Thông tư 42/2010/TT-BYT

Circular No. 42/2010/TT-BYT of December 15, 2010 promulgating the list of pharmaceutical active substances and medicinal herbs permitted to be registered for advertisement on radio and television

Circular No. 42/2010/TT-BYT promulgating the list of pharmaceutical đã được thay thế bởi Circular No. 09/2015/TT-BYT stipulating the approval for contents of advertisements for special products và được áp dụng kể từ ngày 16/07/2015.

Nội dung toàn văn Circular No. 42/2010/TT-BYT promulgating the list of pharmaceutical


THE MINISTRY OF HEALTH
-------

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom – Happiness
---------

No. 42/2010/TT-BYT

Hanoi, December 15, 2010

 

CIRCULAR

PROMULGATING THE LIST OF PHARMACEUTICAL ACTIVE SUBSTANCES AND MEDICINAL HERBS PERMITTED TO BE REGISTERED FOR ADVERTISEMENT ON RADIO AND TELEVISION

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

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

The Ministry of Health issues and guides to implement “The list of pharmaceutical active substances and medicinal herbs permitted to be registered for advertisement on radio and television” as follows:

Article 1. Issue together with this Circular “The list of pharmaceutical active substances and medicinal herbs permitted to be registered for advertisement on radio and television, including:

1. The List of pharmaceutical active substances;

2. Regulations for medicinal herbs

Article 2. Interpretation of terms

1. Pharmaceutical active substances (also known as drugs) means: a substance or a mixture of substances which is active in treatment used for drug production

2. Drugs derived from medicinal plants mean: drug is produced from raw materials derived from nature of animal, vegetable or mineral.

Drugs with pure active substances extracted from medicinal herbs, drugs with combination of medicinal herbs and synthetic chemical active substances are not called drugs from medicinal herbs

Article 3. The principle to set up list:

1. List of pharmaceutical active substances and medicinal herbs permitted to be registered for advertisement on radio and television is set up on basis of no prescription drug list and specific criterions on pharmacological properties and safety of drug.

2. List of pharmaceutical active substances and medicinal herbs permitted to be registered for advertising on radio and television in accordance with actual of Vietnam's drug using, supplying and consistent with regulations on current drug advertisement information.

3. List of pharmaceutical active substances and medicinal herbs permitted to be registered for advertising on radio and television will be amended and supplemented in accordance with list of no-prescription in case where list of prescription is changed. When it is necessary, to ensure safety for user, some drugs that can be removed from list of active substances and medicinal herbs permitted to be registered for advertising on radio and television if there are detected seriously harmful effects.

Article 4. Selective criteria for pharmaceutical active substances

1. On the list of drugs without writing a prescription issued by the Ministry of Health are still valid.

2. Pharmaceutical active substance meets criteria of list of drugs without writing a prescription but it will not be selected if it includes at least one of the following characteristics:

- Topical, stay-in effect but are likely not control the amount of drug absorbed through skin.

- Appointed in treatment of common diseases, but these diseases include symptoms that easily confused with disease need to be a doctor’s visit.

- Having using dose / regimen / duration should be strictly obeyed if not, shall happen status of drug resistance.

-Safe to use short term but may be at risk in case of prolonged use.

Article 5. Application to list

List of pharmaceutical active substances and medicinal herbs permitted to be advertised on radio and television is one of the legal bases for registration, consideration of drug advertising dossier on radio and television.

Article 6. Provisions for implementation

1. This Circular takes effect 45 days after date of its signing. To annul the Decision No. 45/2007/QD-BYT of December 18, 2007 of the Minister of Health on promulgating list of pharmaceutical active elements and drugs registered for advertising on radio and television.

2. The content of drug advertisement on radio and television that had the receipt of advertisement registration dossier by the Department of Drug Administration before the effective date of this Circular will be continued advertising until the content of that drug advertisement unvalued.

