Nội dung toàn văn Circular 07/2017/TT-BYT promulgation of List of OTC drugs
MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No.: 07/2017/TT-BYT | Hanoi, May 03, 2017 |
CIRCULAR
PROMULGATION OF LIST OF OTC DRUGS
Pursuant to the Pharmaceutical Law dated April 06, 2016;
Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 defining Functions, Tasks, Powers and Organizational Structure of Ministry of Health;
At the request of Director of Drug Administration of Vietnam, Minister of Health promulgates the “Circular on promulgation of list of OTC drugs”.
Article 1. Scope
This Circular provides for rules for compiling the list of OTC drugs, criteria for selection of OTC drugs; List of OTC drugs; purposes and implementation thereof.
Article 2. Rules for compiling List of OTC drugs and criteria for selection of OTC drugs
1. Rules for compiling List of OTC drugs
a) Ensure safety for drug users;
b) Ensure people’s timely access to OTC drugs;
c) Conform to the reality of use and supply of drugs in Vietnam;
d) Be harmonized with rules and regulations on classification of OTC drugs announced by the States in the region and the world.
2. Criteria for selection of OTC drugs
Drugs that satisfy all criteria below shall be put on the List of OTC drugs:
a) Any drug with low toxicity, does not create toxic degradation products, does not have serious adverse reactions that are known or warned against by the World Health Organization, regulatory authorities of Vietnam or foreign countries, and may cause any of the following adverse effects:
- Cause death;
- Threaten life;
- Need hospitalization or prolonged treatment;
- Cause permanent or serious impairments;
- Cause congenital malformations;
- Cause other drug adverse reactions that may cause adverse clinical effects on patients as assessed and judged by medical practitioners.
b) The dosage range is wide and safe for various age groups, does not significantly affect the diagnosis and treatment of diseases that need clinical monitoring;
c) Drugs indicated to treat common diseases which can be treated by patients themselves without prescription and monitoring from medical practitioners;
d) Drugs of which the administration routes and dosage forms are simple (oral, topical administration), and the concentration are appropriate for self-treatment by patients;
dd) Drugs that rarely interact with other drugs or common foods and drinks;
e) Drugs that do not cause dependence;
g) Drugs that do not pose risks of overdose or misuse affecting the safety of drug users;
h) Drugs that have been selling in Vietnam for at least 05 years.
Article 3. List of OTC drugs
The List of OTC drugs is stated in the Appendix enclosed herewith.
Article 4. Purposes of List of OTC drugs
1. The List of OTC drugs is the basis for separating OTC drugs and prescription drugs. Drugs that are not listed on the List of OTC drugs must be classified as prescription drugs.
2. The List of OTC drugs is the basis for formulation and promulgation of regulations and instructions by regulatory authorities on registration, manufacture, export, import, distribution, advertising of OTC drugs, inspection and handling of violations and other relevant activities.
Article 5. Effect
1. This Circular takes effect as from July 01, 2017.
2. The Circular No. 23/2014/TT-BYT dated June 30, 2014 by Minister of Health on promulgation of List of OTC drugs shall be null and void as from the date of entry into force of this Circular.
Article 6. Transition provision
1. Drugs on the List of OTC drugs promulgated under this Circular shall be provided, retailed and used without prescription as from the entry into force of this Circular, unless they are classified as prescription drugs as written on drug labels (and package inserts) which must be provided, retailed and used according to prescriptions.
2. With regard to drugs that have registration numbers in Vietnam or import permits before this Circular takes effect:
a) With regard to drugs that are on the List of OTC drugs promulgated under the Circular No. 23/2014/TT-BYT but not on the List of OTC drugs enclosed herewith, holders of certificate of free sales and drug importers must classify, update and provide additional information concerning drug classifications in accordance with regulations herein on drug labels and package inserts according to the roadmap prescribed in Minister of Health’s Circulars on labeling of drugs and medicinal ingredients before such drugs are sold on the market.
b) With regard to drugs that are not on the List of OTC drugs promulgated under the Circular No. 23/2014/TT-BYT but on the List of OTC drugs enclosed herewith, since the entry into force of this Circular, holders of certificate of free sales and drug importers are encouraged to classify, update and provide additional information concerning drug classifications in accordance with regulations herein on drug labels and package inserts before selling drugs on the market; or drugs with approved drug classifications on labels and package inserts may be manufactured, imported and sold on the market until their expiry dates.
3. With regard to applications for drug registration in Vietnam and applications for permit to import drugs without certificate of free sale in Vietnam that are submitted to the Drug Administration of Vietnam before the date of entry into force of this Circular and are not yet processed:
a) With regard to drugs that are on the List of OTC drugs promulgated under the Circular No. 23/2014/TT-BYT but not on the List of OTC drugs enclosed herewith, applicants must carry out drug classifications under regulations herein;
b) With regard to drugs that are not on the List of OTC drugs promulgated under the Circular No. 23/2014/TT-BYT but on the List of OTC drugs enclosed herewith, applicants may carry out drug classifications according to submitted applications or in accordance with regulations herein.
