EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 52008XC1128(02)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2008 to 31 October 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2008 to 31 October 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2008 to 31 October 2008 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
OJ C 305, 28.11.2008, p. 10–88
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
28.11.2008 |
EN |
Official Journal of the European Union |
C 305/10 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2008 to 31 October 2008
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1) or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2) )
(2008/C 305/05)
— Issuing, maintenance or modification 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 |
|
6.10.2008 |
Zyrtec |
See Annex I |
See Annex I |
7.10.2008 |
|
7.10.2008 |
Risperdal |
See Annex II |
See Annex II |
10.10.2008 |
|
7.10.2008 |
Risperdal Consta |
See Annex III |
See Annex III |
9.10.2008 |
|
7.10.2008 |
Ciprofloxacin Bayer |
See Annex IV |
See Annex IV |
9.10.2008 |
|
24.10.2008 |
Moxifloxacin |
See Annex V |
See Annex V |
27.10.2008 |
— 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 |
|
24.10.2008 |
Ribavirin iQur |
See Annex VI |
See Annex VI |
27.10.2008 |
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.
ANNEX I
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Invented Name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
||||||
|
Austria |
|
Zyrtec 10 mg — Filmtabletten |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Austria |
|
Zyrtec 10 mg/ml — Tropfen |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Austria |
|
Zyrtec 1 mg/ml — orale Lösung |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Belgium |
|
Reactine |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Belgium |
|
Cetirizine-ucb |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Belgium |
|
Cetirizine-ucb |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Belgium |
|
Virlix |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Belgium |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Belgium |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Belgium |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Bulgaria |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Bulgaria |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Cyprus |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Cyprus |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Czech Republic |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Czech Republic |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Denmark |
|
Benaday |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Denmark |
|
Benaday |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Denmark |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Denmark |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Denmark |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Estonia |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Estonia |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Estonia |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Finland |
|
Benaday |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Finland |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Finland |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Finland |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
France |
|
Reactine |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
France |
|
Virlix |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
France |
|
Virlix |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
France |
|
Virlix |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
France |
|
Cetirizine ucb 10 mg |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
France |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
France |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
France |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
France |
|
Actifed allergie cetirizine 10 mg |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
France |
|
Zyrtecset |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Germany |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Germany |
|
Zyrtec p |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Germany |
|
Zyrtec p tropfen |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Germany |
|
Zyrtec saft |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Germany |
|
Zyrtec tropfen |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Germany |
|
Reactine |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Greece |
|
Ziptek |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Greece |
|
Ziptek |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Hungary |
|
Zyrtec cseppek |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Hungary |
|
Zyrtec filmtabletta |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Hungary |
|
Zyrtec oldat |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Hungary |
|
Zyrtec start filmtabletta |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Ireland |
|
Zirtek oral solution 1 mg/ml |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Ireland |
|
Zirtek tablets |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Italy |
|
Formistin |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Italy |
|
Formistin |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Italy |
|
Virlix |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Italy |
|
Virlix |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Italy |
|
Zirtec 1 mg/ml soluzione orale |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Italy |
|
Zirtec 10 mg compresse rivestite con film |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Italy |
|
Zirtec 10 mg/ml gocce orali soluzione |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Latvia |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Latvia |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Latvia |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Lithuania |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Lithuania |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Lithuania |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Luxembourg |
|
Reactine |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Luxembourg |
|
Sinutab Decongestif & Antihistaminicum |
5 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Luxembourg |
|
Virlix |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Luxembourg |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Luxembourg |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Luxembourg |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Luxembourg |
|
Cetirizine-ucb |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Luxembourg |
|
Cetirizine-ucb |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Malta |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Malta |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Netherlands |
|
Reactine |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Netherlands |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Netherlands |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Norway |
|
Reactine |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Norway |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Norway |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Norway |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Poland |
|
Reactine |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Poland |
|
Virlix |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Poland |
|
Virlix |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Poland |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Poland |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Poland |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Poland |
|
Zyrtec ucb |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Portugal |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Portugal |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Portugal |
|
Zyrtec |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Portugal |
|
Virlix |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Portugal |
|
Virlix |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Romania |
|
Zyrtec |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Romania |
|
Zyrtec |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Slovakia |
|
Zyrtec gtt por 10 mg/ml |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Slovakia |