3. Department of Drug Administration, units under the Ministry of Health, Departments of Health of provinces and cities directly under Central Government, Vietnam Pharmaceutical Corporation, pharmaceutical business-manufacturing enterprises, foreign company licensed activities in line of pharmacy is responsible for implementation of this Circular.

4. In the process of implementation, if problems arising to propose organizations and individuals to promptly inform to the Ministry of Health (Department of Drug Administration) for consideration and settlement. /.

 

 

ON BEHALF OF MINISTER
VICE MINISTER




Cao Minh Quang

 

LIST

DRUGS AND HERBAL INGREDIENTS ALLOWED TO BE ADVERTISED ON RADIO AND TELEVISION
(Promulgated together with the Circular No. 42/2010/TT-BYT dated December 17, 2010)

1. List of drugs:

No.

Active ingredients

Routes of administration, dosage forms, dose and concentration limits

Notes

1

Acetylcystein

Oral: various forms

 

2

Acetylleucine

Oral administration: various forms

 

3

Acetylsalicylic acid (aspirin), isolated or combined 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), isolated or in combination with compounds of aluminum or magnesium.

Oral administration: various forms

 

5

Amino acid, isolated or in combinations (including combination with vitamins, minerals, trace elements)

Oral administration: various forms  

Indications: provide supplemental amino acids and vitamins for the body.

6

Aminobenzoic acid (para-aminobenzoic acid)

Oral administration: various forms

 

7

Benzoic acids, isolated or in combinations

Topical administration  

Oral administration: lozenges

 

8

Boric acid, isolated or in combinations

Topical administration

Eye drops

 

9

Citric acid in combination with sodium or potassium salts

Oral administration: various forms

 

10

Cromoglicic acid and cromoglycates

Eye drops and nose drops with cromoglicic acid ≤ 2%

 

11

Dimecrotic acid

Oral administration: various forms

 

12

Folic acid, isolated or in combination with iron and/or B vitamins, minerals, sorbitol

Oral administration: various forms

Indications: prevention of anemia, nutritional supplements

13

Glycyrrhizinic acid (Glycyrrhizinate) in combination with other substances such as Chlorpheniramine maleate, Dl-methylephedrine, caffeine, etc.

Oral administration: various forms, including lozenges

Topical administration

 

14

Mefanamic acid

Oral administration: various forms

 

15

Salicylic acid, isolated or in combinations in topical products (in combination with lactic acid, precipitated sulfur

Topical administration

 

16

Albendazole

Oral administration: various forms

Indications: deworming

17

Dichlorbenzyl alcohol, in combinations in lozenges

Oral administration: lozenge

 

18

Polyvinyl alcohol

Topical administration

 

19

Alimemazine tartrate (Trimeprazine tartrate)

Oral administration: various forms

 

20

Allantoin, in combinations in topical products (Cepae fluid; Heparin, etc.)

Topical administration

 

21

Allatoin in combination with vitamins and/or Chondroitin

Eye drops

 

22

Almagate

Oral administration: various forms

 

23

Ambroxol, isolated or in combinations in cough medicine, antipyretics, painkillers

Oral administration: various forms with limited concentrations of active ingredients:

- Divided dose: Ambroxol chlorhydrate ≤ 30 mg/unit

- Undivided dose: Ambroxol chlorhydrate ≤ 0.8%

 

24

Amyllase, isolated or in combination with Protease and/or Cellulase

Oral administration: various forms

 

25

Amylmetacresol, in combinations in lozenges (such as with essential oil, bacitracine, etc.)

Oral administration: lozenges

 

26

Argyrol

Eye drops

Topical administration

 

27

Aspartame

Oral administration: various forms

 

28

Aspartate

Oral administration: various forms

 

29

Attapulgite

Oral administration: various forms

 

30

Azelastine

Eye drops, nose drops

 

31

Silver sulfadiazine

Topical administration

 

32

Bacillus clausii

Oral administration: various forms

 

33

Lyophilized bacillus subtilis

Oral administration: various forms with the following limits:

 

34

Bacitracin in combination with other drugs in lozenges (with neomycin sulfate, Amylocaine, Tixocortol, etc.)

