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Document 52008XC0229(03)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
OJ C 56, 29.2.2008, p. 14–29
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
29.2.2008 |
EN |
Official Journal of the European Union |
C 56/14 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2008 to 31 January 2008
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
(2008/C 56/08)
— Issuing, maintenance or modification of a national marketing authorisation
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|
11.1.2008 |
Methotaxol-T |
See Annex I |
See Annex I |
15.1.2008 |
|
17.1.2008 |
Ivermectin |
See Annex II |
See Annex II |
18.1.2008 |
|
18.1.2008 |
Ciprofloxacin Nycomed |
See Annex III |
See Annex III |
21.1.2008 |
— Suspension of a national marketing authorization
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|
25.1.2008 |
Lumiracoxib |
See Annex IV |
See Annex IV |
29.1.2008 |
— Revocation of a national marketing authorization
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|
10.1.2008 |
Cetirizine dihydrochloride Dermapharm 10 mg |
See Annex V |
See Annex V |
11.1.2008 |
|
10.1.2008 |
Cetirizine dihydrochloride Copypharm 10 mg |
See Annex VI |
See Annex VI |
11.1.2008 |
|
10.1.2008 |
Cetirizine dihydrochloride Apex 10 mg |
See Annex VII |
See Annex VII |
11.1.2008 |
|
10.1.2008 |
Cetirizine dihydrochloride Nordic Drugs 10 mg |
See Annex VIII |
See Annex VIII |
11.1.2008 |
|
10.1.2008 |
Clobutinol |
See Annex IX |
See Annex IX |
11.1.2008 |
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.
ANNEX I
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/APPLICANT
|
Member State |
Applicant or marketing authorisation holder |
Product invented name |
Pharmaceutical form |
Strength |
Indication |
Recommended dose Frequency and route of administration |
|||||||||||||||||
|
The Netherlands |
|
Methoxasol-T |
Solution for oral administration |
Trimethoprim 20 mg/ml Sulfamethoxazole 100 mg/ml N-Methyl-2-pyrrolidone |
Pigs:
Non-egg-laying chickens:
|
Oral, via the drinking water Pigs: 2,5-5 mg trimethoprim and 12,5-25 mg sulfamethoxasole per kg body weight per day for 3-5 days Chickens: 5-12 mg trimethoprim and 25-58 mg sulfamethoxasole per kg body weight per day for 3-5 days |
|||||||||||||||||
|
Germany |
|
Methoxasol-T |
As for The Netherlands |
As for The Netherlands |
Therapeutic treatment of infections caused by trimethoprim and sulfamethoxasole susceptible bacteria Pigs:
Broilers:
|
Oral, via the drinking water Methoxasol-T should be administered daily in drinking water over a period of 3-4 days Pigs: 20,8 mg sulfamethoxasole + 4,2 mg trimethoprim per kg body weight per day for 3-4 days Broilers: 27,5 mg sulfamethoxasole + 5,5 mg trimethoprim per kg body weight per day for 3-4 days |
|||||||||||||||||
|
Austria |
|
Methoxasol — Lösung für Schweine und Hühner |
As for The Netherlands |
As for The Netherlands |
For the treatment of respiratory tract infections, urogenital, gastrointestinal and skin infections caused by pathogens sensitive to trimethoprim and sulfamethoxasole in pigs and poultry (broilers) |
As for Germany |
|||||||||||||||||
|
Poland |
|
Methoxasol |
As for The Netherlands |
As for The Netherlands |
For treatment of infections caused by organisms sensitive to combination of trimethoprim and sulfamethoxasole Pigs:
Hens:
|
Oral, via the drinking water Pigs: 24 mg/kg b.w., equivalent to 1 litre of the drug in 500 l drinking water, for 3-4 days Hens: 33 mg/kg b.w., equivalent to 1 litre of the drug in 750 l drinking water, for 3-4 days |
|||||||||||||||||
|
Hungary and Lithuania |
|
Methoxasol |
As for The Netherlands |
As for The Netherlands |
For the treatment of pigs and non-egg-laying chickens suffering from infectious diseases of the respiratory system caused by bacteria sensitive to sulfamethoxasole and trimethoprim (e.g. porcine A. pleuropneumoniae and gallinaceous E. coli) and for prophylactic use |