|
Zyrtec tbl flm 10 mg |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Slovenia |
|
Zyrtec 1 mg/ml peroralna raztopina |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Slovenia |
|
Zyrtec 10 mg filmsko obložene tablete |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Slovenia |
|
Zyrtec 10 mg/ml peroralne kapljice, raztopina |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Spain |
|
Alerlisin |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Spain |
|
Alerlisin |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Spain |
|
Alerlisin |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Spain |
|
Virdos |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Spain |
|
Virlix |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Spain |
|
Virlix |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Spain |
|
Reactine |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Spain |
|
Reactine 5 mg/5 ml solución oral |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Spain |
|
Zyrtec comprimidos recubiertos con pelicula |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Spain |
|
Zyrtec gotas orales en solución |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Spain |
|
Zyrtec solución oral |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
Spain |
|
Alerrid 10 mg comprimidos recubierto con pelicula |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Sweden |
|
Alerid |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Sweden |
|
Zyrlex |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Sweden |
|
Zyrlex |
10 mg/ml |
Oral drops, solution |
Oral use |
10 mg/ml |
||||||
|
Sweden |
|
Zyrlex |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
United Kingdom |
|
Benadryl allergy oral syrup |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
United Kingdom |
|
Benadryl for children allergy solution |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
United Kingdom |
|
Benadryl one a day |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
United Kingdom |
|
Benadryl one a day |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
United Kingdom |
|
Zirtek allergy relief for children |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
United Kingdom |
|
Zirtek allergy relief tablets |
10 mg |
Film-coated tablet |
Oral use |
|
||||||
|
United Kingdom |
|
Zirtek allergy solution |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
United Kingdom |
|
Benadryl allergy solution |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
||||||
|
United Kingdom |
|
Benadryl allergy oral solution |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
INN |
Invented Name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
|||||
|
Austria |
|
Risperidone |
Risperdal Quicklet 0,5 mg — Tabletten |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Risperdal Quicklet 1 mg — Tabletten |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Risperdal Quicklet 2 mg — Tabletten |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Risperdal Quicklet 3 mg — Tabletten |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Risperdal Quicklet 4 mg — Tabletten |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Risperdal 0,5 mg — Filmtabletten |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Risperdal 1 mg — Filmtabletten |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Risperdal 2 mg — Filmtabletten |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Risperdal 3 mg — Filmtabletten |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Risperdal 4 mg — Filmtabletten |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Risperdal 6 mg — Filmtabletten |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Risperdal 1 mg/ml — orale Lösung |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Austria |
|
Risperidone |
Rispolin Quicklet 0,5 mg — Tabletten |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Rispolin Quicklet 1 mg — Tabletten |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Rispolin Quicklet 2 mg — Tabletten |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Rispolin Quicklet 3 mg — Tabletten |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Rispolin Quicklet 4 mg — Tabletten |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Rispolin 0,5 mg — Filmtabletten |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Rispolin 1 mg — Filmtabletten |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Rispolin 2 mg — Filmtabletten |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Rispolin 3 mg — Filmtabletten |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Rispolin 4 mg — Filmtabletten |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Rispolin 6 mg — Filmtabletten |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Austria |
|
Risperidone |
Rispolin 1 mg/ml — orale Lösung |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Belgium |
|
Risperidone |
Risperidone J-C Instasolv |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Belgium |
|
Risperidone |
Risperdal |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperdal |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperdal Instasolv |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperdal Instasolv |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperdal Instasolv |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperidone J-C |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperidone J-C |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperidone J-C |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Belgium |
|
Risperidone |
Risperidone J-C |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperidone J-C |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperidone J-C |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperidone J-C |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperidone J-C Instasolv |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Belgium |
|
Risperidone |
Risperidone J-C Instasolv |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Bulgaria |
|
Risperidone |
Rispolept |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Bulgaria |
|
Risperidone |
Rispolept |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Bulgaria |
|
Risperidone |
Rispolept |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Bulgaria |
|
Risperidone |
Rispolept |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Bulgaria |
|
Risperidone |
Rispolept |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Cyprus |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Cyprus |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Cyprus |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Cyprus |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Cyprus |
|
Risperidone |
Risperdal |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ 1 ml |
|||||
|
Czech Republic |
|
Risperidone |
Risperdal 1 mg |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Czech Republic |
|
Risperidone |
Risperdal 2 mg |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Czech Republic |
|
Risperidone |
Risperdal 3 mg |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Czech Republic |
|
Risperidone |
Risperdal 4 mg |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Czech Republic |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ 1 ml |
|||||
|
Czech Republic |
|
Risperidone |
Risperdal Quicklet |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Czech Republic |
|
Risperidone |
|
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Czech Republic |
|
Risperidone |
Risperdal Quicklet |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Belivon |
1 mg |
Oral solution |
Oral use |
1 mg/ 1 ml |
|||||
|
Denmark |
|
Risperidone |
Belivon |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Belivon |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Belivon |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Belivon |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Risperdal |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ 1 ml |
|||||
|
Denmark |
|
Risperidone |
Risperdal |
0,5 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Risperdal |
1 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Denmark |
|
Risperidone |
Risperdal |
2 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Estonia |
|
Risperidone |
Rispolept |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Estonia |
|
Risperidone |
Rispolept |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Estonia |
|
Risperidone |