Oral administration: lozenges

.

35

Benzalkonium, in combinations in topical products (with choline; salicylic acid; nystatin: Diiodohydroxyquinoline, etc.) in lozenges (with tyrothricine, bacitracin, essential oil, etc.)

Topical administration

Oral administration: lozenges

 

36

Benzocaine, in combinations

Topical administration: various forms with Benzocaine ≤ 10%;

Oral administration: lozenges

 

37

Benzoyl peroxide, isolated or in combination with iodine and/or sulfur

Topical administration: various forms with concentration ≤ 10%

 

38

Benzydamine HCl, isolated or in combinations

Topical administration: oral mucosa ointment, mouthwash, oral sprays

Oral administration: lozenge

 

39

Benzydamine salicylate, isolated or in combinations

Oral administration: lozenge

 

40

Benzyl benzoate, in combinations in topical products (essential oil, Isopropyl, etc.)

Oral administration: various forms

Transdermal patches

 

41

Berberine

Oral administration: various forms

 

42

Biclotymol, isolated or in combination with Enoxolon and/or Phenylephrine HCl and/or Chlorpheniramine maleate and/or essential oil

Oral administration: lozenge

Nose drops

Oral administration: lozenges

 

43

Bifonazole, isolated or in combination with urea

Oral administration: lozenge

 

44

Bisacodyl

Oral administration: various forms with concentrations of doses ≤ 10mg/unit

 

45

Boldin

Oral administration: various forms

 

46

Bromelain, isolated or in combination with Trypsin

Oral administration: various forms with the following limits:

 

47

Bromhexin HCl, isolated or in combination with cough medicines, antipyretics, painkillers (such as with Dextromethorphan HBr, Diphenhydramin, Guaiphenesin, etc.)

Oral administration: various forms with limited concentrations of Bromhexine HCl:

- Divided dose: ≤ 8 mg/unit;

- Undivided dose: ≤ 0.8%

Rectal suppositories

 

48

Brompheniramine maleate, isolated or in combinations in cough medicine, antipyretics, painkillers

Oral administration: various forms with the following limits:

 

49

Bufexamac, isolated or in combinations in topical products and rectal suppositories (such as with Titan Dioxid, Bismuth, Subgallat, Lidocain, etc.)

Oral administration: lozenge

Rectal suppositories

 

50

Butoconazol

Topical administration

 

51

Compounds of calcium (except for Calcitriol), isolated or in combination with Vitamin D and/or vitamins and/or Ipriflavon

Oral administration: various forms

Indications: providing supplemental calcium for the body

52

Compounds of aluminum, magnesium, calcium , isolated and in combinations

Oral administration: various forms

Indications: neutralizing gastric acid, treating duodenal and gastric ulcer and

53

Compounds of iron and/or in combination with folic acid, vitamin B12, ect.

Oral administration: various forms

Indications: preventing and treating anemia

54

Enzymes, isolated or in combination with vitamins

Oral administration: various forms

 

55

Bismuth salts

Oral administration: various forms

 

56

Magnesium salts

Oral administration: various forms

Indications: providing supplemental magnesium for the body, neutralizing gastric acid.

57

trace elements: chromium, copper, potassium, magnesium, manganese, sodium, etc.

Oral administration: various forms

Indications: providing supplemental minerals for the body, including combinations with vitamins.

58

Essential oils (Menthol, Pinene, Camphor; Cineol, Fenchone, Borneol, Anethol, Eucalyptol...)

