Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 February 2006  to  28 February 2006 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2006-03-31
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation

C 78/20

EN

Official Journal of the European Union

31.3.2006

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 February 2006 to 28 February 2006

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2006/C 78/04)

— 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

21.2.2006

Lanzoprazol ratiopharm

See Annex I

See Annex I

21.2.2006

Lansoprazol ABZ-Pharma

See Annex II

See Annex II

23.2.2006

23.2.2006

21.2.2006

Lansoprazol CT-Arzneimittel

See Annex III

See Annex III

23.2.2006

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.

31.3.2006

EN

Official Journal of the European Union

C 78/21

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

ANNEX I

Member
State

Marketing Authorisation
Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of
administration

Austria

Belgium

—

—

ratiopharm Arznei-
mittel Vertriebs-GmbH
Albert-Schweitzer-G. 3
A-1140 Wien

Lansoprazol ‘ratiopharm’
15 mg Kapseln

Lansoprazol ‘ratiopharm’
30 mg Kapseln

ratiopharm Belgium
Rue Saint-Lambert 14
B-1120 Bruxelles/
Brussel

Lansoprazol-ratiopharm
15 mg gelules gastro-résis-
tante

Lansoprazol-ratiopharm
30 mg gelules gastro-résis-
tante

Lantrolix 15 mg entero-
kapsler, hårde

Lantrolix 30 mg entero-
kapsler, hårde

Lansoprazol ratiopharm
15 mg

Lansoprazol ratiopharm
30 mg

Lansoprazol-ratiopharm
15 mg Hartkapseln

Lansoprazol-ratiopharm
30 mg Hartkapseln

15 mg

30 mg

15 mg

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

30 mg

Gastro-resistant
capsule, hard

15 mg

30 mg

15 mg

30 mg

15 mg

30 mg

15 mg

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Lansoprazolo ratiopharm
15 mg capsule di gelatina
dura

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

ratiopharm Lda,
Portugal
Edifício Tejo, 6.o piso
Rua Quinta do
Pinheiro
P-2790-143 Carnaxide

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Lansoprazolo ratiopharm
30 mg capsule di gelatina
dura

30 mg

Gastro-resistant
capsule, hard

Lansoprazol-ratiopharm
15 mg Hartkapseln

Lansoprazol-ratiopharm
30 mg Hartkapseln

Lansoprazol ratiopharm
15 mg cápsulas gastro-
resistentes

Lansoprazol ratiopharm
30 mg cápsulas gastro-
resistentes

15 mg

30 mg

15 mg

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

30 mg

Gastro-resistant
capsule, hard

Sopranix 15 mg, entero-
kapsler, hårda

Sopranix 30 mg, entero-
kapsler, hårda

15 mg

30 mg

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Denmark

—

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Finland

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

—

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Germany

Italy

Luxem-
bourg

Portugal

—

—

—

—

Sweden

—

C 78/22

EN

Official Journal of the European Union

31.3.2006

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

ANNEX II

Member
State

Marketing Authorisation
Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Finland

ratiopharm GmbH
Graf-Arco-Str. 3
D-89075 Ulm

—

Germany

—

ratiopharm GmbH
Graf-Arco-Str. 3
D-89075 Ulm

Lansoprazol AbZ-Pharma
15 mg

Lansoprazol AbZ-Pharma
30 mg

Lansoprazol AbZ 15 mg
Hartkapseln

Lansoprazol AbZ 30 mg
Hartkapseln

15 mg

30 mg

15 mg

30 mg

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Route of
administration

Oral use

Oral use

Oral use

Oral use

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

ANNEX III

Member
State

Marketing Authorisation
Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Finland

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

—

Germany

—

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Lansoprazol CT-Arznei-
mittel 15 mg

Lansoprazol CT-Arznei-
mittel 30 mg

Lansoprazol-CT 15 mg
Hartkapseln

Lansoprazol-CT 30 mg
Hartkapseln

15 mg

30 mg

15 mg

30 mg

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Gastro-resistant
capsule, hard

Route of
administration

Oral use

Oral use

Oral use

Oral use