Rispolept |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Estonia |
|
Risperidone |
Rispolept |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Estonia |
|
Risperidone |
Rispolept |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Estonia |
|
Risperidone |
Rispolept Quicklet |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Estonia |
|
Risperidone |
Rispolept Quicklet |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Finland |
|
Risperidone |
Risperdal |
0,25 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal Instasolv |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal Instasolv |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal Instasolv |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal Instasolv |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Finland |
|
Risperidone |
Risperdal Instasolv |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Belivon |
1 mg |
Scored tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Belivon |
2 mg |
Scored tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Belivon |
3 mg |
Scored tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Belivon |
4 mg |
Scored tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Risperdal |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Risperdal |
1 mg |
Half-scored tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Risperdal |
2 mg |
Half-scored tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Risperdal |
3 mg |
Half-scored tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Risperdal |
4 mg |
Half-scored tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Risperdal |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
France |
|
Risperidone |
Risperdaloro |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Risperdaloro |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Risperdaloro |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Risperdaloro |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
France |
|
Risperidone |
Risperdaloro |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperdal 1 mg |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperdal 2 mg |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperdal 3 mg |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperdal 4 mg |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperdal Filmtabletten 0,25 mg |
0,25 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperdal Filmtabletten 0,5 mg |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperdal Filmtabletten 6 mg |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperdal Lösung 1 mg/ml |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Germany |
or
|
Risperidone |
Risperdal Quicklet 1 mg |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperdal Quicklet 2 mg |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperdal Quicklet 3 mg |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperdal Quicklet 4 mg |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperidon-Janssen Filmtabletten 6 mg |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Risperidon-Janssen Loesung 1 mg/ml |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Germany |
or
|
Risperidone |
Belivon 0,5 mg Filmtabletten |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Belivon 1 mg Filmtabletten |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Belivon 1 mg/ml Lösung |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Germany |
or
|
Risperidone |
Belivon 2 mg Filmtabletten |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Belivon 3 mg Filmtabletten |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Belivon 4 mg Filmtabletten |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Belivon 6 mg Filmtabletten |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Rehablit 1 mg |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Rehablit 2 mg |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Rehablit 3 mg |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Rehablit 4 mg |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Rehablit Filmtabletten 6 mg |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Germany |
or
|
Risperidone |
Rehablit Lösung 1 mg/ml |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Greece |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Greece |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Greece |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Greece |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Greece |
|
Risperidone |
Risperdal |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Greece |
|
Risperidone |
Risperdal |
8 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Greece |
|
Risperidone |
Risperdal |
1 mg/1 ml |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Greece |
|
Risperidone |
Risperdal Quicklet |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Greece |
|
Risperidone |
Risperdal Quicklet |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Greece |
|
Risperidone |
Risperdal Quicklet |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Greece |
|
Risperidone |
Risperdal Quicklet |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Greece |
|
Risperidone |
Risperdal Quicklet |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Hungary |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Hungary |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Hungary |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Hungary |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Hungary |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Hungary |
|
Risperidone |
Risperdal Quicklet |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Hungary |
|
Risperidone |
Risperdal Quicklet |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Hungary |
|
Risperidone |
Risperdal Quicklet |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Iceland |
|
Risperidone |
Risperdal |
0,5 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Iceland |
|
Risperidone |
Risperdal |
1 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Iceland |
|
Risperidone |
Risperdal |
2 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Iceland |
|
Risperidone |
Risperdal |
3 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Iceland |
|
Risperidone |
Risperdal |
4 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Iceland |
|
Risperidone |
Risperdal |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Iceland |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Iceland |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Iceland |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Iceland |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Iceland |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal liquid |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Ireland |
|
Risperidone |
Risperdal |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal |
0,25 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal quicklet |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal quicklet |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal quicklet |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal quicklet |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Ireland |
|
Risperidone |
Risperdal quicklet |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Italy |
|
Risperidone |
Risperdal |
0,5 mg |
Tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Risperdal |
0,25 mg |
Tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Risperdal |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Risperdal |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Risperdal |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Risperdal |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Belivon |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Italy |
|
Risperidone |
Belivon |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Belivon |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Belivon |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Belivon |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Actase |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Italy |
|
Risperidone |
Actase |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Actase |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Actase |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Italy |
|
Risperidone |
Actase |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Latvia |
|
Risperidone |
Rispolept |
1 mg |
Tablets |
Oral use |
|
|||||
|
Latvia |
|
Risperidone |
Rispolept |
2 mg |
Tablets |
