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Document 52005XC1028(02)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2005 to 30 September 2005(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 September 2005 to 30 September 2005(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 September 2005 to 30 September 2005(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
ĠU C 268, 28.10.2005, p. 7–9
(ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
|
28.10.2005 |
EN |
Official Journal of the European Union |
C 268/7 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2005 to 30 September 2005
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2005/C 268/03)
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 |
|
15.9.2005 |
Lansopon |
See Annex I |
See Annex I |
19.9.2005 |
|
15.9.2005 |
Lansoprazol HEXAL |
See Annex II |
See Annex II |
19.9.2005 |
(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, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing authorisation holder |
Applicant |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
|||
|
Belgium |
— |
|
Lansoprazole BEXAL 15 mg gélules gastro-resistantes |
15 mg |
Gastro-resistant capsule, hard |
Oral use |
|||
|
Lansoprazole BEXAL 30 mg gélules gastro-resistantes |
30 mg |
Gastro-resistant capsule, hard |
Oral use |
||||||
|
Lansoprazol HEXAL |
30 mg |
Gastro-resistant capsule, hard |
Oral use |
||||||
|
Germany |
— |
|
Lansoprazol HEXAL 15 mg Hartkapseln |
15 mg |
Gastro-resistant capsule, hard |
Oral use |
|||
|
Lansoprazol HEXAL 30 mg Hartkapseln |
30 mg |
Gastro-resistant capsule, hard |
Oral use |
||||||
|
Finland |
|
— |
Lansopon 15mg |
15 mg |
Gastro-resistant capsule, hard |
Oral use |
|||
|
Lansopon 30 mg |
30 mg |
Gastro-resistant capsule, hard |
Oral use |
||||||
|
Luxembourg |
— |
|
Lansoprazol HEXAL 15 mg Hartkapseln |
15 mg |
Gastro-resistant capsule, hard |
Oral use |
|||
|
Lansoprazol HEXAL 30 mg Hartkapseln |
30 mg |
Gastro-resistant capsule, hard |
Oral use |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing authorisation holder |
Applicant |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
|||
|
Austria |
— |
|
Lansohexal 15 mg — Hartkapseln |
15 mg |
Gastro-resistant capsule, hard |
Oral use |
|||
|
Lansohexal 30 mg — Hartkapseln |
30 mg |
Gastro-resistant capsule, hard |
Oral use |
||||||
|
Denmark |
— |
|
Lansoprazol HEXAL |
15 mg |
Gastro-resistant capsule, hard |
Oral use |
|||
|
Lansoprazol HEXAL |
30 mg |
Gastro-resistant capsule, hard |
Oral use |
||||||
|
Germany |
— |
|
Lansohexal 15 mg Hartkapseln |
15 mg |
Gastro-resistant capsule, hard |
Oral use |
|||
|
Lansohexal 30 mg Hartkapseln |
30 mg |
Gastro-resistant capsule, hard |
Oral use |
||||||
|
Finland |
|
— |
Lansoprazol HEXAL 15mg |
15 mg |
Gastro-resistant capsule, hard |
Oral use |
|||
|
Lansoprazol HEXAL 30 mg |
30 mg |
Gastro-resistant capsule, hard |
Oral use |
||||||
|
Sweden |
— |
|
Lansocid |
15 mg |
Gastro-resistant capsule, hard |
Oral use |
|||
|
Lansocid |
30 mg |
Gastro-resistant capsule, hard |
Oral use |