Oral administration: various forms

Topical administration: topical ointment, mouthwash, oral mucosa ointment

 

59

Calamine, isolated or in combinations in topical products

Topical administration

 

60

Carbinoxamine, isolated or in combination with cough medicines, antipyretics, painkillers (with Pseudoephedrine HCl and/or Bromhexin and/or Paracetamol)

Oral administration: various forms with limited concentrations of Pseudoephedrine (in base form):

- Divided dose: ≤ 120 mg/unit;

- Undivided dose: ≤ 0.5%

 

61

Carbocystein

Oral administration: various forms

 

62

Carbomer

Topical administration

Eye drops

 

63

Catalase, isolated or in combinations in topical products (with Neomycin)

Topical administration

 

64

Cetirizine dihydrocloride

Oral administration: various forms

 

65

Cetrimide in combination with other substances in topical products (Lidocain, zinc, Calamine, Aminacrine, essential oil etc.)

Topical administration

 

66

Cetrimonium, in combinations in topical products and lozenges (in combination with Lidocain; Tyrothricin, essential oil, etc.)

Topical administration

Oral administration: lozenges

 

67

Chitosan (Polyglusam)

Topical administration

 

68

Choline, isolated or in combination with amino acids and vitamins in orally administered products; in combination with salicylic acids, benzalkonium, etc. in topical products

Oral administration: various forms

Topical administration

 

69

Chondroitin, isolated or in combination with glucosamine and/or fish oil and/or vitamins and/or amino acids

Oral administration: various forms

 

 

70

Chondroitin in combination with vitamins

Nose drops with a concentration ≤ 0.5%

 

71

Chondroitin, in combinations in topical products

Oral administration: lozenge

 

72

Ciclopirox olamin

Topical administration

 

73

Cinnarizin

Oral administration: various forms

 

74

Cinchocain, in combinations in topical products (such with hydrocortison,  neomycin, esculin, etc.)

Topical administration

 

75

Citrulline

Oral administration: various forms

 

76

Chlorhexidine

Topical administration

 

77

Chlorophyll

Oral administration: various forms

 

78

Chlorpheniramine maleate, isolated or in combination with cough medicines, antipyretics, painkillers (with Phenylephrine HCl, Paracetamol, Dextromethorphan HBr, etc.)

Oral administration: various forms.

Divided-dose isolated substance: Chlorpheniramine maleate < 4mg/unit.

 

79

Chlorpheniramine maleate in combination with chondroitin and/or vitamins

Eye drops

 

80

Chlotrimazole

Topical administration: various forms with concentration ≤ 3%

 

81

Coenzym Q10, isolated or in combination with vitamins

Oral administration: various forms

 

82

Crotamiton

Topical administration

 

83

Copper sulfate

Topical administration

 

84

Dequalinium, isolated or in combinations in topical products and lozenges (Tyrothricin; hydrocortison; Glycyrrhetinic acid; Lidocain...), etc.)

Topical administration

Oral administration: lozenges

 

85

Dexbrompheniramine maleate, isolated or in combinations in cough medicine, antipyretics, painkillers

Oral administration: various forms

 

86

Dexchlorpheniramine maleate, isolated or in combinations in cough medicine, antipyretics, painkillers

Oral administration: various forms

 

87

Dexibuprofen

Oral administration: various forms

 

88

Dexpanthenol

Eye drops

Topical administration

 

89

Dextromethorphan HBr, isolated or in combinations in cough medicine, antipyretics, painkillers

Oral administration: various forms with the limited concentrations (in base form):

- Divided dose: Dextromethophan ≤ 15mg

- Undivided dose: Dextromethophan ≤ 0.6%

.

90

Diclofenac, isolated or in combination with methyl salicylate, essential oil, etc.

Topical administration

Eye drops (isolated substances)

 

91

Dicyclomine

Oral administration: various forms

 

92

Diethylphtalate (DEP)

Topical administration

 

93

Dimenhydrinate

Oral administration: various forms

 

94

Dimethicone (Dimethylpolysiloxane), isolated or in combination with Guaiazulene

Oral administration: various forms

 

95

Dimethicone, in combinations in topical products (with zinc, calamine, cetrimide, etc.)