Article 7. Implementation responsibility
1. Responsibility of pharmacy establishments and health facilities:
a) Implement regulations herein;
b) Propose revision to the List of OTC drugs in conformity with the reality to ensure the timely provision of drugs serving the prevention and treatment of diseases.
2. Responsibility of the Drug Administration of Vietnam:
a) Take charge of and cooperate with regulatory bodies in implementing this Circular;
b) Review the List of OTC drugs, except non-prescription traditional medicines, and submit reports thereof to the Minister of Health according to proposals and suggestions of units mentioned in Clause 1 herein or conclusion of the Advisory Council for issuance of certificate of free sale of drugs and medicinal ingredients.
3. Responsibility of the Traditional Medicine Administration of Vietnam:
a) Cooperate with the Drug Administration of Vietnam and regulatory bodies in implementing this Circular;
b) Review the List of non-prescription traditional medicines and submit reports thereof to the Minister of Health according to proposals and suggestions of units mentioned in Clause 1 herein or conclusion of the Advisory Council for issuance of certificate of free sale of drugs and medicinal ingredients.
Difficulties that arise during the implementation of this Circular should be promptly reported to the Drug Administration of Vietnam or the Traditional Medicine Administration of Vietnam (if related to traditional medicines) for consideration./.
| PP MINISTER |
LIST
OF OTC DRUGS
(Enclosed with the Circular No. 07/2017/TT-BYT dated May 03, 2017 by Minister of Health)
I. LIST OF OTC MODERN DRUGS AND BIOLOGICALS
No. | Active ingredients | Administration route, dosage form and concentration limit | Other regulations |
1 | Acetylcystein | Oral administration: various forms |
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2 | Acetylleucin | Oral administration: various forms |
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3 | Acetylsalicylic acid (Aspirin), as a single substance or combined with Vitamin C and/or citric acid and/or sodium bicarbonate and/or sodium salicylate | Oral administration: various forms | Indication: pain relief, fever relief, anti-inflammation |
4 | Alginic acid (Sodium Alginat) as a single substance or combined with compounds of aluminum, magnesium | Oral administration: various forms |
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5 | Amino acid as a single substance or combined with other substances (including combinations with vitamins) | Oral administration: various forms | Indications: supplementation of amino acids and vitamins |
6 | Aminobenzoic acid (para aminobenzoic acid) | Oral administration: various forms |
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7 | Benzoic acid as a single substance or combined with other substances | Topical administration Oral administration: lozenges |
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8 | Boric acid as a single substance or combined with other substances | Topical administration Intravitreal administration |
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9 | Acid citric combined with sodium, potassium salts | Oral administration: various forms |
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10 | Acid cromoglicic and various forms of cromoglicat salts | Intravitreal administration, nasal administration with ≤ 2% of cromoglicic acid |
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11 | Dimecrotic acid | Oral administration: various forms |
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12 | Folic acid as a single substance or combined with iron and/or B Vitamins, minerals, sorbitol | Oral administration: various forms | Indication: anaemia treatment, nutritional supplements |
13 | Glycyrrhizinic acid (Glycyrrhizinat) combined with other active ingredients such as Chlorpheniramin maleat, Dl-methylephedrin, Cafein, etc. | Oral administration: various forms, including lozenges Topical administration |
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14 | Lactic acid as a single substance or combined with other substances | Topical administration |
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15 | Mefenamic acid | Oral administration: various forms |
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16 | Salicylic acid as a single substance or combined with Lactic acid, precipitated sulfur, etc. in topical products | Topical administration |
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17 | Acyclovir | Topical administration: skin cream with Acyclovir concentration ≤ 5% |
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18 | Albendazol | Oral administration: various forms | Indication: vermifuge |
19 | Alcol diclorobenzyl combined with other substances in lozenges | Oral administration: lozenges |
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20 | Alcol polyvinyl | Topical administration |
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21 | Alimemazin tartrat (Trimeprazin tartrat) | Oral administration: various forms |
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22 | Allantoin combined with other substances in topical products, rectal suppositories (cepae fluid, etc.) | Topical administration Rectal suppositories |
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23 | Allatoin combined with Vitamins and/or Chondroitin | Intravitreal administration |
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24 | Almagat | Oral administration: various forms |
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25 | Ambroxol as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various forms with the following limits: - Divided dose: Ambroxol chlorhydrate ≤ 30mg/unit - Undivided dose: Ambroxol chlorhydrate ≤ 0.8% |
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26 | Amyllase as a single substance or combined with Protease and/or Lipase and/or Cellulase | Oral administration: various forms |
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27 | Amylmetacresol combined with essential oil, Bacitracin, etc. in lozenges | Oral administration: lozenges |
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28 | Argyron | Intravitreal administration Topical administration |
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29 | Aspartam | Oral administration: various forms |