Oral, via the drinking water Pigs: 24 mg of active ingredient compound per kilogram of body weight or 200 ml of the medicine per 1 000 kg of body weight per day Poultry: 33 mg of active ingredient compound per kilogram of body weight or 275 ml of the medicine per 1 000 kg of body weight per day |
ANNEX II
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/APPLICANT(S)
|
Member State |
Marketing authorisation holder/applicant |
Product invented name |
Pharmaceutical form |
Strength |
Animal species |
Frequency and route of administration |
Recommended dose |
||||||
|
Ireland |
|
Ecomectin 18,7 mg/g Oral paste for horses |
Oral paste A white homogenous paste |
Ivermectin 18,7 mg/g |
Horses |
The paste is given by oral route |
One syringe division of paste per 100 kg body weight (based on a recommended dosage of 200 microgram ivermectin per kg body weight) |
||||||
|
Belgium |
As above |
Ivermax 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Cyprus |
As above |
Tizoval 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Czech Republic |
As above |
Vetimec 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Denmark |
As above |
Ecomectin 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Finland |
As above |
Ecomectin 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
France |
As above |
Divamectin 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Germany |
As above |
Tizoval 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Greece |
As above |
Tizoval 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Hungary |
As above |
Ecomectin 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Italy |
As above |
Tizoval 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
The Netherlands |
As above |
Ivermax 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Norway |
As above |
Tizoval 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Portugal |
As above |
Ecomectin 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Spain |
As above |
Ecomectin 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
Sweden |
As above |
Ecomectin 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
||||||
|
United Kingdom |
As above |
Animec 18,7 mg/g Oral paste for horses |
As above |
As above |
As above |
As above |
As above |
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State |
Marketing authorisation holder |
Applicant |
Invented name Name |
Strength |
Pharmaceutical form |
Route of administration |
Content (Concentration) |
|||
|
United Kingdom |
|
|
Ciprofloxacin |
2 mg/ml |
Solution for infusion |
Intravenous use |
50 ml, 100 ml, 200 ml |
|||
|
Denmark |
|
|
Ciprofloxacin Nycomed |
2 mg/ml |
Solution for infusion |
Intravenous use |
50 ml, 100 ml, 200 ml |
|||
|
Finland |
|
|
Ciprofloxacin Nycomed |
2 mg/ml |
Solution for infusion |
Intravenous use |
50 ml, 100 ml, 200 ml |
|||
|
Norway |
|
|
Ciprofloxacin Nycomed |
2 mg/ml |
Solution for infusion |
Intravenous use |
50 ml, 100 ml, 200 ml |
|||
|
Sweden |
|
|
Ciprofloxacin Nycomed |
2 mg/ml |
Solution for infusion |
Intravenous use |
50 ml, 100 ml, 200 ml |
ANNEX IV
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Austria |
|
Frexocel |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Prexigem |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Stellige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Czech Republic |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Cyprus |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Denmark |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Estonia |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Finland |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Frexocel |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Hirzia |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Stellige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Greece |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Greece |
|