Oral use |
|
|||||
|
Latvia |
|
Risperidone |
Rispolept |
3 mg |
Tablets |
Oral use |
|
|||||
|
Latvia |
|
Risperidone |
Rispolept |
4 mg |
Tablets |
Oral use |
|
|||||
|
Latvia |
|
Risperidone |
Rispolept |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Latvia |
|
Risperidone |
Risperdal Quicklet |
1 mg |
Orodispersible tablets |
Oral use |
|
|||||
|
Latvia |
|
Risperidone |
Risperdal Quicklet |
2 mg |
Orodispersible tablets |
Oral use |
|
|||||
|
Latvia |
|
Risperidone |
Risperdal Quicklet |
4 mg |
Orodispersible tablets |
Oral use |
|
|||||
|
Lithuania |
|
Risperidone |
Rispolept |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Lithuania |
|
Risperidone |
Rispolept |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Lithuania |
|
Risperidone |
Rispolept |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Lithuania |
|
Risperidone |
Rispolept |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Lithuania |
|
Risperidone |
Rispolept |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Lithuania |
|
Risperidone |
Rispolept Quicklet |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Lithuania |
|
Risperidone |
Rispolept Quicklet |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperidone J-C Instasolv |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Luxembourg |
|
Risperidone |
Risperdal |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperdal |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperdal Instasolv |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperdal Instasolv |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperdal Instasolv |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperidone J-C |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperidone J-C |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperidone J-C |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Luxembourg |
|
Risperidone |
Risperidone J-C |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperidone J-C |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperidone J-C |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperidone J-C |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperidone J-C Instasolv |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Luxembourg |
|
Risperidone |
Risperidone J-C Instasolv |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Malta |
|
Risperidone |
Risperdal |
1 mg |
Tablets |
Oral use |
|
|||||
|
Malta |
|
Risperidone |
Risperdal |
2 mg |
Tablets |
Oral use |
|
|||||
|
Malta |
|
Risperidone |
Risperdal |
3 mg |
Tablets |
Oral use |
|
|||||
|
Malta |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Malta |
|
Risperidone |
Risperdal Quicklets |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Malta |
|
Risperidone |
Risperdal Quicklets |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Malta |
|
Risperidone |
Risperdal Quicklets |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Risperdal Risperdal omhulde tabletten 0,5 mg |
0,5 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Risperdal Risperdal omhulde tabletten 1 mg |
1 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Risperdal Risperdal omhulde tabletten 2 mg |
2 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Risperdal Risperdal omhulde tabletten 3 mg |
3 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Risperdal Risperdal omhulde tabletten 4 mg |
4 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Risperdal Risperdal omhulde tabletten 6 mg |
6 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Risperdal Risperdal omhulde tabletten 8 mg |
8 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Belivon Belivon omhulde tabletten 1 mg |
1 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Belivon Belivon omhulde tabletten 2 mg |
2 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Belivon Belivon omhulde tabletten 3 mg |
3 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Belivon |
4 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Netherlands |
|
Risperidone |
Risperdal Risperdal 1 mg/ml, drank |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Netherlands |
|
Risperidone |
Belivon Belivon 1 mg/ml |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Norway |
|
Risperidone |
Belivon |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Norway |
|
Risperidone |
Belivon |
1 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Belivon |
2 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Belivon |
3 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Belivon |
4 mg |
Film-coated tablets |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Risperdal |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Risperdal |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Risperdal |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Risperdal |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Risperdal |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Risperdal |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Norway |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Poland |
|
Risperidone |
Rispolept |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Poland |
|
Risperidone |
Rispolept |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Poland |
|
Risperidone |
Rispolept |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Poland |
|
Risperidone |
Rispolept |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Poland |
|
Risperidone |
Rispolept |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Poland |
|
Risperidone |
Rispolept Quicklet |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Poland |
|
Risperidone |
Rispolept Quicklet |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Poland |
|
Risperidone |
Rispolept Quicklet |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Portugal |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Portugal |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Portugal |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Portugal |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Portugal |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Portugal |
|
Risperidone |
Risperdal |
0,25 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Portugal |
|
Risperidone |
Risperdal |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Portugal |
|
Risperidone |
Risperdal Quicklet |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Portugal |
|
Risperidone |
Risperdal Quicklet |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Portugal |
|
Risperidone |
Risperdal Quicklet |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Portugal |
|
Risperidone |
Risperdal Quicklet |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Portugal |
|
Risperidone |
Risperdal Quicklet |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Romania |
|
Risperidone |
Rispolept 1 mg |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Romania |
|
Risperidone |
Rispolept 2 mg |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Romania |
|
Risperidone |
Rispolept 3 mg |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Romania |
|
Risperidone |
Rispolept 4 mg |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Romania |
|
Risperidone |
Rispolept |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Romania |
|
Risperidone |
Rispolept Quicklet |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Romania |
|
Risperidone |
Rispolept Quicklet |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Slovak Republic |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Slovak Republic |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Slovak Republic |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Slovak Republic |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Slovak Republic |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Slovak Republic |
|
Risperidone |
Risperdal Quicklet |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Slovak Republic |
|
Risperidone |
Risperdal Quicklet |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Slovak Republic |
|
Risperidone |
Risperdal Quicklet |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Slovak Republic |
|
Risperidone |
Risperdal Quicklet |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Slovenia |
|
Risperidone |
Risperdal 1 mg filmsko obložene tablete |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Slovenia |
|
Risperidone |
Risperdal 2 mg filmsko obložene tablete |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Slovenia |
|
Risperidone |