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30 | Aspartat as a single substance or combined with other substances | Oral administration: various forms |
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31 | Attapulgit | Oral administration: various forms |
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32 | Azelastin | Intravitreal administration, nasal administration |
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33 | Sulphadiazin silver | Topical administration |
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34 | Bacitracin combined with some active ingredients in lozenges (Neomycin sulfat; Amylocain; Tixocortol, etc.) | Oral administration: lozenges |
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35 | Beclomethason dipropionat | Nasal administration: aerosol with maximum dose of 400 mcg per day, ≤ 200 doses per package (no-salt active ingredients) |
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36 | Benzalkonium combined with Cholin; acid salicylic; Nystatin; Diiodohydroxyquin, etc. in topical products, or combined with Tyrothricin, Bacitracin, essential oil, etc.in lozenges | Topical administration Lozenges |
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37 | Benzocain combined with other substances | Topical administration: various forms with Benzocain ≤ 10%; Rectal suppositories Oral administration: lozenges |
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38 | Benzoyl peroxid as a single substance or combined with Iod and/or sulfur | Topical administration: various forms with concentration ≤ 10% |
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39 | Benzydamin HCl as a single substance or combined with other substances | Topical administration: oral mucosa cream mouthwash, oral spray Oral administration: lozenges |
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40 | Benzydamin salicylate as a single substance or combined with other substances | Topical administration |
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41 | Benzyl benzoat combined with essential oil, Isopropyl, etc. in topical products | Topical administration: various forms Transdermal patch |
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42 | Berberin | Oral administration: various forms |
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43 | Biclotymol as a single substance or combined with Enoxolon and/or Phenylephrin HCl and/or Clorpheniramin maleat and/or essential oil | Topical administration Nsal administration Oral administration: lozenges |
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44 | Bifonazol as a single substance or combined with Urea | Topical administration |
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45 | Bisacodyl | Oral administration: divided dose with concentration ≤ 10 mg/unit |
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46 | Bismuth salt | Oral administration: various forms | Indication: treatment of heartburn |
47 | Boldine | Oral administration: various forms |
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48 | Bromhexine Hydrochloride as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various forms with limited Bromhexin Hydrochloride content: - Divided dose: ≤ 8mg/unit; - Undivided dose: ≤ 0,8% Rectal suppositories |
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49 | Bromelain as a single substance or combined with Trypsin | Oral administration: various forms |
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50 | Brompheniramin maleat as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various forms |
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51 | Budesonid | Nasal administration: aerosol, inhaler, powder for snorting with limited dose of 400 mcg per day, ≤ 200 doses per package |
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52 | Bufexamac as a single substance or combined with Titan Dioxid, Bismuth, Subgallat, Lidocain, etc. in topical products or rectal suppositories | Topical administration Rectal suppositories |
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53 | Butoconazol | Topical administration |
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54 | Caffeine combined with active ingredients on this list | Oral administration: various forms |
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55 | Calamin as a single substance or combined with topical products | Topical administration |
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56 | Calcium (including compounds) single ingredient or combined with Vitamin D (except Calcitriol) and/or Vitamins and/or Ipriflavon | Oral administration: various forms | Indications: supplementation of calcium |
57 | Carbinoxamine as a single substance or combined with Pseudoephedrin Hydrochloride and/or Bromhexin and/or Paracetamol in cough medicines, antipyretic drugs, pain relievers | Oral administration | Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses |
58 | Carbocystein | Oral administration: various forms |
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59 | Carbomer | Topical administration Intravitreal administration |
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60 | Catalase as a single substance or combined with Neomycin in topical products | Topical administration |
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61 | Cetirizin dihydrochlorid | Oral administration: various forms |
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62 | Cetrimid combined with some active ingredients in topical products (Lidocain, Zinc, Calamine, Aminacrine, essential oil, etc.) | Topical administration |
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63 | Cetrimonium in combined with other substances in topical products, lozenges (with Lidocain; Tyrothricin, essential oil, etc.) | Topical administration Oral administration: lozenges |
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64 | Chitosan (Polyglusam) | Topical administration |
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65 | Cholin as a single substance or combined with amino acids, Vitamins in orally administered products; combined with Salicylic acid, Benzalkonium, etc. in topical products | Oral administration: various forms Topical administration |
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66 | Chondroitin as a single substance or combined with Glucosamin and/or fish oil and/or Vitamins and/or amino acids | Oral administration: various forms |
