Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.7.2006 to 31.7.2006 (Decisions taken pursuant to Article 34 of Directive 2001/83/ECor Article 38 of Directive 2001/82/EC)
Date: 2006-09-08
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

8.9.2006

EN

Official Journal of the European Union

C 217/13

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1.7.2006 to 31.7.2006

(Decisions

taken pursuant

to Article 34 of Directive 2001/83/EC (1)or Article 38 of Directive

2001/82/EC (2))

(2006/C 217/04)

— 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

4.7.2006

STAMARIL

4.7.2006

Viani Evohaler

See Annex I

See Annex II

4.7.2006

Seretide Diskus

See Annex III

4.7.2006

Viani Diskus

See Annex IV

4.7.2006

Seretide Evohaler

See Annex V

See Annex I

See Annex II

See Annex III

See Annex IV

See Annex V

Date of
notification

6.7.2006

5.7.2006

5.7.2006

5.7.2006

5.7.2006

(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 FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS,
ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

Austria

Belgium

Czech Republic

Denmark

Estonia

Finland

Sanofi Pasteur MSD SNC
8, rue Jonas Salk
F-69007 Lyon
Tel: (33) 437 28 40 00
Fax: (33) 437 28 44 00

Sanofi Pasteur MSD SA
Avenue Jules Bordet 13
B-1140 Bruxelles
Tel: (32-2) 726 95 84
Fax: (32-2) 726 85 84

Aventis Pasteur SA
2, avenue Pont Pasteur
F-69007 Lyon
Tel: (33) 437 37 01 00
Fax: (33) 437 37 77 37

Sanofi Pasteur MSD SA
Avenue Jules Bordet 13
B-1140 Bruxelles
Tel: (32-2) 72 69 584
Fax: (32-2) 72 68 584

Aventis Pasteur SA
2, avenue Pont Pasteur
F-69007 Lyon
Tel: (33) 437 37 01 00
Fax: (33) 437 37 77 37

Sanofi Pasteur MSD SA
Avenue Jules Bordet 13
B-1140 Bruxelles
Tel: (32-2) 726 95 84
Fax: (32-2) 726 85 84

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL Pasteur

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL Pasteur

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

C

2
1
7
/
1
4

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

.

.

8
9
2
0
0
6

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

France

Germany

Hungary

Ireland

Italy

Latvia

Lithuania

Sanofi Pasteur MSD SNC
8, rue Jonas Salk
F-69007 Lyon
Tel: (33) 437 28 40 00
Fax: (33) 437 28 44 00

Sanofi Pasteur MSD GmbH
Paul-Ehrlich-Str. 1
D-69181 Leimen
Tel: (49) 62 24 59 40
Fax: (49) 622 45 94 33

Aventis Pasteur SA
2, avenue Pont Pasteur
F-69007 Lyon
Tel: (33) 437 37 01 00
Fax: (33) 437 37 77 37

Sanofi Pasteur MSD Ltd
Belgard Road
Tallaght
Dublin 24
Ireland
Tel: (35) 314 04 16 88
Fax: (35) 314 04 16 87

Sanofi Pasteur MSD SNC
8, rue Jonas Salk
F-69007 Lyon
Tel: (33) 437 28 40 00
Fax: (33) 437 28 44 00

Aventis Pasteur SA
2, avenue Pont Pasteur
F-69007 Lyon
Tel: (33) 437 37 01 00
Fax: (33) 437 37 77 37

Aventis Pasteur SA
2, avenue Pont Pasteur
F-69007 Lyon
Tel: (33) 437 37 01 00
Fax: (33) 437 37 77 37

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL Pasteur

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL Pasteur

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL Pasteur

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL Pasteur

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

.

.

8
9
2
0
0
6

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

C
2
1
7
/
1
5

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

Luxemburg

Poland

Portugal

Slovakia

Spain

Sweden

The Netherlands

Sanofi Pasteur MSD SA
Avenue Jules Bordet 13
B-1140 Bruxelles
Tel: (32-2) 726 95 84
Fax: (32-2) 726 85 84

Aventis Pasteur SA
2, avenue Pont Pasteur
F-69007 Lyon
Tel: (33) 437 37 01 00
Fax: (33) 437 37 77 37

Sanofi Pasteur MSD SNC
8, rue Jonas Salk
F-69007 Lyon
Tel: (33) 437 28 40 00
Fax: (33) 437 28 44 00

Aventis Pasteur SA
2, avenue Pont Pasteur
F-69007 Lyon
Tel: (33) 437 37 01 00
Fax: (33) 437 37 77 37

Sanofi Pasteur MSD SA
Edificio Cuzco IV
Paseo de la Castellana, 141
E-28046 Madrid
Tel: (34) 913 71 78 00
Fax: (34) 913 71 78 88

Sanofi Pasteur MSD SA
Avenue Jules Bordet 13
B-1140 Bruxelles
Tel: (32-2) 726 95 84
Fax: (32-2) 726 85 84

Sanofi-Pasteur MSD SA
Avenue Jules Bordet 13
B-1140 Bruxelles
Tel: (32-2) 726 85 84
Fax: (32-2) 726 85 84

STAMARIL Pasteur

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL Pasteur

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL Pasteur

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL Pasteur

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

C

2
1
7
/
1
6

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

.

.

8
9
2
0
0
6

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

United Kingdom

Iceland

Norway

Sanofi Pasteur MSD Limited
Mallards Reach, Bridge Road
Maidenhead
Berkshire SL6 1QP
United Kingdom
Tel: (44) 16 28 78 52 91
Fax: (44) 16 28 58 81 66

Sanofi Pasteur MSD SA
Avenue Jules Bordet 13
B-1140 Bruxelles
Tel: (32-2) 726 85 84
Fax: (32-2) 726 85 84

Sanofi Pasteur MSD SA
Avenue Jules Bordet 13
B-1140 Bruxelles
Tel: (32-2) 726 85 84
Fax: (32-2) 726 85 84

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

STAMARIL

Not less than 1 000 LD50 units

Powder and solvent for suspension for
injection

Subcutaneous use (preferred) or intra-
muscular use

.

.

8
9
2
0
0
6

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

C
2
1
7
/
1
7

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

ANNEX II

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Austria

Austria

Austria

Belgium

Belgium

Belgium

Finland

Finland

Finland

France

Allen Pharmazeutika Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Allen Pharmazeutika Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Allen Pharmazeutika Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24
FIN-02231 Espoo

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24
FIN-02231 Espoo

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24
FIN-02231 Espoo

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

Viani forte Dosieraerosol

25/250

Pressurised inhalation, suspension

Inhalation use

Viani standard Dosieraerosol

25/125

Pressurised inhalation, suspension

Inhalation use

Viani junior Dosieraerosol

25/50

Pressurised inhalation, suspension

Inhalation use

Viani 25/125

25/125

Pressurised inhalation, suspension

Inhalation use

Viani 25/250

25/250

Pressurised inhalation, suspension

Inhalation use

Viani 25/50

25/50

Pressurised inhalation, suspension

Inhalation use

Viani Evohaler

25/125

Pressurised inhalation, suspension

Inhalation use

Viani Evohaler

25/250

Pressurised inhalation, suspension

Inhalation use

Viani Evohaler

25/50

Pressurised inhalation, suspension

Inhalation use

Viani

25/50

Pressurised inhalation, suspension

Inhalation use

C

2
1
7
/
1
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

.

.

8
9
2
0
0
6

France

France

Germany

Germany

Germany

Ireland

Ireland

Ireland

Italy

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

25/125

Pressurised inhalation, suspension

Inhalation use

.

.

8
9
2
0
0
6

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

Viani

Viani

25/250

Pressurised inhalation, suspension

Inhalation use

E
N

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

Viani mite Dosier-Aerosol FCKW-frei
25 mg/50 mg
Druckgasinhalation,
Suspension

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

Dosier-Aerosol

FCKW-frei
Viani
25 mg/125 mg Druckgasinhalation,
Suspension

GlaxoSmithKline GmbH & Co. KG
Theresienhöhe 11
D-80339 München

Viani forte Dosier-Aerosol FCKW-frei
25 mg/250 mg Druckgasinhalation,
Suspension

25/50

Pressurised inhalation, suspension

Inhalation use

25/125

Pressurised inhalation, suspension

Inhalation use

25/250

Pressurised inhalation, suspension

Inhalation use

GlaxoSmithKline (Ireland) Limited
(trading as: Allen & Hanburys)
Stonemasons Way
Rathfarnham
Dublin 16
Irlande

GlaxoSmithKline (Ireland) Limited
(trading as: Allen & Hanburys)
Stonemasons Way
Rathfarnham
Dublin 16
Irlande

GlaxoSmithKline (Ireland) Limited
(trading as: Allen & Hanburys)
Stonemasons Way
Rathfarnham
Dublin 16
Irlande

Menarini International Operations
Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg

Viani Evohaler

25/50

Pressurised inhalation, suspension

Inhalation use

Viani Evohaler

25/125

Pressurised inhalation, suspension

Inhalation use

Viani Evohaler

25/250

Pressurised inhalation, suspension

Inhalation use

Aliflus

25/50

Pressurised inhalation, suspension

Inhalation 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
1
7
/
1
9

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Italy

Italy

Luxembourg

Luxembourg

Luxembourg

Portugal

Portugal

Portugal

Spain

Spain

Menarini International Operations
Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg

Menarini International Operations
Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg

Aliflus

Aliflus

25/125

Pressurised inhalation, suspension

Inhalation use

25/250

Pressurised inhalation, suspension

Inhalation use

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

Alodial Farmacêutica, Lda.
Estrada Marco do Grilo
Zemouto
P-2830 Coina

Alodial Farmacêutica, Lda.
Estrada Marco do Grilo
Zemouto
P-2830 Coina

Alodial Farmacêutica, Lda.
Estrada Marco do Grilo
Zemouto
P-2830 Coina

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

Viani 25/50

25/50

Pressurised inhalation, suspension

Inhalation use

Viani 25/125

25/125

Pressurised inhalation, suspension

Inhalation use

Viani 25/250

25/250

Pressurised inhalation, suspension

Inhalation use

Veraspir Inalador

25/50

Pressurised inhalation, suspension

Inhalation use

Veraspir Inalador

25/125

Pressurised inhalation, suspension

Inhalation use

Veraspir Inalador

25/250

Pressurised inhalation, suspension

Inhalation use

Brisair 25/125

25/125

Pressurised inhalation suspension

Inhalation use

Brisair 25/250

25/250

Pressurised inhalation suspension

Inhalation use

C

2
1
7
/
2
0

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

.

.

8
9
2
0
0
6

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Brisair 25/50

25/50

Pressurised inhalation suspension

Inhalation use

.

.

8
9
2
0
0
6

Spain

Sweden

Sweden

Sweden

United Kingdom

United Kingdom

United Kingdom

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

Glaxo Wellcome UK Limited, trading
as Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Glaxo Wellcome UK Limited, trading
as Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Glaxo Wellcome UK Limited, trading
as Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Viani Evohaler mite

25/50

Pressurised inhalation, suspension

Inhalation use

E
N

Viani Evohaler

25/125

Pressurised inhalation, suspension

Inhalation use

Viani Evohaler forte

25/250

Pressurised inhalation, suspension

Inhalation use

Viani 50 Evohaler

25/50

Pressurised inhalation suspension

Inhalation use

Viani 125 Evohaler

25/125

Pressurised inhalation suspension

Inhalation use

Viani 250 Evohaler

50/250

Pressurised inhalation suspension

Inhalation 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
1
7
/
2
1

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

ANNEX III

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Austria

Austria

Austria

Belgium

Belgium

Belgium

Denmark

Denmark

Denmark

Finland

Glaxo SmithKline Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Glaxo SmithKline Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Glaxo SmithKline Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24
FIN-02231 Espoo