Frexocel |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Hungary |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Iceland |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Latvia |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Lithuania |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Malta |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Netherlands |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Norway |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Poland |
|
Stellige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Poland |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Frexocel |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Hirzia |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Stellige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Slovakia |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Slovenia |
|
Frexocel |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Slovenia |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Spain |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Spain |
|
Stellige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
Sweden |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
United Kingdom |
|
Lumiracoxib 100 mg tablets |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
United Kingdom |
|
Prexige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
United Kingdom |
|
Frexocel |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
United Kingdom |
|
Stellige |
100 mg |
Film-coated tablet |
Oral use |
||||||
|
United Kingdom |
|
Hirzia |
100 mg |
Film-coated tablet |
Oral use |
ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Cetirizine dihydrochloride Dermapharm 10 mg and associated names
|
Member State |
Marketing authorisation holder |
Product name |
Strength |
Pharmaceutical form |
Route of administration |
|||
|
Austria |
|
Cetiderm 10 mg Filmtabletten |
10 mg |
Film-coated tablet |
Oral |
|||
|
Belgium |
|
Cetirizine dihydrochloride Dermapharm 10 mg filmomhulde tabletten |
10 mg |
Film-coated tablet |
Oral |
|||
|
Germany |
|
Cetiderm 10 mg Filmtabletten |
10 mg |
Film-coated tablet |
Oral |
|||
|
Netherlands |
|
Cetirizine dihydrochloride Dermapharm 10 mg tabletten |
10 mg |
Film-coated tablet |
Oral |
ANNEX VI
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Cetirizine dihydrochloride Copyfarm 10 mg and associated names
|
Member State |
Marketing authorisation holder |
Product name |
Strength |
Pharmaceutical form |
Route of administration |
||||
|
Denmark |
|
Cetirizin ‘Copyfarm’ |
10 mg |
Film-coated tablet |
Oral |
||||
|
Netherlands |
|
Cetirizine dihydrochloride Copyfarm 10 mg |
10 mg |
Film-coated tablet |
Oral |
||||
|
Norway |
|
Cetirizin Copyfarm |
10 mg |
Film-coated tablet |
Oral |
||||
|
Sweden |
|
Cetirizin Copyfarm |
10 mg |
Film-coated tablet |
Oral |
ANNEX VII
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Cetirizine dihydrochloride APEX 10 mg and associated names
|
Member State |
Marketing authorisation holder |
Product name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Belgium |
|
Doccetiri |
10 mg |
Film-coated tablet |
Oral |
||||||
|
Luxembourg |
|
Doccetiri —10 |
10 mg |
Film-coated tablet |
Oral |
||||||
|
Netherlands |
|
Cetirizine dihydrochloride — APEX 10 mg |
10 mg |
Film-coated tablet |
Oral |
ANNEX VIII
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Cetirizine dihydrochloride Nordic Drugs 10 mg and associated names
|
Member State |
Marketing authorisation holder |
Product name |
Strength |
Pharmaceutical form |
Route of administration |
|||
|
Denmark |
|
Gardex |
10 mg |
Film-coated tablet |
Oral |
|||
|
Finland |
|
Gardex |
10 mg |
Film-coated tablet |
Oral |
|||
|
Netherlands |
|
Cetirizine dihydrochloride Nordic Drugs 10 mg |
10 mg |
Film-coated tablet |
Oral |
|||
|
Norway |
|
Acura |
10 mg |
Film-coated tablet |
Oral |
|||
|
Sweden |
|
Acura |
10 mg |
Film-coated tablet |
Oral |
ANNEX IX
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Clobutinol containing medicinal products with marketing authorisation in the European Union