Topical administration

 

96

Dimetinden

Oral administration: various forms

Topical administration

 

97

Disodium inosine monophosphate

Eye drops

 

98

Diosmectite (Dioctahedral smectite)

Oral administration: various forms

 

99

Diosmin in combination with hesperidin and/or some medicinal herbals that contain flavonoid

Oral administration: various forms

 

100

Diphenhydramine hydrochloride or monocitrate

Oral administration: various forms with limited concentrations (in base form):

- Divided dose: ≤ 50 mg/unit;

- Undivided dose: ≤ 2.5%

 

101

Domperidon

Oral administration: various forms with limited concentrations:

- Divided dose: ≤ 10 mg/unit;

- Undivided dose: ≤ 0.1%

 

102

Doxylamine, in combinations in cough medicines, antipyretics, painkillers (similarly to Paracetamol; Pseudoephedrine HCl; Dextromethorphan HBr; Vitamins, etc.

Oral administration: various forms with limited concentration of Pseudoephedrine (in base form):

- Divided dose: ≤ 120 mg/unit;

- Undivided dose: ≤ 0.5%

 

103

 Econazole

Topical administration

 

104

Enoxolone, isolated or in combinations in topical products and lozenges

Topical administration: topical ointment, mouthwash, oral mucosa ointment

Oral administration: lozenges

 

105

Eprazinon

Oral administration: various forms

 

106

Esdepallethrin, in combinations in topical products (with essential oil, piperonyl, etc.)

Topical administration

 

107

Ethanol, isolated or in combinations

Topical administration (antiseptic alcohol)

Oral administration: combinations

 

108

Etofenamate

Topical administration

 

109

Fenticonazole

Topical administration

 

110

Fexofenadine

Oral administration: various forms

 

111

Flurbiprofen

Lozenges

Topical administration

Eye drops

 

112

Glucosamine, isolated or in combination with Chondroitin and/or Vitamins

Oral administration: various forms

 

113

Glucose or dextrose, isolated or in combination with sodium or potassium salts

Oral administration: various forms

Indications: providing supplemental sugar and electrolytes

114

Glycerinw, isolated or in combinations in topical products and eye drops (with Polysorbate 80)

Oral administration: lozenge

Nose drops with a concentration ≤ 0.5%

 

115

Glycerol, isolated or in combination with herbal extract.

Rectal enema

 

116

Guaiphenesin, isolated or in combinations in cough medicines, antipyretics, painkillers (with Paracetamol, Pseudoephedrine HCl, Dextromethorphan HBr, etc.

Oral administration: various forms with limited concentration of Pseudoephedrine (in base form):

- Divided dose: ≤ 120 mg/unit;

- Undivided dose: ≤ 0.5%

 

117

Hexamidine, isolated or in combinations (with Cetrimide, Lidocain, Clotrimazole, Catalase)

Oral administration: lozenge

 

118

Hexetidine, isolated or in combinations (with Benzydamin, Cetylpyridinum, Choline Salicylat, Methyl salicylate, essential oil, etc.)

Topical administration: topical ointment, mouthwash

 

119

Hydrocortison, isolated or in combinations (with Miconazole, Econazole, Tioconazole, Neomycin)

Topical administration: various forms with hydrocortisone ≤ 0.5%

 

120

Hydrogen peroxide, isolated or in combination with sodium lauryl sulfat and/or essential oil, etc.

