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Document 52006XC1124(03)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.10.2006 to 31.10.2006 (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 1.10.2006 to 31.10.2006 (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 1.10.2006 to 31.10.2006 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
OJ C 287, 24.11.2006, p. 12–19
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
|
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/12 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.10.2006 to 31.10.2006
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2006/C 287/04)
— Issuing, maintenance or modification of a national marketing authorisation
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|
11.10.2006 |
Doxastad (doxazosin) Art 29 |
See Annex I |
See Annex I |
13.10.2006 |
|
11.10.2006 |
Doxazosin Winthrop (doxazosin) Art 29 - |
See Annex II |
See Annex II |
13.10.2006 |
|
11.10.2006 |
Cardoreg (doxazosin) Art 29 |
See Annex III |
See Annex III |
13.10.2006 |
|
11.10.2006 |
Doxagamma (doxazosin) Art 29 |
See Annex IV |
See Annex IV |
13.10.2006 |
|
11.10.2006 |
Doxazosin Retard Arrow (doxazosin) Art 29 |
See Annex V |
See Annex V |
13.10.2006 |
|
13.10.2006 |
Cobactan DC Art 39 |
See Annex VI |
See Annex VI |
16.10.2006 |
(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 FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
|
Estonia |
|
|
Doxalfa 4 mg toimeainet prolongeeritult vabastavad tabletid |
4 mg |
Prolonged-release tablet |
Oral |
|||||||
|
Latvia |
|
|
Doxalfa 4 mg ilgstošās darbības tabletes |
4 mg |
Prolonged-release tablet |
Oral |
|||||||
|
Lithuania |
|
|
Doxalfa 4 mg pailginto atpalaidavimo tabletės |
4 mg |
Prolonged-release tablet |
Oral |
|||||||
|
Netherlands |
|
|
Doxazosine retard CF 4mg, tabletten met gereguleerde afgifte |
4 mg |
Prolonged-release tablet |
Oral |
|||||||
|
Spain |
|
|
DOXAZOSINA NEO STADA 4 mg comprimidos de liberación prolongada EEG |
4 mg |
Prolonged-release tablet |
Oral |
|||||||
|
Sweden |
|
|
Doxastad 4mg depottablett |
4 mg |
Prolonged-release tablet |
Oral |
|||||||
|
United Kingdom |
|
|
Doxadura XL 4 mg |
4 mg |
Prolonged-release tablet |
Oral |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
|
Denmark |
|
|
Doxazosin ‘Winthrop’ |
4 mg |
Prolonged release tablets |
Oral |
|||||||
|
Germany |
|
|
Doxazosin Winthrop 4 mg Retardtabletten |
4 mg |
Prolonged release tablets |
Oral |
|||||||
|
Hungary |
|
|
Doxazosin Winthrop 4mg Tablettes |
4 mg |
Prolonged release tablets |
Oral |
|||||||
|
Poland |
|
|
DOXAWIN XL |
4 mg |
Prolonged release tablets |
Oral |
|||||||
|
Slovakia |
|
|
Doxazosin Winthrop XL 4 mg |
4 mg |
Prolonged release tablets |
Oral |
|||||||
|
Spain |
|
|
Doxazosina WINTHROP 4 mg comprimidos de liberación prolongada EFG |
4 mg |
Prolonged release tablets |
Oral |
|||||||
|
United Kingdom |
|
|
Slocinx XL 4mg Tablets |
4 mg |
Prolonged release tablets |
Oral |
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/ MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||
|
Czech Republic |
|
|
Lansoprazol-ratiopharm 4 mg Hartkapseln |
4 mg |
Prolonged release tablets |
Oral |
|||||
|
Denmark |
|
|
Cardoreg 4 mg depottabletter |
4 mg |
Prolonged release tablets |
Oral |
|||||
|
Hungary |
|
|
Doxazosin-ratiopharm retard 4 mg tabletta |
4 mg |
Prolonged release tablets |
Oral |
|||||
|
Poland |
|
|
Doxazosin-ratiopharm retard PR4 |
4 mg |
Prolonged release tablets |
Oral |
|||||
|
Slovakia |
|
|
Doxazosin-ratiopharm retard 4 mg |
4 mg |
Prolonged release tablets |
Oral |
|||||
|
United Kingdom |
|
|
DoxaCard XL 4 mg prolonged release tablets |
4 mg |
Prolonged release tablets |
Oral |
ANNEX IV
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
|
Denmark |
|
|
Doxagamma |
4mg |
Prolonged-release tablet |
oral |
|||||||
|
United Kingdom |
|
|
Doxzogen XL 4mg Tablets |
4mg |
Prolonged-release tablet |
oral |
ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
|
Denmark |
|
|
Doxazosin ‘Arrow’, 4mg depottabletter |
4 mg |
Prolonged release tablets |
Oral |
|||||||
|
Portugal |
|
|
Doxazosin Arrow 4mg comprimido de libertaçao prolongada |
4 mg |
Prolonged release tablets |
Oral |
|||||||
|
Slovenia |
|
|
Doksazosin Arrow 4mg tablete s podaljšanim sproščanjem |
4 mg |
Prolonged release tablets |
Oral |
|||||||
|
United Kingdom |
|
|
Cardozin XL 4mg |
4 mg |
Prolonged release tablets |
Oral |
ANNEX VI
LIST OF NAMES, PHARMACEUTICAL FORM OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Product invented name |
Pharmaceutical form |
Animal species |
Frequency |
Recommended dose |
Withdrawal period (meat and milk) |
|||||
|
Belgium |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Czech Republic |
|
Cobactan DC intramam susp. Ad us. Vet |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Germany |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Estonia |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Greece |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Spain |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
France |
|
Cobactan DC suspension intramammaire |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Ireland |
|
Cephaguard DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Italy |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Cyprus |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Latvia |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Lithuania |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Luxembourg |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Austria |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Poland |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Portugal |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Slovenia |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
Slovakia |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
|
United Kingdom |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |