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Document 52007XC0629(02)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 2007 (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 May 2007 to 31 May 2007 (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 May 2007 to 31 May 2007 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
OJ C 144, 29.6.2007, p. 11–21
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
29.6.2007 |
EN |
Official Journal of the European Union |
C 144/11 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 2007
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2007/C 144/07)
— 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 |
|
22.5.2007 |
Doxyprex |
See Annex I |
See Annex I |
24.5.2007 |
|
22.5.2007 |
Thelin |
This Decision is addressed to the Member States |
This Decision is addressed to the Member States |
24.5.2007 |
|
29.5.2007 |
Xefo |
See Annex II |
See Annex II |
30.5.2007 |
|
30.5.2007 |
Remicade |
This Decision is addressed to the Member States |
This Decision is addressed to the Member States |
31.5.2007 |
— 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 |
|
2.5.2007 |
Alendros 70 |
See Annex III |
See Annex III |
4.5.2007 |
(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 PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
|
Member State |
Applicant or Marketing Authorisation Holder |
Product invented name |
Pharmaceutical form |
Strength |
Animal species |
Frequency and route of administration |
Recommended dose |
|||
|
Belgium, Czech Republic, Germany, Greece, Spain, France, Italy, The Netherlands, Poland, Portugal and Slovakia |
|
DOXYPREX |
Premix |
100 mg/g |
Pigs (after weaning) |
In feed use |
10 mg/kg .bw |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
Content |
||||
|
Austria |
|
Artok |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Lornox |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Artok |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Lornoxicam ‘Nycomed’ |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Belgium |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Acute |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Bulgaria |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Czech Republic |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Denmark |
|
Lornoxicam ‘Nycomed’ |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Lornoxicam ‘Nycomed’ |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Lornoxicam ‘Nycomed’ |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Estonia |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Germany |
|
Lornoxicam ‘Nycomed’ |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Telos |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Lornoxicam ‘Nycomed’ |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Telos |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Greece |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Hungary |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Italy |
|
Taigalor |
8 mg |
Film-coated tablet |
Oral |
8 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Taigalor |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Latvia |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Lithuania |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Luxembourg |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Acute |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Portugal |
|
Acabel |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Bosporon |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Acabel |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Bosporon |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Acabel Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Bosporon Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Acabel |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Bosporon |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Romania |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Spain |
|
Acabel |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Bosporon |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Acabel |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Bosporon |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Acabel Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Bosporon Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Acabel |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Sweden |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Akut |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
United Kingdom |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
||||
|
Czech Republic |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Estonia |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Hungary |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Latvia |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Lithuania |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Poland |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Slovakia |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |