen
134
Ichthammol
135
Indomethacin
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
136
Iodide mixed with Potassium iodide and / or benzoic acid and / or salicylic acid
Topical administration with concentration of iodine ≤ 5%
137
Isoconazol
138
Isopropyl Methylphenol
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
139
Ketoconazol of pure form or mixed with Zinc Pirythion and / or hydrocortisone and / or Trolamin
Topical administration: various forms with concentration of Ketoconazol ≤ 2%
140
Ketoprofen
141
Zinc oxide, Zinc pyrithion, zinc gluconate, zinc undecylenat of pure or mixed form in topical finished products
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
142
Zinc sulfate
Topical administration
Eye drops and ointment
143
Lactic acid bacillus of pure form or mixed with vitamins
Oral administration: various forms
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Lactitol
Oral administration: various forms
145
Lactobacllus acidophilus
Oral administration: various forms
146
Lactobacllus acidophilus of pure form or mixed with vitamins
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
147
Lactoserum atomisate (Lactacyd)
Topical administration
148
Lactulose
Oral administration: various forms
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Levocetirizin
Oral administration: various forms
150
Levonorgestrel of pure form or mixed with Ethylestradiol
Oral administration: various forms
Indication: contraception
151
Lindan (Benhexachlor, 666, Gamma-BHC) of pure form or mixed with Lidocain
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
152
Loperamid
Oral administration: various forms with a limited content of divided dosage of Loperamid ≤ 2mg
153
Loratadin of pure form or mixed with Pseudoephedrin HCl
Oral administration: various forms with limited content as follows (by base form):
- Divided dosage:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Pseudoephedrin ≤ 120mg/unit
- Divided dosage:
Loratadin ≤ 0.1%
Pseudoephedrin ≤ 0.5%
Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.
154
Loxoprofen
Oral administration: various forms
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Lysozym of pure form or mixed with Tocopherol, Nicotinate, Carbazochrom, Inositol Cetylpyridinium,...
Oral administration: various forms
Topical administration
156
Macrogol
Oral administration: various forms
Drug of rectal enema
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Magaldrat of pure form or mixed with the active ingredients of Aluminum, Magnesium, alginic acid (or alginate salt).
Oral administration: various forms
158
Mangiferin
Topical administration
159
Mebendazol
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Divided dosage form ≤ 500mg/unit
- Undivided dosage form ≤ 2%
160
Mebeverin
Oral administration: divided dosage form ≤ 200mg/unit
161
Fungal cellulase
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
162
Menthol mixed with a number of active ingredients such as mixed essential oil, Methyl Salycilat....
Oral administration: various forms
Topical administration: various forms
163
Mequinol
Topical administration
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
164
Mequitazine
Oral administration: various forms
Topical administration
165
Mercurocrom
Topical administration with packaging specifications ≤ 30ml
To be sold with no more than 2 packaging units/time
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Methyl salicylate mixed in finished products of lozenge and topical administration (mixed with essential oil…)
Topical administration
Dermal patch
Oral administration: lozenge
167
Metronidazol
Topical administration
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Miconazol
Topical administration
Vaginal cream≤ 2%
169
Miconazole mixed with Hydrocortison
Topical administration
Vaginal cream
Miconazol ≤2%; Hydrocortison ≤0.05%
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
170
Minoxidil
Topical administration: various forms with concentration of ≤5%
171
Mometasone
Nose drug: ≤ 50 mcg/time of spray with packaging specification≤ 200 dosages/box;
Topical administration
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Mupirocin
Topical administration
173
Myrtol of pure or mixed form in finished products of lozenge
Naphazolin of pure or mixed form in finished products of nose drug such as Diphenylhydramin and/or Procain
Oral administration: various forms
Nose drug with concentration of Naphazolin ≤ 0.05%
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
174
Naphazolin mixed in finished products of Eye drops and ointment (Pheniramin; Vitamin glycyrhizinat, Dexpanthenol...)
Eye drops and ointment: various forms with concentration of Naphazolin ≤ 0,1%
175
Naproxen
Oral administration: various forms with divided dosage of Naproxen ≤ 250mg/unit
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Sodium benzoate of pure or mixed form
Oral administration: various forms
177
Sodium bicarbonate of pure or mixed form
Oral administration: various forms
178
Sodium carbonate of pure or mixed form
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
179
Sodium carboxymethylcellulose (Na CMC)
Eye drops and ointment
180
Sodium chloride of pure form or mixed with potassium citrate, sodium citrate ...