Risperdal 3 mg filmsko obložene tablete |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Slovenia |
|
Risperidone |
Risperdal 4 mg filmsko obložene tablete |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Slovenia |
|
Risperidone |
Risperdal 1 mg/ml peroralna raztopina |
1 mg/ml |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Slovenia |
|
Risperidone |
Risperdal Quicklet 0,5 mg orodisperzibilna tableta |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Slovenia |
|
Risperidone |
Risperdal Quicklet 1 mg orodisperzibilna tableta |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Slovenia |
|
Risperidone |
Risperdal Quicklet 2 mg orodisperzibilna tableta |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Spain |
|
Risperidone |
Risperdal flas |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Spain |
|
Risperidone |
Risperdal flas |
4 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Spain |
|
Risperidone |
Risperdal flas |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Spain |
|
Risperidone |
Risperdal flas |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Spain |
|
Risperidone |
Risperdal flas |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
Spain |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Spain |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Spain |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Spain |
|
Risperidone |
Risperdal |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Spain |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Sweden |
|
Risperidone |
Belivon |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Belivon |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Belivon |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Belivon |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Belivon |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Belivon |
1 mg |
Oral solution |
Oral use |
1 mg/1ml |
|||||
|
Sweden |
|
Risperidone |
Risperdal |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Risperdal |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
Sweden |
|
Risperidone |
Risperdal |
0,5 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Risperdal |
1 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Risperdal |
2 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Risperdal |
3 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
Sweden |
|
Risperidone |
Risperdal |
4 mg |
Oral lyophilisate |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal |
0,25 mg |
Film-coated tablet |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal |
0,5 mg |
Film-coated tablet |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal |
1 mg |
Film-coated tablet |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal |
2 mg |
Film-coated tablet |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal |
3 mg |
Film-coated tablet |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal |
4 mg |
Film-coated tablet |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal |
6 mg |
Film-coated tablet |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal liquid |
1 mg |
Oral solution |
Oral use |
1 mg/ml |
|||||
|
United Kingdom |
|
Risperidone |
Risperdal quicklet |
0,5 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal quicklet |
1 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal quicklet |
2 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal quicklet |
3 mg |
Orodispersible tablet |
Oral use |
|
|||||
|
United Kingdom |
|
Risperidone |
Risperdal quicklet |
4 mg |
Orodispersible tablet |
Oral use |
|
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Invented Name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
|||||
|
Austria |
|
Risperdal Consta |
12,5 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
12,5 mg/2 ml |
|||||
|
Austria |
|
Risperdal Consta |
25 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Austria |
|
Risperdal Consta |
37,5 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Austria |
|
Risperdal Consta |
50 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Austria |
|
Rispolin Consta |
12,5 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
12,5 mg/2ml |
|||||
|
Austria |
|
Rispolin Consta |
25 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
25 mg/2ml |
|||||
|
Austria |
|
Rispolin Consta |
37,5 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Austria |
|
Rispolin Consta |
50 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Belgium |
|
Belivon Consta |
25 mg |
Powder and solvent for solution for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Belgium |
|
Belivon Consta |
37,5 mg |
Powder and solvent for solution for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Belgium |
|
Belivon Consta |
50 mg |
Powder and solvent for solution for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Belgium |
|
Risperdal Consta |
25 mg |
Powder and solvent for solution for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Belgium |
|
Risperdal Consta |
37,5 mg |
Powder and solvent for solution for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Belgium |
|
Risperdal Consta |
50 mg |
Powder and solvent for solution for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Bulgaria |
|
Rispolept Consta |
25 mg |
Powder and solvent for solution for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Bulgaria |
|
Rispolept Consta |
37,5 mg |
Powder and solvent for solution for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Bulgaria |
|
Rispolept Consta |
50 mg |
Powder and solvent for solution for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Cyprus |
|
Risperdal Consta |
25 mg |
Powder for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Cyprus |
|
Risperdal Consta |
37,5 mg |
Powder for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Cyprus |
|
Risperdal Consta |
50 mg |
Powder for suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Czech Republic |
|
Risperdal Consta 25 mg |
25 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Czech Republic |
|
Risperdal Consta 37,5 mg |
37,5 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
37,5 mg/2ml |
|||||
|
Czech Republic |
|
Risperdal Consta 50 mg |
50 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
50 mg/2ml |
|||||
|
Estonia |
|
Rispolept Consta |
25 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
25mg/2ml |
|||||
|
Estonia |
|
Rispolept Consta |
37,5 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
37,5mg/2ml |
|||||
|
Estonia |
|
Rispolept Consta |
50 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
50mg/2ml |
|||||
|
Finland |
|
Risperdal Consta |
12,5 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
12,5 mg/2ml |
|||||
|
Finland |
|
Risperdal Consta |
25 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
25mg/2ml |
|||||
|
Finland |
|
Risperdal Consta |
37,5 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Finland |
|
Risperdal Consta |
50 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
France |
|
Risperdalconsta LP |
25 mg |
Powder for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
France |
|
Risperdalconsta LP |
37,5 mg |
Powder for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
France |
|
Risperdalconsta LP |
50 mg |
Powder for suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Germany |
|
Risperdal Consta |
25 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Germany |
|
Risperdal Consta |
37,5 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Germany |
|
Risperdal Consta |
50 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Germany |
|
Risperidon-Janssen Consta |
25 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Germany |
|
Risperidon-Janssen Consta |
37,5 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Germany |
|
Risperidon-Janssen Consta |
50 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Germany |
|
Rispon-Janssen Consta |
25 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Germany |
|
Rispon-Janssen Consta |
37,5 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Germany |
|
Rispon-Janssen Consta |
50 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Greece |
|
Risperdal Consta |
25 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Greece |
|
Risperdal Consta |
37,5 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Greece |
|
Risperdal Consta |
50 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
50 mg/2ml |
|||||
|
Iceland |
|
Risperdal Consta |
50 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Iceland |
|
Risperdal Consta |