Oral administration: lozenge

 

121

Hydrotalcit

Oral administration: various forms

 

122

Hydroxypropyl methylcellulose (HPMC)

Eye drops

 

123

Hypromellose, isolated or in combination with Dextran 70

Eye drops: various forms

 

124

Ibuprofen

Oral administration: various forms

Topical administration

 

125

Ichthammol

Topical administration

 

126

Iodine, isolated or in combination with benzoic acid and/or salicylic acid

Topical administration with iodine ≤ 5%

 

127

Isoconazole

Topical administration

 

128

Isopropyl Methylphenol

Topical administration

 

129

Ketoconazole, isolated or in combination with zinc pirythione and/or hydrocortison and/or trolamine

Topical administration: various forms with Ketoconazole ≤ 2%

 

130

Ketoprofen

Topical administration

 

131

Zinc oxide, zinc pyrithione, zinc gluconate, zinc undecylenate, isolated or in combination with topical products

Topical administration

 

132

Zinc sulfat

Topical administration

Eye drops

 

133

Lactic acid bacillus, isolated or in combination with vitamins

Oral administration: various forms

 

134

Lactitol

Oral administration: various forms

 

135

Lactobacillus acidophilus

Oral administration: various forms

 

136

Lactobacillus acidophilus, isolated or in combination with vitamins

Oral administration: various forms

 

137

Lactoserum atomisate (Lactacyd)

Topical administration

 

138

Lactulose

Oral administration: various forms

 

139

Levocetirizine

Oral administration: various forms

 

140

Lindan (Benhexachlor, 666, Gamma-BHC), isolated or in combination with lidocain

Topical administration with Lindan ≤ 1%

 

141

Loratadine, isolated

Oral administration: various forms with the following limited concentration (in base form):

- Divided dose:

Loratadine ≤ 10mg/unit;

- Undivided dose:

Loratadine ≤ 0.1%

 

142

Loxoprofen

Oral administration: various forms

 

143

Lysozyme, isolated or in combination with Tocopherol, Nicotinate, Carbazochrome, Inositol Cetylpyridinium, etc.

Oral administration: various forms

Topical administration

 

 

144

Macrogol

Oral administration: various forms

Rectal enema

 

145

Magaldrate, isolated or in combination with aluminum, magnesium, alginic acid (or alginate salts)

Oral administration: various forms

 

146

Mangiferin

Topical administration

 

147

Mebendazole

Oral administration: various forms with limited concentrations:

- Divided dose: ≤ 500 mg/unit

- Undivided dose: ≤ 2%

 

148

Cellulase fongique

Oral administration: various forms

 

149

Menthol in combination with other substances such as essential oil mixture, methyl salicylate, etc.

Oral administration: various forms

Topical administration: various forms

 

150

Mequinol

Topical administration

 

151

Mequitazine

Oral administration: various forms

Topical administration

 

152

Methyl salicylate, in combinations in topical products (in combination with essential oil, etc.)

Topical administration

Transdermal patches

Oral administration: lozenges

 

153

Metronidazole

Topical administration

 

154

Miconazole

Topical administration

Vaginal cream ≤ 2%

 

155

Minoxidil

Topical administration: various forms with concentration ≤ 5%

 

156

Mupirocin

Topical administration

 

157

Myrtol, isolated or in combinations in lozenges

Oral administration: various forms

Topical administration

 

158

Naphazoline, in combinations in eye drops, (Pheniramine; Vitamin glycyrhizinate, Dexpanthenol, etc.)

Eye drops: various forms with Naphazoline ≤ 0.1%

 

159

Naproxen

Oral administration: various forms with divided-dose Naproxen ≤ 250mg/unit

 

160

Sodium benzoate, isolated or in combinations

Oral administration: various forms

 

161

Sodium bicarbonate, isolated or in combinations

Oral administration: various forms

 

162

Sodium carbonate, isolated or in combinations

Oral administration: various forms

 

163

Sodium Carboxymethylcellulose (Na CMC)

Eye drops

 

164

Sodium chloride, isolated or in combination with potassium citrate, sodium citrate, etc.

Oral administration: various forms

Topical administration

Eye drops, nose drops

 

165

Sodium docusate

Oral administration: various forms

 

166

Sodium fluoride, in combinations

Topical administration: toothpaste, mouthwash

 

167

Sodium hyaluronate (Hyaluronic acid)

Topical administration

 

168

Sodium monofluorophosphate

Topical administration: toothpaste, mouthwash

 

169

Sodium salicylate, in combinations

Oral administration: in combinations in lozenges

Topical administration

 

170

Neomycin sulfate, in combinations in lozenges (zinc, bacitracin, amylocaine, etc.) and topical products

Oral administration: lozenges

Topical administration

 

171

Nomahydrated sodium Sulfide + Saccharomyces Cerevisiae

Oral administration: various forms

Topical administration

 

172

Nystatin, isolated or in combinations

Topical administration

 

173

Ossein hydroxyapatite

Oral administration: various forms

 

174

Oxeladin

Oral administration: various forms

 

175

Oxymemazine

Oral administration: various forms

 

176

Oxymetazoline

Nose drops with a concentration ≤ 0.5%

 

177

Pancreatin, isolated or in combination with Simethicone and/or enzymes and/or B vitamins and/or Azintamide

Oral administration: various forms

.

178

Panthenol

Topical administration

Eye drops

 

179

Paracetamol

Oral administration: various forms

Rectal suppositories

In combinations specified in the list

180

Paracetamol in combination with Ibuprofen and/or Caffeine

Oral administration: various forms

 

181

Paracetamol in combination with Loratadine and/or Dextromethorphan HBr

Oral administration: various forms

 

182

Paracetamol in combination with Pseudoephedrine HCl and/or vitamin C and/or one of the substances below:

Brompheniramine maleate; Chlorpheniramine maleate; Pheniramine maleate; Dexclorpheniramine maleate; Dexbrompheniramin maleate;

Dextromethorphan HBr;

Phenylephrine HCl

Oral administration: various forms with limited concentrations (in base form):

- Divided dose: Pseudoephedrine ≤ 120 mg/unit

Dextromethophan ≤ 15mg/unit

- Undivided dose: Pseudoephedrine ≤ 0.5%

Dextromethophan ≤ 0.6%

 

183

Pentoxyverine

Oral administration: various forms

 

184

Phenylephrine HCl, in combinations in topical products (such as Petrolatum sperti yellow; Mineral oil light; Shark liver oil, etc.)

Topical administration

.

185

Phenylephrine HCl in combination with cough medicines, antipyretics, and painkillers

Oral administration: various forms

Rectal suppositories

 

186

Phospholipid

Oral administration: various forms

 

187

Picloxydin

Eye drops

 

188

Piroxicam

Topical administration: various forms with concentration ≤ 1%

 

189

Policresulen (Metacresol sulphonic acid-formaldehyde)

Topical administration

Rectal suppositories

 

190

Polymethylene glycol 400, isolated or in combination with propylene glycol

Eye drops

 

191

Polysaccharide

Oral administration: various forms

 

192

Polytar, isolated or in combinations in topical products (such as zinc pyrithione, etc.)

Topical administration

 

 

193

Povidone Iodine

Topical administration: various forms, including mouthwash ≤ 1% Eye drops

 

194

Pseudoephedrine HCl in combination with Cetirizin

Oral administration: various forms with limited concentrations of Pseudoephedrine (in base form):

- Divided dose: ≤ 120 mg/unit

- Undivided dose: ≤ 0.5%

 

195

Phenylephrine HCl, in combinations in cough medicines, antipyretics, and painkillers

Oral administration: various forms with limited concentrations of Pseudoephedrine (in base form):

- Divided dose: ≤ 120 mg/unit;

- Undivided dose: ≤ 0.5%

 

196

Pyrantel

Oral administration: various forms

Indications: deworming

197

Rutin, isolated or in combination with vitamin C and/or herbal extract

Oral administration: various forms

 

198

Saccharomyces boulardic

Oral administration: various forms

 

