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)
Date: 2005-10-28
Institutions: European Commission
Subjects: market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation

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

15.9.2005

Lansopon

See Annex I

15.9.2005

Lansoprazol HEXAL

See Annex II

See Annex I

See Annex II

Date of
notification

19.9.2005

19.9.2005

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

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

ANNEX I

Member State

Marketing authorisation holder

Applicant

Invented name

Strength

Pharmaceutical form

Route of
administration

Belgium

Germany

Finland

—

—

HEXAL AG
Industriestraße 25
DE-83607 Holzkirchen

Lansoprazole BEXAL 15 mg gélules gastro-resistantes 15 mg

Lansoprazole BEXAL 30 mg gélules gastro-resistantes 30 mg

Lansoprazol HEXAL

30 mg

HEXAL AG
Industriestraße 25
DE-83607 Holzkirchen

Lansoprazol HEXAL 15 mg Hartkapseln

15 mg

Lansoprazol HEXAL 30 mg Hartkapseln

30 mg

HEXAL AG
Industriestraße 25
DE-83607 Holzkirchen

—

Lansopon 15mg

Lansopon 30 mg

Luxembourg

—

HEXAL AG
Industriestraße 25
DE-83607 Holzkirchen

Lansoprazol HEXAL 15 mg Hartkapseln

Lansoprazol HEXAL 30 mg Hartkapseln

30 mg

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

15 mg

30 mg

15 mg

C

2
6
8
/
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
8
1
0
2
0
0
5

.

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

ANNEX II

Member State

Marketing authorisation holder

Applicant

Invented name

Strength

Pharmaceutical form

Route of
administration

.

2
8
1
0
2
0
0
5

.

Austria

Denmark

Germany

Finland

—

—

—

HEXAL AG
Industriestraße 25
DE-83607 Holzkirchen

Lansohexal 15 mg — Hartkapseln

Lansohexal 30 mg — Hartkapseln

HEXAL AG
Industriestraße 25
DE-83607 Holzkirchen

Lansoprazol HEXAL

Lansoprazol HEXAL

HEXAL AG
Industriestraße 25
DE-83607 Holzkirchen

Lansohexal 15 mg Hartkapseln

Lansohexal 30 mg Hartkapseln

HEXAL AG
Industriestraße 25
DE-83607 Holzkirchen

—

Lansoprazol HEXAL 15mg

Lansoprazol HEXAL 30 mg

Sweden

—

HEXAL AG
Industriestraße 25
DE-83607 Holzkirchen

Lansocid

Lansocid

15 mg

30 mg

15 mg

30 mg

15 mg

30 mg

15 mg

30 mg

15 mg

30 mg

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

Gastro-resistant
hard

capsule,

Oral use

E
N

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

capsule,

Oral use

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C
2
6
8
/
9