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67 | Chondroitin as a single substance or combined with Borneol and/or Vitamins | Intravitreal administration Topical administration |
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68 | Ciclopirox olamin | Topical administration |
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69 | Cimetidin | Oral administration: divided dose withlimited concentration of Cimetidin ≤ 200 mg/unit | Indication: treatment of heartburn |
70 | Cinarizin | Oral administration: various forms |
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71 | Cinchocain combined with Hydrocortison, Neomycin, Esculin, etc. in topical products, rectal suppositories | Topical administration Rectal suppositories |
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72 | Citrullin | Oral administration: various forms |
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73 | Clobetason butyrat | Topical administration |
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74 | Clorhexidin | Topical administration |
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75 | Clorophyl | Oral administration: various forms |
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76 | Chlorpheniramine maleate as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various forms Divided dose in form of single substance: Chlorpheniramine maleate ≤ 4 mg/unit. |
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77 | Chlorpheniramine maleate combined with Chondroitin and/or Vitamins | Intravitreal administration |
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78 | Clotrimazol | Topical administration: various forms with concentration ≤ 3% Vaginal suppositories |
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79 | Codein combined with active ingredients on this list for the purpose of cough treatment, fever reduction, or pain relief | Oral administration: various forms with the following limits on Codeine concentration (bases): - Divided dose: ≤ 12mg/unit; - Undivided dose: ≤ 2.5% | Not more than 10 days’ dose of products that contain Codein may be sold without prescription Retailers must record buyers’ names and addresses |
80 | Coenzym Q10 as a single substance or combined with Vitamins | Oral administration: various forms |
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81 | Crotamiton | Topical administration |
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82 | Dequalinium as a single substance or combined with Tyrothricin, Hydrocortison, Glycyrrhetinic Acid, Lidocain, etc. in topical products, lozenges | Topical administration Vaginal suppositories Oral administration: lozenges |
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83 | Desloratadin | Oral administration: verious forms, concentration ≤ 5 mg/divided dose Or oral administration with maximum dose of 5mg per day |
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84 | Dexbrompheniramin maleat as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various forms |
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85 | Dexclorpheniramin maleat as a single substance or combined with other substances in cough medicines, antipyretic drugs, pain relievers | Oral administration: various forms |
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86 | Dexpanthenol | Intravitreal administration Topical administration |
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87 | Diclofenac as a single substance or combined with Methyl salicylat, substances of essential oil group, etc. | Topical administration Intravitreal administration (single form) |
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88 | Dicyclomin | Oral administration: various forms |
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89 | Diethylphtalat (DEP) | Topical administration |
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90 | Dimenhydrinat | Oral administration: various forms |
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91 | Dimethicon (Dimethylpolysiloxan) as a single substance or combined with Guaiazulen | Oral administration: various forms |
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92 | Dimethicon combined with Zinc, Calamin, Cetrimid, etc. in topical products | Topical administration |
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93 | Dimethinden | Oral administration: various forms Topical administration |
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94 | Dinatri Inosin monophosphat | Intravitreal administration |
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95 | Diosmectit (Dioctahedral smectit) | Oral administration: various forms |
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96 | Diosmin combined with Hesperidin and/or some herbal ingredients that contain Flavonoid | Oral administration: various forms |
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97 | Diphenhydramin hydroclorid or monocitrate | Oral administration: various forms with the following concentration limits (bases): - Divided dose: ≤ 50mg/unit; - Undivided dose: ≤ 2.5% |
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98 | Sulfate copper | Topical administration |
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99 | Doxylamin combined with Paracetamol, Pseudoephedrin Hydrochloride, and other active ingredients on OTC drug list in cough medicines, antipyretic drugs, pain relievers | Oral administration: various forms | Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses |
100 | Econazol as a single substance or combined with Hydrocortison | Topical administration: with Hydrocortison concentration (bases) ≤ 0.05% |
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101 | Enoxolon as a single substance or combined with other substances in topical products, lozenges | Topical administration: skin cream, oral mucosa cream, mouthwash Oral administration: lozenges |
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102 | Ephedrin Hydrochlorid | Intravitreal administration, nasal administration: ≤ 1% solution or ≤ 15 ml/pack | Not more than 3 packs (smallest unit) of products that contain Ephedrine may be sold without prescription each time Retailers must record buyers’ names and addresses |
103 | Eprazinon | Oral administration: various forms |
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104 | Esdepallethrin combined with Piperonyl, essential oil, or ingredients of essential oil in topical products | Topical administration |