|
Member State |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||
|
Austria |
|
Silomat — Dragees |
40 mg |
Coated tablet |
Oral use |
||||
|
Austria |
|
Silomat — Hustensaft |
40 mg/10 ml |
Oral solution |
Oral use |
||||
|
Austria |
|
Silomat — Tropfen |
60 mg/ml |
Oral drops, solution |
Oral use |
||||
|
Belgium |
|
Silomat |
40 mg |
Tablets |
Oral use |
||||
|
Belgium |
|
Silomat |
60 mg |
Oral solution |
Oral use |
||||
|
Belgium |
|
Silomat |
20 mg/5 ml |
Syrup |
Oral use |
||||
|
Czech Republic |
|
Silomat |
20 mg/2 ml |
Solution for injection |
Intramuscular or intravenous use |
||||
|
Czech Republic |
|
Silomat |
40 mg/10 ml |
Syrup |
Oral use |
||||
|
Czech Republic |
|
Silomat |
900 mg /15 ml |
Oral drops, solution |
Oral use |
||||
|
Germany |
|
Clobutinol Kapseln 80 mg |
80 mg |
Capsule, hard |
Oral use |
||||
|
Germany |
|
Clobutinol -Tropfen TH |
40 mg/0,67 ml |
Oral drops, solution |
Oral use |
||||
|
Germany |
|
Silomat Ampullen gegen Reizhusten |
20 mg/2 ml |
Solution for injection |
Intramuscular or intravenous use |
||||
|
Germany |
|
Silomat Dragees gegen Reizhusten |
40 mg |
Coated tablet |
Oral use |
||||
|
Germany |
|
Silomat Saft gegen Reizhusten |
40 mg/10 ml |
Solution |
Oral use |
||||
|
Germany |
|
Silomat Tropfen gegen Reizhusten |
40 mg/0,67 ml |
Oral drops, solution |
Oral use |
||||
|
Germany |
|
Clobutinol-Chephasaar Kapsel 40 mg |
40 mg |
Capsule, hard |
Oral use |
||||
|
Germany |
|
Clobutinol-Chephasaar Saft 4mg/ml |
4 mg/1 ml |
Oral solution |
Oral use |
||||
|
Germany |
|
Clobutinol-MIP Kapsel 40 mg |
40 mg |
Capsule, hard |
Oral use |
||||
|
Germany |
|
Clobutinol-MIP Tropfen 80 mg/ml |
80 mg/1 ml |
Oral solution |
Oral use |
||||
|
Germany |
|
Rofatuss forte |
80 mg |
Capsule, hard |
Oral use |
||||
|
Germany |
|
Rofatuss N |
40 mg |
Capsule, hard |
Oral use |
||||
|
Germany |
|
Rofatuss Saft |
400 mg/100 ml |
Oral solution |
Oral use |
||||
|
Germany |
|
Rofatuss Tropfen |
80 mg/1 ml |
Oral drops, solution |
Oral use |
||||
|
Germany |
|
Silomat Dragees gegen Reizhusten |
40 mg |
Coated tablet |
Oral use |
||||
|
Germany |
|
Silomat Saft |
40 mg/10 ml |
Oral solution |
Oral use |
||||
|
Germany |
|
Clobutinol Tropfen |
40 mg/0,67 ml |
Oral drops, solution |
Oral use |
||||
|
Germany |
|
Tussed Hustenstiller Dragees |
40 mg |
Coated tablet |
Oral use |
||||
|
Germany |
|
Tussed Hustenstiller Saft |
40 mg/10 ml |
Oral solution |
Oral use |
||||
|
Germany |
|
Tussed Hustenstiller Tropfen |
40 mg/0,67 ml |
Solution |
Oral use |
||||
|
Germany |
|
Nullatuss Clobutinol Hustentropfen |
6 g/100 g |
Oral drops, solution |
Oral use |
||||
|
Germany |
|
Silomat Tropfen gegen Reizhusten |
40 mg/0,67 ml |
Oral solution |
Oral use |
||||
|
Germany |
|
Silomat Dragees gegen Reizhusten |
40 mg |
Coated tablet |
Oral use |
||||
|
Germany |
|
Silomat Saft gegen Reizhusten |
40 mg/10 ml |
Oral solution |
Oral use |
||||
|
Germany |
|
Hustenstiller-ratiopharm Clobutinol |
20 mg/5 ml |
Oral solution |
Oral use |
||||
|
Germany |
|
Hustenstiller-ratiopharm Clobutinol Kapseln |
80 mg |
Capsule, hard |
Oral use |
||||
|
Germany |
|
Hustenstiller-ratiopharm Clobutinol Tropfen |
80 mg/1 ml |
Oral solution |
Oral use |
||||
|
Greece |
|
Silomat Compositum (Clobutinol HCl + Orciprenaline Sulfate) |
20+5 mg/5ml |
Syrup |
Oral use |
||||
|
Greece |
|
Silomat |
60 mg/ml |
Oral solution, drops |
Oral use |
||||
|
Greece |
|
Silomat |
20 mg/5ml |
Syrup |
Oral use |
||||
|
Finland |
|
Silomat |
4 mg/ml |
Oral solution |
Oral use |
||||
|
Finland |
|
Silomat |
40 mg |
Coated tablet |
Oral use |
||||
|
Finland |
|
Mixtus |
4 mg/ml |
Oral solution |
Oral use |
||||
|
France |
|
Silomat |
0,40 % |
Syrup |
Oral use |
||||
|
France |
|
Silomat |
20 mg/2 ml |
Solution for injection |
Intramuscular or intravenous use |
||||
|
France |
|
Silomat |
40 mg |
Coated tablet |
Oral use |
||||
|
France |
|
Silomat |
6 % |
Oral drops, solution |
Oral use |