199

Saccharomyces cerevisiae + Magnesium sulfate trihydrate

Oral administration: various forms

 

 

Organic selenium, in combinations in products that contain vitamins and minerals

Oral administration: various forms with limited concentrations:

- Divided dose: selenium ≤ 120 mcg/unit

 

200

Selenium sulfide

Topical administration

 

201

Silymarin, isolated or in combination with vitamins and/or herbal extract

Oral administration: various forms

 

202

Simethicone, isolated or in combination with pancreatin and/or deoxycholic acid and/or B vitamins and/or enzymes

Oral administration: various forms

 

203

Simethicone in combination with compounds of aluminum, magnesium, and/or dicyclomine and activated carbon

Oral administration: various forms

 

204

Sorbitol, isolated or in combinations

Oral administration: various forms

 

205

Sterculia (gum sterculia)

Oral administration: various forms

Rectal enema

 

206

Sucralfate

Oral administration: various forms

 

207

Sulbutiamine

Oral administration: various forms

 

208

Sulfogaiacol, isolated or in combinations in cough medicines, antipyretics, painkillers (such as in combination with sodium benzoate, dextromethophan, etc.)

Oral administration: various forms

 

209

Terbinafin

Topical administration: various forms with concentration ≤ 1%

 

210

Terpin, isolated

Oral administration: various forms.

 

211

Tetrahydrozoline

Nose drops

 

212

Activated carbon, isolated or in combination with simethicone

Oral administration: various forms

 

213

Tioconazole, isolated or in combination with hydrocortison

Topical administration: various forms with limited concentrations:

- Tioconazole ≤ 1.00%

- Hydrocortison ≤ 0.05%

 

214

Tolnaftate

Topical administration

 

215

Triclosan, isolated or in combinations in topical products

Topical administration

 

216

Triprolidine, isolated or in combinations in cough medicines, antipyretics, painkillers (such as with guaiphenesine, paracetamol, pseudoephedrine HCl, dextromethorphan HBr, etc.)

Oral administration: various forms with limited concentrations of Pseudoephedrine (in base form):

- Divided dose: ≤ 120 mg/unit;

- Undivided dose: ≤ 0.5%

 

217

Trolamine, isolated or in combinations in topical products (with triclosan and/or tyrothricin)

Topical administration

 

218

Tyrothricin, in combinations (with benzalkonium, benzocaine, formaldehyde, trolamin, essential oil, etc.)

Oral administration: lozenges

Topical administration: mouthwash, oral ointment

 

219

Urea, isolated or in combination with vitamin E and/or bifonazol and/or herbal ingredients (aloe extract, etc.)

Topical administration

 

220

Vitamin A and provitamin A (Beta-carotene)

Oral administration: various forms with vitamin A ≤ 5000 IU/divided dose.

Topical administration

Eye drops

 

221

B vitamins, vitamin PP, isolated or in combinations.

Eye drops

 

222

Vitamins and provitamins, isolated (except for vitamin A and vitamin d) or in combination with vitamins, minerals, amino acids, taurine, fatty acid.

Oral administration: vitamin A in combinations ≤ 5000 IU/divided dose.

Topical administration

Providing supplemental vitamins, minerals, and nutrients.

223

Methylene blue

Topical administration

 

224

Xylometazoline, isolated or in combination with Benzalkonium

Nose drops with Xylometazoline ≤ 1%

 

2. For medicinal herbs:

2.1. The medicinal herb without toxicities and/or without severe harmful effects that are known or warned may be advertised on radio and television.

2.2. The medicinal herbs with toxicities shall be considered in each particular drug.

The oriental medicines and drugs from medicinal herbs with toxicities, which are issued with registration numbers by the Ministry of Health, and of which the effects and indications have been approved and are conformable with the Circular on advertising drugs issued by the Ministry of Health, may be advertised on radio and television.

 


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