37,5 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Iceland |
|
Risperdal Consta |
25 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Ireland |
|
Risperdal Consta |
25 mg |
Powder for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Ireland |
|
Risperdal Consta |
37,5 mg |
Powder for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Ireland |
|
Risperdal Consta |
50 mg |
Powder for suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Italy |
|
Risperdal |
25 mg |
Powder for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Italy |
|
Risperdal |
37,5 mg |
Powder for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Italy |
|
Risperdal |
50 mg |
Powder for suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Latvia |
|
Rispolept Consta |
25 mg |
Prolonged release powder and solvent for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Latvia |
|
Rispolept Consta |
50 mg |
Prolonged release powder and solvent for suspension for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Latvia |
|
Rispolept Consta |
37,5 mg |
Prolonged release powder and solvent for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Lithuania |
|
Rispolept Consta |
25 mg |
Prolonged-release powder and solvent for solution for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Lithuania |
|
Rispolept Consta |
37,5 mg |
Prolonged-release powder and solvent for solution for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Lithuania |
|
Rispolept Consta |
50 mg |
Prolonged-release powder and solvent for solution for injection |
Intramuscular use |
50 mg/2ml |
|||||
|
Malta |
|
Risperdal Consta |
25 mg |
Powder for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Malta |
|
Risperdal Consta |
37,5 mg |
Powder for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Malta |
|
Risperdal Consta |
50 mg |
Powder for suspension for injection |
Intramuscular use |
50 mg/2ml |
|||||
|
Netherlands |
|
Risperdal Consta |
12,5 mg |
Powder and solution for suspension and injection |
Intramuscular use |
12,5 mg/2 ml |
|||||
|
Netherlands |
|
Risperdal Consta |
25 mg |
Powder and solution for suspension and injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Netherlands |
|
Risperdal Consta |
37,5 mg |
Powder and solution for suspension and injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Netherlands |
|
Risperdal Consta |
50 mg |
Powder and solution for suspension and injection |
Intramuscular use |
50 mg/2ml |
|||||
|
Norway |
|
Risperdal Consta |
25 mg |
Prolonged-release powder (microspheres) and a solvent for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Norway |
|
Risperdal Consta |
37,5 mg |
Prolonged-release powder (microspheres) and a solvent for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Norway |
|
Risperdal Consta |
50 mg |
Prolonged-release powder (microspheres) and a solvent for suspension for injection |
Intramuscular use |
50 mg/2ml |
|||||
|
Poland |
|
Rispolept Consta |
25 mg |
Prolonged-release microcapsule and solvent for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Poland |
|
Rispolept Consta |
37,5 mg |
Prolonged-release microcapsule and solvent for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Poland |
|
Rispolept Consta |
50 mg |
Prolonged-release microcapsule and solvent for suspension for injection |
Intramuscular use |
50 mg/2ml |
|||||
|
Portugal |
|
Risperdal Consta |
25 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Portugal |
|
Risperdal Consta |
37,5 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Portugal |
|
Risperdal Consta |
50 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
50 mg/2ml |
|||||
|
Romania |
|
Rispolept Consta |
25 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Romania |
|
Rispolept Consta |
37,5 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
37,5 mg/2ml |
|||||
|
Romania |
|
Rispolept Consta |
50 mg |
Powder and solvent for suspension for injection |
Intramuscular use |
50 mg/2ml |
|||||
|
Slovak Republic |
|
Risperdal Consta |
25 mg |
Powder and solvent for suspension for injection |
Intramuscural use |
25 mg/2 ml |
|||||
|
Slovak Republic |
|
Risperdal Consta |
37,5 mg |
Powder and solvent for suspension for injection |
Intramuscural use |
37,5 mg/2 ml |
|||||
|
Slovak Republic |
|
Risperdal Consta |
50 mg |
Powder and solvent for suspension for injection |
Intramuscural use |
50 mg/2ml |
|||||
|
Slovenia |
|
Risperdal Consta |
25 mg |
Prolonged release powder and solvent for suspension for injection |
Intramuscural use |
25 mg/2 ml |
|||||
|
Slovenia |
|
Risperdal Consta |
37,5 mg |
Prolonged release powder and solvent for suspension for injection |
Intramuscural use |
37,5 mg/2ml |
|||||
|
Slovenia |
|
Risperdal Consta |
50 mg |
Prolonged release powder and solvent for suspension for injection |
Intramuscural use |
50 mg/2ml |
|||||
|
Spain |
|
Risperdal Consta |
25 mg |
Powder and solvent for solution for injection |
Intramuscular use |
25 mg/2ml |
|||||
|
Spain |
|
Risperdal Consta |
37.5 mg |
Powder and solvent for solution for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
Spain |
|
Risperdal Consta |
50 mg |
Powder and solvent for solution for injection |
Intramuscular use |
50 mg/2 ml |
|||||
|
Sweden |
|
Risperdal Consta |
25 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
Sweden |
|
Risperdal Consta |
37,5 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
37,5 mg/2ml |
|||||
|
Sweden |
|
Risperdal Consta |
50 mg |
Powder and solvent for prolonged-release suspension for injection |
Intramuscular use |
50 mg/2ml |
|||||
|
United Kingdom |
|
Risperdal Consta |
25 mg |
Powder for suspension for injection |
Intramuscular use |
25 mg/2 ml |
|||||
|
United Kingdom |
|
Risperdal Consta |
37,5 mg |
Powder for suspension for injection |
Intramuscular use |
37,5 mg/2 ml |
|||||
|
United Kingdom |
|
Risperdal Consta |
50 mg |
Powder for suspension for injection |
Intramuscular use |
50 mg/2 ml |
ANNEX IV
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Invented Name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
|||||||
|
Austria |
|
Ciproxin |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciproxin |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxin |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
Ciproxin |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprofloxacine ‘BAYER’ |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprofloxacine ‘BAYER’ |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
5 % |
Oral suspension |
Oral use |
5 % |
|||||||||
|
Ciproxin |
10 % |
Oral suspension |
Oral use |
10 % |
|||||||||
|
Belgium |
|
Ciproxine |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||
|
Ciproxine |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxine |
100 mg |
Film-coated tablets |
Oral use |
100 mg |
|||||||||
|
Ciproxine |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||||
|
Ciproxine |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxine |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
Ciproxine |
5 g/100 ml |
Oral suspension |
Oral use |
50 mg/ ml |
|||||||||
|
Ciproxine |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxine |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Bulgaria |
|
Ciprobay |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciprobay |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciprobay |
200 mg /100ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay XR |
500 mg |
Modified release tablets |
Oral use |
500 mg |
|||||||||
|
Cyprus |
|
Ciproxin |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciproxin |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxin |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Czech Republic |
|
Ciprobay |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||
|
Ciprobay |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay Uro |
100 mg |
Film-coated tablets |
Oral use |
100 mg |
|||||||||
|
Ciprobay |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||||
|
Ciprobay |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciprobay |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
Denmark |
|
Ciproxin |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciproxin |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxin |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
Ciproxin |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
50 mg/ml |
Oral suspension |
Oral use |
50 mg/ml |
|||||||||
|
Ciproxin |
100 mg/ml |
Oral suspension |
Oral use |
100 mg/ml |
|||||||||
|
Estonia |
|