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105 | Estradiol as a single substance or combined with Dydrogesteron | Oral administration: various forms, divided dose | * Indication: contraception |
106 | Ethanol as a single substance or combined with other substances | Topical administration (antiseptic alcohol) Oral administration: combined with other ingredients |
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107 | Ethylestradiol as a single substance | Oral administration: various forms, divided dose | * Indication: contraception |
108 | Etofenamat | Topical administration |
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109 | Famotidin | Oral administration: divided dose with concentration ≤20mg/unit | Not more than 14 days’ dose of drugs may be sold without prescription |
110 | Fenticonazol | Topical administration |
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111 | Fexofenadin | Oral administration: various forms |
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112 | Flurbiprofen | Lozenges Topical administration Intravitreal administration |
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113 | Glucosamin as a single substance or combined with Chondroitin and/or Vitamins | Oral administration: various forms |
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114 | Glucose or Dextrose as a single substance or combined with sodium or potassium | Oral administration: various forms | Indications: supplementation of sugar or electrolyte |
115 | Glycerin as a single substance or combined with Polysorbat 80 in topical products or eye drops | Topical administration Intravitreal administration |
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116 | Glycerol combined with herbal extracts | Enema |
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117 | Guaiphenesin as a single substance or combined with other ingredients on OTC drug list in cough medicines, antipyretic drugs, pain relievers | Oral administration: various forms | Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses |
118 | Hexamidin as a single substance or combined with Cetrimid, Lidocain, Clotrimazol or Catalase | Topical administration |
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119 | Hexetidin as a single substance or combined with Benzydamin, Cetylpyridinum, Cholin Salicylat, Methyl salicylat, essential oil, etc. | Topical administration: skin cream, mouthwash |
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120 | Hydrocortison as a single substance or combined with Miconazol, Econazol, Tioconazol, Neomycin | Topical administration: various forms with concentration of Hydrocortison ≤ 0.5% |
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121 | Hydrogen Peroxid as a single substance or combined with Sodium Lauryl sulfat and/or essential oil, etc. | Topical administration |
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122 | Hydrotalcit | Oral administration: various forms |
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123 | Hyoscine (Scopolamin) butylbromid as a single substance or combined with Meclizin hydrochlorid | Oral administration: various forms, including chewable tablets Concentration ≤ 20mg/ divided dose Transdermal patch |
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124 | Hydroxypropyl methylcellulose (Hypromellose, HPMC) as a single substance or combined with Dextran 70 and/or Carbomer | Intravitreal administration: various forms |
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125 | Ibuprofen | Oral administration: verious forms with concentration ≤ 400 mg/divided dose. Topical administration |
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126 | Ichthammol | Topical administration |
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127 | Indomethacin | Topical administration 0.1% eye drops |
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128 | Iodine combined with Potassium Iodide and/or Benzoic Acid and/or Salicylic Acid | Topical administration: Iodine concentration ≤ 5% |
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129 | Isoconazol | Topical administration |
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130 | Isopropyl Methylphenol | Topical administration |
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131 | Zinc oxid, zinc pyrithione, zinc gluconate, zinc undecylenate as a single substance or combined with other ingredients in topical products | Topical administration |
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132 | Sulfate zinc | Topical administration Intravitreal administration |
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133 | Ketoconazol as a single substance or combined with Pirythion Zinc and/or Hydrocortison and/or Trolamin | Topical administration: various forms with concentration of Ketoconazol ≤ 2% |
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134 | Ketoprofen | Topical administration |
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135 | Lactitol | Oral administration: various forms |
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136 | Lactoserum atomisate | Topical administration |
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137 | Lactulose | Oral administration: various forms |
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138 | L-Carnitin as a single substance or combined with Vitamins | Oral administration: various forms |
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139 | Levocetirizin | Oral administration: various forms |
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140 | Levonorgestrel as a single substance or combined with Ethylestradiol | Oral administration: various forms | * Indication: contraception |
141 | Lidocain as a single substance or combined with other substances | Topical administration |
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142 | Lindan(Benhexachlor, 666, Gamma-BHC) as a single substance or combined with Lidocain | Topical administration: Lindan concentration ≤ 1% |
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143 | Loperamid | Oral administration: verious forms with Loperamid concentration ≤ 2mg/divided dose |
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144 | Loratadin as a single substance or combined with Pseudoephedrin Hydrochlorid and/or Paracetamol | Oral administration: various forms with the following concentration limits (bases): - Divided dose: Loratadin ≤ 10mg/unit; - Undivided dose: Loratadin ≤ 0.1% | Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses |
145 | Loxoprofen | Oral administration: various forms |
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146 | Macrogol | Oral administration: various forms Enema |
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147 | Magaldrat as a single substance or combined with compounds of aluminum, magnesium, Alginic Acid (or Alginat salt). | Oral administration: various forms |
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148 | Magnesi including salts or compounds of magnesium | Oral administration: various forms | Indications: supplementation of magnesium, gastric acid neutralization, laxatives. |
149 | Mangiferin | Topical administration |
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150 | Mebendazol | Oral administration: various forms with the following concentration limits: - Divided dose: ≤ 500mg/unit - Undivided dose: ≤ 2% |
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151 | Mebeverin | Oral administration: divided dose: ≤ 200mg/unit |
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152 | Cellulase fongique | Oral administration: various forms |
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153 | Enzymes as a single substance or combined with other substances (including combinations with vitamins) | Oral administration: various forms |
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154 | Menthol combined with other active ingredients such as mixtures of essential oil, Methyl Salycilate, etc. | Oral administration: various forms Topical administration: various forms |
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155 | Mequinol | Topical administration |
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156 | Mequitazin | Oral administration: various forms Topical administration |
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157 | Mercurocrom | Topical administration: ≤ 30ml per pack | Not more than 2 packs may be sold without prescription |
158 | Methyl salicylat combined with essential oil, etc. in lozenges, topical products | Topical administration Transdermal patch Lozenges |
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159 | Metronidazol | Topical administration |
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160 | Miconazol | Topical administration Vaginal cream ≤ 2% |
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161 | Miconazole combined with Hydrocortison | Topical administration Vaginal cream Miconazol ≤2%; Hydrocortison ≤0.05% |
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162 | Minoxidil | Topical administration: various forms with concentration ≤ 5% |
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163 | Mometasone | Nasal administration: ≤ 50 mcg/dose, ≤ 200 doses per box; Topical administration. |
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164 | Mupirocin | Topical administration |
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165 | Myrtol as a single substance or combined with other substances in lozenges | Oral administration: various forms Topical administration |
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166 | Naphazolin as a single substance or combined with Diphenylhydramin and/or Procain in nasally administered drugs | Nasal administration with Naphazolin concentration ≤ 0.05% |
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167 | Naphazolin combined with Pheniramin; Vitamin glycyrhizinat, Dexpanthenol, etc. in eye drops | Intravitreal administration: various forms with Naphazolin concentration ≤ 0.1% |
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168 | Naproxen | Oral administration: verious forms with concentration ≤ 275mg/divided dose |
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169 | Sodium benzoate as a single substance or combined with other substances | Oral administration: various forms |
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170 | Sodium bicacbonate as a single substance or combined with other substances | Oral administration: various forms |
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171 | Sodium carbonate as a single substance or combined with other substances | Oral administration: various forms |
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172 | Sodium Carboxymethylcellulose (Na CMC) | Intravitreal administration |
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173 | Sodium Chloride as a single substance or combined with Potassium Citrate, Sodium citrate, etc. | Oral administration: various forms Topical administration Intravitreal administration, nasal administration with concentration ≤ 0.9% |
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174 | Sodium Docusat | Oral administration: various forms |
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175 | Sodium Fluoride combined with other ingredients | Topical administration: toothpaste, mouthwash |
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176 | Sodium Hyaluronat (Hyaluronic acid) | Topical administration Eye drops with concentration ≤ 0.1% |
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177 | Sodium Monofluorophosphate | Topical administration, including products for cleaning the oral cavity, mucous membrane |
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178 | Sodium Salicylate combined with other ingredients | Oral administration: combined with other ingredients in lozenges Topical administration |
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179 | Neomycin sulfate combined with other ingredients in lozenges (Zinc; Bacitracin; Amylocaine, etc.), topical products | Oral administration: lozenges Topical administration |
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180 | Trace elements: chrome, copper, potassium, magnesium, manganese, zinc, etc. as a single substance or combined with other ingredients, including vitamins | Oral administration: various forms | Indications: supplementation of minerals |
181 | Aluminum, magnesium, calcium, and compounds thereof as a single substance or combined with other ingredients | Oral administration: various forms | Indications: gastric acid neutralization, treatment for gastric and duodenal ulcer |
182 | Nonahydrated Natri Sulfid + Saccharomyces Cerevisiae | Oral administration: various forms Topical administration |
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183 | Noscarpin | Oral administration: various forms |
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184 | Nystatin as a single substance or combined with other substances | Topical administration |
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185 | Omeprazol | Oral administration: concentration ≤ 10 mg/divided dose | Indication: treatment of heartburn Not more than 14 days’ dose of drugs shall be sold only one time without prescription and maximum dose of ≤ 20mg per day |
186 | Orlistat | Oral administration: various forms |
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187 | Ossein hydroxyapatite | Oral administration: various forms |
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188 | Oxeladine | Oral administration: various forms |
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189 | Oxomemazine | Oral administration: various forms |
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190 | Oxymetazoline | Nasal administration with concentration ≤ 0.5% |
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191 | Pancreatin as a single substance or combined with Simethicon and/or enzymes and/or B vitamins and/or Azintamid | Oral administration: various forms | . |
192 | Panthenol | Topical administration Intravitreal administration |
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193 | Paracetamol as a single substance | Oral administration: various forms Rectal suppositories | Combinations of paracetamol with other substances are specified in the list |
194 | Paracetamol combined with active ingredients in this List, meant to treat cough, reduce fever, relief pain, prevent allergy | Oral administration: various forms | Combinations that contain active ingredients that have limited concentrations and may be retailed only once must comply with corresponding regulations applied thereto |
195 | Pentoxyverin | Oral administration: various forms |
|
196 | Phenylephrine Hydrochloride | Intravitreal administration, nasal administration with concentration ≤ 1% |
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197 | Phenylephrine Hydrochloride combined with other ingredients in topical products (such as Petrolatum sperti yellow; Mineral oil light; Shark liver oil, etc.) | Topical administration |
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198 | Phenylephrine Hydrochloride combined with other ingredients in cough medicines, antipyretic drugs, pain relievers | Oral administration: various forms Rectal suppositories |
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199 | Phospholipid | Oral administration: various forms |
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200 | Picloxydin | Intravitreal administration |
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201 | Piroxicam | Topical administration: various forms with concentration ≤ 1% |
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202 | Policresulen (Metacresolsulphonic acid-formaldehyd) | Topical administration Rectal suppositories |
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203 | Polyethylen glycol 400 as a single substance or combined with Propylene glycol | Intravitreal administration | . |
204 | Polysacharid | Oral administration: various forms |
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205 | Polytar as a single substance or combined with other ingredients in topical products (Zinc Pyrithion, etc.) | Topical administration |
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206 | Povidon Iodin | Topical administration: various forms (including mouthwash with concentration ≤ 1%). Intravitreal administration |
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207 | Promethazin Hydrochloride as a single substance or combined with Carbocystein, Paracetamol, etc. in cough medicines, antipyretic drugs, pain relievers | Oral administration: various forms with the following Promethazin concentration limits (bases): - Divided dose: ≤ 12.5mg/unit; - Undivided dose: ≤ 0.1% Topical administration: concentration ≤ 2% |
|
208 | Pseudoephedrin Hydrochloride combined Cetirizine | Oral administration: various forms with the following Pseudoephedrin concentration limits (bases): - Divided dose: ≤ 120mg/unit; - Undivided dose: ≤ 0.5% | Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses |
209 | Phenylephrine Hydrochloride combined with other ingredients in cough medicines, antipyretic drugs, pain relievers and anti-allergy medication | Oral administration: various forms with the following Pseudoephedrin concentration limits (bases): - Divided dose: ≤ 120mg/unit; - Undivided dose: ≤ 0.5% | Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses |
210 | Pyrantel | Oral administration: various forms | Indication: vermifuge |
211 | Ranitidin | Oral administration: various forms, with concentration ≤ 75mg/divided dose | Not more than 15 days’ dose of drugs may be sold without prescription. Indication: treatment of hearburn |
212 | Rutin as a single substance or combined with Vitamin C and/or herbal extracts | Oral administration: various forms |
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213 | Saccharomyces boulardic | Oral administration: various forms |
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214 | Saccharomyces cerevisiae combined with Trihydrat Magnesi Sulfat | Oral administration: various forms |
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215 | Iron compounds as a single substance or combined with vitamins or minerals | Oral administration: various forms | Indications: supplementation of iron. |
216 | Organic selenium combined with vitamins or minerals | Oral administration: various forms with the following concentration limits: - Divided dose of selenium: ≤ 50mcg/unit |
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217 | Selenium sulfide | Topical administration |
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218 | Silymarin as a single substance or combined with Vitamin and/or herbal ingredients | Oral administration: various forms |
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219 | Simethicon as a single substance or combined with Pancreatin and/or Desoxycholic Acid and/or B vitamins and/or enzymes | Oral administration: various forms |
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220 | Simethicon combined with aluminum compounds, magnesium, and/or Dicyclomine and/or activated carbon | Oral administration: various forms |