Oral administration: various forms
Topical administration
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
181
Sodium Docusat
Oral administration: various forms
182
Sodium fluoride of mixed form
Topical administration:
Tooth cleaning and mouthwash
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
183
Natri Hyaluronat (Acid Hyaluronic)
Topical administration
184
Sodium Monofluorophosphat
Topical administration:
Tooth cleaning and mouthwash
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Sodium salicylate of mixed form
Oral administration: mixed form in lozenges
Topical administration
186
Neomycin sulfate mixed in finished products of lozenge (Zinc, Bacitracin; Amylocain ...) and topical finished products
Nomahydrated sodium sulfide + Saccharomyces Cerevisiae
Topical administration
Oral administration: various forms
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
187
Noscarpine
Oral administration: various forms
188
Nystatin of pure or mixed form
Topical administration
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Orlistat
Oral administration: various forms
190
Ossein hydroxy apatite
Oral administration: various forms
191
Oxeladin
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
182
Oxymemazin
Oral administration: various forms
193
Oxymetazoline
Nose drug with concentration ≤ 0,5%
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Pancreatin of pure form or mixed with Simethicon and / or digestive enzymes and / or the vitamins of group B and / or Azintamid
Oral administration: various forms
.
195
Panthenol
Topical administration
Eye drops and ointment
196
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
Suppository
Mixed form specified in the List
197
Paracetamol mixed with Ibuprofen and/or Cafeine
Oral administration: various forms
198
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
199
Paracetamol mixed with Promethazin HCl
Oral administration: various forms with limited content and concentration (by base form) as follows:
- Divided dosage: Promethazin ≤12.5mg/unit;
- Undivided dosage: Promethazin ≤ 0.1%
Suppository
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
200
Paracetamol mixed with Codein
Oral administration: various forms with limited Codein (by base form) as follows:
- Divided dosage form≤ 30mg/unit;
- Undivided dosage ≤ 2.5%
Finished products containing Codein are sold without prescription with a maximum amount for 10 days of use.
201
Paracetamol mixed with Pseudoephedrine HCl and/or Vitamin C and/or one of the active ingredients:
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Dextromethorphan HBr;
Phenylephrine HCl
Oral administration: various forms with the limit (by base form) as follows:
- Divided base form: Pseudoephedrin ≤ 120mg/unit;
Dextromethophan ≤ 15mg
- Undivided base form: Pseudoephedrin ≤ 0.5%
Dextromethophan ≤ 0.6%
Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.
202
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
203
Phenylephrin HCl
Eye drops and ointment and nose drop with concentration ≤ 1%
204
Phenylephrin HCl mixed in topical finished products (such as Petrolatum sperti yellow; Mineral oil light; Shark liver oil...)
Topical administration
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
205
Phenylephrin HCl mixed in finished products of cough, antipyretic and analgesic drug
Oral administration: various forms
Suppository
206
Phospholipid
Oral administration: various forms
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Picloxydine
Eye drops and ointment
208
Piracetam
Oral administration: various forms
209
Piroxicam
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
210
Policresulen (Metacresolsulphonic acid-formaldehyde)
Topical administration
Rectal tablets
211
Polymethylen glycol 400 of pure form or mixed with Propylen glycol
Eye drops and ointment
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
212
Polysacharid
Oral administration: various forms
213
Polytar of pure or mixed form in topical finished products (as Zinc Pyrithion ...)
Topical administration
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Povidon Iodin
Topical administration: various forms, including mouthwash with concentration ≤ 1%.
Eye drops and ointment
215
Promethazin HCl of pure or mixed in finished products of cough, antipyretic and analgesic drug (with Carbocystein; Paracetamol ...)
Oral administration: various forms with limited contents and concentration of Promethazin (by base form) as follows:
-Divided dosage ≤ 12.5mg/unit;
- Undivided dosage ≤ 0.1%
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
216
Pseudoephedrin HCl mixed with Cetirizin
Oral administration: various forms with limited Pseudoephedrin (by base form) as follows:
- Divided dosage ≤ 120mg/unit;
- Undivided dosage ≤ 0.5%
Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.
217
Pseudoephedrin HCl mixed in finished products of cough, antipyretic and analgesic drug
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
- Divided dosage ≤120mg/ unit;
- Undivided dosage ≤ 0,5%
Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.
218
Pyrantel
Oral administration: various forms
Indication: worm treatment
219
Ranitidine
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
To be sold without prescription for up to 15 days of use
220
Rotundin of pure form or mixed with herbal extract and glue
Oral administration: various forms
221
Rotundin of pure form or mixed with Vitamin C and/or herbal extract and glue
Oral administration: various forms
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Saccharomyces boulardic
Oral administration: various forms
223
Saccharomyces cerevisiae + Trihydrat Magnesi Sulfat
Oral administration: various forms
224
Hyocine (Scopolamin) butylbromid of pure form or mixed with Meclizin hydrochlorid
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms, including the chewable tablets with limited content of divided dosage ≤ 20mg
Dermal patch
225
Organic selenium of mixed form in finished products containing Vitamin and minerals
Oral administration: various forms with limited content as follows:
- Selen with divided dosage ≤ 50mcg/ unit
226
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
227
Silymarin of pure form or mixed with Vitamins and/or herbal extract and glue
Oral administration: various forms
228
Simethicone of pure form or mixed with Pancreatin and / or Desoxycholic acid and / or vitamin of group B and / or digestive enzymes
Oral administration: various forms
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
229
Simethicon mixed with the aluminum compound, magnesium, and / or dicyclomine and / or activated carbon
Oral administration: various forms
230
Sorbitol of pure or mixed form
Oral administration: various forms
231
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Oral administration: various forms
Drug of rectal enema
232
Sucralfate
Oral administration: various forms
233
Sulbutiamine
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
234
Sulfogaiacol of pure or mixed form in finished products of cough, antipyretic and analgesic drug (as mixed with Sodium benzoate, Dextromethophan ...)
Oral administration: various forms
235
Terbinafine
Topical administration: various forms with concentration ≤ 1%
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Terpin of pure form or mixed with Codeine
Oral administration: various forms.
Mixed form of Codeine (by base form) with limited content as follows:
- Divided dosage ≤ 30mg/unit;
- Divided dosage ≤ 2.5%
Finished products containing Codeine are sold without prescription with a maximum amount for 10 days of use.
237
Tetrahydrozoline
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
238
Activated carbon of pure form or mixed with Simethicone
Tioconazol of pure form or mixed with Hydrocortisone
Oral administration: various forms
Topical administration: various forms with concentration as follows:
- Tioconazol ≤ 1.00%
- Hydrocortison ≤ 0.05%
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
239
Tolnaftate
Topical administration
240
Tretinoin
Topical administration: various forms with concentration ≤ 0.05%
241
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
242
Triprolidine of pure or mixed form in finished products of cough, antipyretic and analgesic drug (as with Guaiphenesin, Paracetamol, Pseudoephedrin HCl, Dextromethophan HBr...)
Oral administration: various forms with limited Pseudoephedrin (by base form) as follows:
- Divided dosage ≤120mg/ unit;
- Undivided dosage ≤ 0.5%
Finished products containing Pseudoephedrin to be sold without prescription with a maximum amount for 15 days of use.
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Trolamine of pure or mixed form in topical finished products (with Triclosan and/or Tyrothricin)
Topical administration
244
Tyrothricin of mixed form (with Benzalkonium, Benzocain, Formaldehyd, Trolamin, essential oil...)
Oral administration: lozenge
Topical administration: Mouthwash and mouth spray
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Urea of pure form or mixed with Vitamin E and/or Bifonazol and/or medicinal materials (Aloe glue)
Topical administration
246
Vitamin A and provitamin A (Betacaroten)
Oral administration: various forms with Vitamin A ≤ 5000 IU /dosage unit
Topical administration
Eye drops and ointment
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Vitamin of group B, Vitamin PP of pure or mixed form
Eye drops and ointment
248
Vitamin and provitamin of pure form (excluding Vitamin A and Article) or mixed with Vitamins, minerals, amino acids, Taurine, fatty acid.
Oral administration: Vitamin A of mixed form ≤ 5000 IU/dosage unit
Topical administration
With the effect of supplemental vitamins, minerals and nutrients.
249
...
...
...
Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
Topical administration
250
Xylometazolin of pure form or mixed with Benzalkonium.
Nose drug with concentration of Xylometazolin ≤ 1%
2. LIST OF DRUGS ORIGINATED FROM MEDICINAL MATERIALS:
Drugs originated from medicinal materials whose ingredients do not contain high toxic medicinal materials (Ex: nux vomica, monkshood, gelsemium elegans benth, nerium oleander, strychnos wallichiana steud,…) or medicinal materials having serious adverse effects known/warned of these effects are classified as OTC drugs;
Drugs originated from medicinal materials whose ingredients contain high toxic medicinal materials (Ex: nux vomica, monkshood, gelsemium elegans benth, nerium oleander, strychnos wallichiana steud,…) or medicinal materials having serious adverse effects known/warned of these effect are classified according to each specific case;
Circular No. 08/2009/TT-BYT dated July 01, 2009, list of over-the-counter (OTC) drugs
- Số hiệu: 08/2009/TT-BYT
- Loại văn bản: Thông tư
- Ngày ban hành: 01/07/2009
- Nơi ban hành: Bộ Y tế
- Người ký: Cao Minh Quang
- Ngày công báo: Đang cập nhật
- Số công báo: Đang cập nhật
- Ngày hiệu lực: 15/08/2009
- Ngày hết hiệu lực: 15/08/2014
- Tình trạng hiệu lực: Kiểm tra
Đơn vị chủ quản: Công ty cổ phần tư vấn đầu tư và ứng dụng công nghệ 4.0.
Chịu trách nhiệm chính: Bà Phạm Hoài Thương.
Giấy chứng nhận ĐKDN số: 0108234370, do Sở Kế hoạch và Đầu tư thành phố Hà Nội cấp ngày 18/04/2018.
Địa chỉ: Thôn Trung, Xã Phù Đổng, TP Hà Nội - VPGD: C2 Vincom, 119 Trần Duy Hưng, Phường Yên Hòa, TP Hà Nội.
Điện thoại: 024.6294.9155 - Hotline 1: 0342.799.688 - Hotline 2: 0985.426.175 - Email: info@hethongphapluat.com