Ciproxin |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciproxin |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxin |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Finland |
|
Ciproxin |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciproxin |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxin |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
Ciproxin |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
France |
|
Ciflox |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciflox |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Uniflox |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciflox |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
Ciflox |
250 mg/5 ml |
Oral suspension |
Oral use |
50 mg/ml |
|||||||||
|
Ciflox |
500 mg/5 ml |
Oral suspension |
Oral use |
100 mg/ml |
|||||||||
|
Ciflox |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciflox |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Germany |
|
CIPROBAY |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||
|
CIPROBAY |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
CIPROBAY |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
CIPROBAY URO |
100 mg |
Film-coated tablets |
Oral use |
100 mg |
|||||||||
|
CIPROBAY |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||||
|
CIPROBAY |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
CIPROBAY |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
CIPROBAY |
5 g/100 ml |
Oral suspension |
Oral use |
50 mg/ml |
|||||||||
|
CIPROBAY |
10 g/100 ml |
Oral suspension |
Oral use |
100 mg/ml |
|||||||||
|
Ciprofloxacin ANTIBAC |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
||||||||
|
Ciprofloxacin ANTIBAC |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciprofloxacin ANTIBAC |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
Ciprofloxacin ANTIBAC |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprofloxacin ANTIBAC |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprofloxacin ANTIBAC |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprofloxacin BAYER |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprofloxacin BAYER |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprofloxacin BAYER |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprofloxacin VITAL |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprofloxacin VITAL |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprofloxacin VITAL |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Greece |
|
CIPROXIN |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||
|
CIPROXIN |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
CIPROXIN |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
CIPROXIN |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
CIPROXIN |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
CIPROXIN |
250 mg/5 ml |
Oral suspension |
Oral use |
50 mg/ml |
|||||||||
|
CIPROXIN |
500 mg/5 ml |
Oral suspension |
Oral use |
100 mg/ml |
|||||||||
|
CIPROXIN XR |
500 mg |
Modified release tablets |
Oral use |
500 mg |
|||||||||
|
CIPROXIN XR |
1 000 mg |
Modified release tablets |
Oral use |
1 000 mg |
|||||||||
|
Hungary |
|
Ciprobay |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciprobay |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciprobay |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Iceland |
|
Ciproxin |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciproxin |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxin |
750 mg |
Film-coated tablets |
Oral use |
750mg |
|||||||||
|
Ciproxin |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ireland |
|
Ciproxin |
100 mg |
Film-coated tablets |
Oral use use |
100 mg |
|||||||
|
Ciproxin |
250 mg |
Film-coated tablets |
Oral use use |
250 mg |
|||||||||
|
Ciproxin |
500 mg |
Film-coated tablets |
Oral use use |
500 mg |
|||||||||
|
Ciproxin |
750 mg |
Film-coated tablets |
Oral use use |
750 mg |
|||||||||
|
Ciproxin |
250 mg/5 ml |
Oral suspension |
Oral use use |
50 mg/ml |
|||||||||
|
Ciproxin |
500 mg/5 ml |
Oral suspension |
Oral use use |
100 mg/ml |
|||||||||
|
Ciproxin |
100 mg/50ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
200 mg/100ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
400 mg/200ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Italy |
|
CIFLOX |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
CIFLOX |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
CIPROXIN |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
||||||||
|
CIPROXIN |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
CIPROXIN |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
CIPROXIN |
500 mg |
Modified release tablets |
Oral use |
500 mg |
|||||||||
|
CIPROXIN |
1 000 mg |
Modified release tablets |
Oral use |
1 000 mg |
|||||||||
|
CIPROXIN |
250 mg |
Oral suspension |
Oral use |
50 mg/ml |
|||||||||
|
CIPROXIN |
500 mg |
Oral suspension |
Oral use |
100 mg/ml |
|||||||||
|
CIPROXIN |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
CIPROXIN |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
CIPROXIN |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Latvia |
Not authorised |
|
|
|
|
|
|||||||
|
Lithuania |
Not authorised |
|
|
|
|
|
|||||||
|
Luxembourg |
|
Ciproxine |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||
|
Ciproxine |
100 mg |
Film-coated tablets |
Oral use |
100 mg |
|||||||||
|
Ciproxine |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||||
|
Ciproxine |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxine |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
Ciproxine |
5 g/100 ml |
Oral suspension |
Oral use |
250 mg/5 ml |
|||||||||
|
Ciproxine |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxine |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Malta |
|
Ciproxin |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciproxin |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxin |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Netherlands |
|
Ciproxin |
100 mg |
Film-coated tablets |
Oral use |
100 mg |
|||||||
|
Ciproxin |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||||
|
Ciproxin |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxin |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
Ciproxin |
5 g/100 ml |
Oral suspension |
Oral use |
50 mg/ml |
|||||||||
|
Ciproxin |
10 g/100 ml |
Oral suspension |
Oral use |
100 mg/ml |
|||||||||
|
Ciproxin |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Norway |
|
Ciproxin |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciproxin |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxin |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
Ciproxin |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Poland |
|
Ciprobay Uro |
100 mg |
Film-coated tablet |
Oral use |
100 mg |
|||||||
|
Ciprobay |
250 mg |
Film-coated tablet |
Oral use |
250 mg |
|||||||||
|
Ciprobay |
500 mg |
Film-coated tablet |
Oral use |
500 mg |
|||||||||
|
Ciprobay |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Portugal |
|
Ciproxina |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
Ciproxina |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxina |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
Ciproxina OD |
500 mg |
Modified release tablets |
Oral use |
500 mg |
|||||||||
|
Ciproxina OD |
1 000 mg |
Modified release tablets |
Oral use |
1 000 mg |
|||||||||
|
Ciproxina |
10 g/100 ml |
Oral suspension |
Oral use |
100 mg/ ml |
|||||||||
|
Ciproxina |
5 g/100 ml |
Oral suspension |
Oral use |
50 mg/ml |
|||||||||
|
Ciproxina |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxina |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Romania |
|
Ciprobay |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||
|
Ciprobay |
200 mg/ 100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay |
400 mg/ 200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay XR |
500 mg |
Modified release tablets |
Oral use |
500 mg |
|||||||||
|
Ciprobay XR |
1 000 mg |
Modified release tablets |
Oral use |
1 000 mg |
|||||||||
|
Ciproxin |
5 g/100 ml |
Oral suspension |
Oral use |
50 mg/ml |
|||||||||
|
Ciproxin |
10 g/100 ml |
Oral suspension |
Oral use |
100 mg/ml |
|||||||||
|
Slovak Republic |
|
Ciprobay |
250 mg |
Film-coated tablet |
Oral use |
250 mg |
|||||||
|
Ciprobay |
500 mg |
Film-coated tablet |
Oral use |
500 mg |
|||||||||
|
Ciprobay |
750 mg |
Film-coated tablet |
Oral use |
750 mg |
|||||||||
|
Ciprobay |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Slovenia |
|
Ciprobay |
250 mg |