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221 | Sorbitol as a single substance or combined with other substances | Oral administration: various forms |
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222 | Sterculia (gum sterculia) | Oral administration: various forms Enema |
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223 | Sucralfate | Oral administration: various forms |
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224 | Sulbutiamine | Oral administration: various forms |
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225 | Sulfoguaiacol as a single substance or combined with other ingredients in cough medicines, antipyretic drugs, pain relievers | Oral administration: various forms |
|
226 | Terbinafine | Topical administration: various forms with concentration ≤ 1% |
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227 | Terpin as a single substance or combined with Codeine | Oral administration: various forms Combined Codein with the following concentration limits (bases): - Divided dose: ≤ 12mg/unit; - Undivided dose: ≤ 2.5% | Not more than 10 days’ dose of products that contain Codein may be sold without prescription Retailers must record buyers’ names and addresses |
228 | Tetrahydrozoline | Nsal administration |
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229 | Activated carbon as a single substance or combined with Simethicone | Oral administration: various forms |
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230 | Essential oil (including Menthol, Pinen, Camphor, Cineol, Fenchone, Borneol, Anethol, Eucalyptol, etc.) | Oral administration: various forms Topical administration: skin cream Mouthwash, oral mucosa cream |
|
231 | Tioconazol as a single substance or combined with Hydrocortison | Topical administration: various forms with the following concentration limits: - Tioconazol ≤ 1.00% - Hydrocortison ≤ 0.05% |
|
232 | Tolnaftate | Topical administration |
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233 | Triclosan as a single substance or combined with other ingredients in topical products | Topical administration |
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234 | Triprolidin as a single substance or combined with other ingredients in cough medicines, antipyretic drugs, pain relievers. | Oral administration: various forms | Not more than 15 days’ dose of products that contain Pseudoephedrin may be sold without prescription Retailers must record buyers’ names and addresses |
235 | Trolamin as a single substance or combined with other ingredients (with Triclosan and/or Tyrothricin) in topical products | Topical administration |
|
236 | Tyrothricin as a single substance or combined with Benzalkonium, Benzocain, Formaldehyd, Trolamin, essential oil, ingredients in essential oil | Oral administration: lozenges Topical administration: mouthwash, mouth spray, skin cream |
|
237 | Urea as a single substance or combined with Vitamin E and/or Bifonazol and/or herbal ingredients that are not mentioned on the list of toxic herbal ingredients | Topical administration |
|
238 | Vitamin A and provitamin A (Betacarotene) as a single substance or combined with vitamins | Oral administration: various forms with Vitamin A concentration ≤ 5000 IU/unit Topical administration Intravitreal administration |
|
239 | Vitamin as a single substance (except Vitamin D) or combined with other Vitamins, minerals, amino acids, fatty acids, Taurine, Lutein, Zeaxanthin | Oral administration: various forms Topical administration Oral administration: various forms with the following Vitamin A concentration limits: Vitamin A ≤ 5000 IU/divided unit | Indication: supplementation of vitamins, minerals and nutrients |
240 | B vitamins, vitamin PP as a single substance or combined with other ingredients | Intravitreal administration |
|
241 | Bacteria beneficial to the gastrointestinal tract: Bacillus claussi, Bacillus subtilis, Lactobacillus acidophilus including those combined with vitamins | Oral administration: various forms |
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242 | Methylene blue | Topical administration |
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243 | Xylometazolin as a single substance or combined with Benzalkonium. | Nsal administration with Xylometazolin concentration ≤ 1% |
|
* With regard to contraception drugs on this List, drug retailers who are bachelors of pharmacy or persons in charge of pharmacy expertise of drug retailers are responsible for providing and giving instructions about drug-related information, including: the drug name, effects, indications, contraindications, dosage, route of administration, and notes for using drugs before providing or selling drugs to buyers.
II. OTC HERBAL DRUGS, TRADITIONAL DRUGS (EXCEPT TRADITIONAL INGREDIENTS)
Herbal drugs, traditional drugs (except traditional ingredients) which meet all of the following criteria shall be classified as OTC drugs:
1. Do not contain herbal ingredients on the List of toxic herbal ingredients announced by Minister of Health.
2. Do not have any of the following indications:
a) Use as supportive drugs or for treatment of cancer or tumour;
b) Treatment of cardiovascular diseases or blood pressure diseases;
c) Treatment of liver, biliary or pancreas diseases (excluding liver tonics);
d) Treatment of Parkinson disease;
dd) Treatment of viral infection;
e) Treatment of fungal infections (excluding topical antifungal medications);
g) Treatment of tuberculosis;
h) Treatment of malaria;
i) Treatment of gout;
k) Treatment of asthma;
l) Treatment of endocrine diseases;
m) Treatment of blood disorders or diseases;
n) Treatment of blood disorders or diseases;
o) Treatment of kidney and genitourinary system diseases (excluding kidney yang tonics);
p) Treatment of bacterial contamination diseases (excluding topical antibiotics);
q) Treatment of chronic insomnia;
r) Treatment of psychological disorders and mental illness;
s) Drug abuse treatment or supportive drugs for addiction treatment (including supportive drugs for detoxification);
t) Interruption of pregnancy;
u) Treatment of dangerous and emerging infectious diseases as regulated by Minister of Health.
III. OTC TRADITIONAL INGREDIENTS
Traditional ingredients that are not manufactured or made of herbal ingredients on the List of toxic herbal ingredients announced by Minister of Health shall be classified as OTC (non-prescription) drugs.
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