Film-coated tablet |
Oral use |
250 mg |
|||||||
|
Ciprobay |
500 mg |
Film-coated tablet |
Oral use |
500 mg |
|||||||||
|
Ciprobay |
750 mg |
Film-coated tablet |
Oral use |
750 mg |
|||||||||
|
Ciprobay |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciprobay |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Spain |
|
BAYCIP |
250 mg |
Film-coated tablets |
Oral use |
250 mg |
|||||||
|
BAYCIP |
500 mg |
Film-coated tablets |
Oral use |
500 mg |
|||||||||
|
BAYCIP |
750 mg |
Film-coated tablets |
Oral use |
750 mg |
|||||||||
|
BAYCIP |
250 mg |
Oral suspension (in single dose sachets) |
Oral use |
250 mg |
|||||||||
|
BAYCIP |
500 mg |
Oral suspension (in single dose sachets) |
Oral use |
500 mg |
|||||||||
|
BAYCIP |
10 g/100 ml |
Oral suspension |
Oral use |
100 mg/ml |
|||||||||
|
Sweden |
|
Ciproxin |
250 mg |
Film-coated tablet |
Oral use |
250 mg |
|||||||
|
Ciproxin |
500 mg |
Film-coated tablet |
Oral use |
500 mg |
|||||||||
|
Ciproxin |
750 mg |
Film-coated tablet |
Oral use |
750 mg |
|||||||||
|
Ciproxin |
5 g/100 ml |
Oral suspension |
Oral use |
50 mg/ml |
|||||||||
|
Ciproxin |
10 g/100 ml |
Oral suspension |
Oral use |
100 mg/ml |
|||||||||
|
Ciproxin |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
United Kingdom |
Trading as: Bayer plc Bayer Schering Pharma |
Ciproxin |
100 mg |
Film-coated tablet |
Oral use |
100 mg |
|||||||
|
Ciproxin |
250 mg |
Film-coated tablet |
Oral use |
250 mg |
|||||||||
|
Ciproxin |
500 mg |
Film-coated tablet |
Oral use |
500 mg |
|||||||||
|
Ciproxin |
750 mg |
Film-coated tablet |
Oral use |
750 mg |
|||||||||
|
Ciproxin |
250 mg/5 ml |
Oral suspension |
Oral use |
50 mg/ml |
|||||||||
|
Ciproxin |
500 mg/5 ml |
Oral suspension |
Oral use |
100 mg/ml |
|||||||||
|
Ciproxin |
100 mg/50 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
200 mg/100 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
|||||||||
|
Ciproxin |
400 mg/200 ml |
Solution for infusion |
Intravenous use |
2 mg/ml |
ANNEX V
LIST OF THE PRODUCT NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND ICELAND
|
Member State |
MAH name and address |
INN |
Product Name |
Strength |
Pharmaceutical Form |
Route of administration |
||||||
|
Austria |
|
Moxifloxacin hydrochloride |
Actira 400 mg — Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Austria |
|
Moxifloxacin hydrochloride |
Octegra 400 mg — Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Austria |
|
Moxifloxacin hydrochloride |
Avelox 400 mg — Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Bulgaria |
|
Moxifloxacin |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Moxifloxacin hydrochloride |
Actira 400 mg |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Moxifloxacin hydrochloride |
Avelox 400 mg |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Belgium |
|
Moxifloxacin hydrochloride |
Proflox 400 mg |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Cyprus |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Czech Republic |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Moxifloxacin hydrochloride |
Avalox 400 mg Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Moxifloxacin hydrochloride |
Octegra 400 mg Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Moxifloxacin hydrochloride |
Actira 400 mg Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
Moxifloxacin hydrochloride |
Actimax 400 mg Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Denmark |
|
Moxifloxacin hydrochloride |
Actira |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Denmark |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Denmark |
|
Moxifloxacin |
Infekt |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Denmark |
|
Moxifloxacin |
Moxiflaxacine ‘Teva’ |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Estonia |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Greece |
|
Moxifloxacin |
Octegra |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Greece |
|
Moxifloxacin |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Greece |
|
Moxifloxacin |
Proflox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Spain |
|
Moxifloxacin hydrochloride |
Actira 400 mg comprimidos recubiertos con película |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Spain |
|
Moxifloxacin hydrochloride |
Octegra 400 mg comprimidos recubiertos con película |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Spain |
|
Moxifloxacin hydrochloride |
Havelox 400 mg comprimidos recubiertos con película |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Spain |
|
Moxifloxacin hydrochloride |
Proflox 400 mg comprimidos recubiertos con película |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Finland |
|
Moxifloxacin hydrochloride |
Actira |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Finland |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
France |
|
Moxifloxacin hydrochloride |
Izilox 400 mg, comprimé pelliculé |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
France |
|
Moxifloxacin hydrochloride |
Octegra 400 mg, comprimé pelliculé |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Hungary |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Iceland |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Moxifloxacin hydrochloride |
Avalox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Moxifloxacin hydrochloride |
Proflox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Moxifloxacin hydrochloride |
Octegra |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
Moxifloxacin hydrochloride |
Actira |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Ireland |
|
Moxafloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Lithuania |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Moxifloxacin hydrochloride |
Actira |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Luxembourg |
|
Moxifloxacin hydrochloride |
Proflox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Latvia |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Malta |
|
Moxifloxacin hydrochloride |
Avalox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Netherlands |
|
Moxifloxacin hydrochloride |
Avelox 400 mg tabletten |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Netherlands |
|
Moxifloxacin hydrochloride |
Octegra 400 mg tabletten |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Poland |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Moxifloxacin hydrochloride |
Actira |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Portugal |
|
Moxifloxacin hydrochloride |
Proflox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Romania |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Sweden |
|
Moxifloxacin hydrochloride |
Avelox |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Sweden |
|
Moxifloxacin hydrochloride |
Actira |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Sweden |
|
Moxifloxacin hydrochloride |
Octegra |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Slovenia |
|
Moxifloxacin hydrochloride |
Avelox 400 mg filmsko obložene tablete |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
Slovakia |
|
Moxifloxacin hydrochloride |
Avelox 400 |
400 mg |
Film-coated tablet |
Oral use |
||||||
|
United Kingdom |
|
Moxifloxacin hydrochloride |
Avelox 400 mg tablets |
400 mg |
Film-coated tablet |
Oral use |
ANNEX VI
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Name |
Strength |
Pharmaceutical Form |
Route of administration |
||||
|
Denmark |
|
|
Ribavirin IQUR Capsules |
200 mg |
Capsule, hard |
Oral use |
||||
|
Ribavirin IQUR Tablets |
200/400/600 mg |
Film-coated tablet |
Oral use |
||||||
|
France |
|
|
Ribavirin IQUR Capsules |
200 mg |
Capsule, hard |
Oral use |
||||
|
Ribavirin IQUR Tablets |
200/400/600 mg |
Film-coated tablet |
Oral use |
||||||
|
Germany |
|
|
Ribavirin IQUR Capsules |
200 mg |
Capsule, hard |
Oral use |
||||
|
Ribavirin IQUR Tablets |
200/400/600 mg |
Film-coated tablet |
Oral use |
||||||
|
Greece |
|
|
Ribavirin IQUR Capsules |
200 mg |
Capsule, hard |
Oral use |
||||
|
Ribavirin IQUR Tablets |
200/400/600 mg |
Film-coated tablet |
Oral use |
||||||
|
Ireland |
|
|
Ribavirin IQUR capsules |
200 mg |
Capsule, hard |
Oral use |
||||
|
Ribavirin IQUR tablets |
200/400/600 mg |
Film-coated tablet |
Oral use |
||||||
|
Italy |
|
|
Ribavirin IQUR |
200 mg |
Capsule, hard |
Oral use |
||||
|
Ribavirin IQUR |
200/400/600 mg |
Film-coated tablet |
Oral use |
||||||
|
Poland |
|
|
Ribavirin IQUR |
200 mg |
Capsule, hard |
Oral use |
||||
|
Ribavirin IQUR |
200/400/600 mg |
Film-coated tablet |
Oral use |