Seretide Diskus forte

50/500

Inhalation powder, predispensed

Inhalation use

Seretide Diskus standard

50/250

Inhalation powder, predispensed

Inhalation use

Seretide Diskus junior

50/100

Inhalation powder, predispensed

Inhalation use

Seretide 50/100 Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Seretide 50/250 Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Seretide 50/500 Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Seretide

50/100

Inhalation powder, predispensed

Inhalation use

Seretide

50/250

Inhalation powder, predispensed

Inhalation use

Seretide

50/500

Inhalation powder, predispensed

Inhalation use

Seretide Diskus

50/100

Inhalation powder, predispensed

Inhalation use

C

2
1
7
/
2
2

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

.

.

8
9
2
0
0
6

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Finland

Finland

France

France

France

Germany

Germany

Germany

Greece

Greece

Greece

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24
FIN-02231 Espoo

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24
FIN-02231 Espoo

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

Schwarz Pharma Deutschland GmbH
Alfred-Nobel-Str. 10
D-40789 Monheim

Schwarz Pharma Deutschland GmbH
Alfred-Nobel-Str. 10
D-40789 Monheim

Schwarz Pharma Deutschland GmbH
Alfred-Nobel-Str. 10
D-40789 Monheim

GlaxoSmithKline A.E.B.E
Leof. Kifisias 266
GR-15232 Halandri, Athens

GlaxoSmithKline A.E.B.E
Leof. Kifisias 266
GR-15232 Halandri, Athens

GlaxoSmithKline A.E.B.E
Leof. Kifisias 266
GR-15232 Halandri, Athens

Seretide Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Seretide Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Seretide Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Seretide Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Seretide Diskus

50/500

Inhalation powder, predispensed

Inhalation use

atmadisc mite 50mg/100mg
Diskus

50/100

Inhalation powder, predispensed

Inhalation use

atmadisc 50mg/250mg Diskus

50/250

Inhalation powder, predispensed

Inhalation use

atmadisc forte 50mg/500mg
Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Seretide Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Seretide Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Seretide Diskus

50/500

Inhalation powder, predispensed

Inhalation use

.

.

8
9
2
0
0
6

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

C
2
1
7
/
2
3

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Ireland

Ireland

Ireland

Italy

Italy

Italy

Luxembourg

Luxembourg

Luxembourg

GlaxoSmithKline (Ireland) Limited (trading as:
Allen & Hanbury)
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Limited (trading as:
Allen & Hanbury)
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Limited (trading as:
Allen & Hanbury)
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline S.p.A.
Via A. Fleming, 2
I-37135 Verona

GlaxoSmithKline S.p.A.
Via A. Fleming, 2
I-37135 Verona

GlaxoSmithKline S.p.A.
Via A. Fleming, 2
I-37135 Verona

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

Seretide Diskus 100

50/100

Inhalation powder, predispensed.

Inhalation use

Seretide Diskus 250

50/250

Inhalation powder, predispensed.

Inhalation use

Seretide Diskus 500

50/500

Inhalation powder, predispensed.

Inhalation use

Seretide Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Seretide Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Seretide Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Seretide 50/100 Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Seretide 50/250 Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Seretide 50/500 Diskus

50/500

Inhalation powder, predispensed

Inhalation use

C

2
1
7
/
2
4

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

.

.

8
9
2
0
0
6

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Portugal

Portugal

Portugal

Spain

Spain

Spain

Sweden

Sweden

Sweden

Glaxo Wellcome Farmacêutica, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque
Miraflores
P-1495-131 Algés

Glaxo Wellcome Farmacêutica, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque
Miraflores
P-1495-131 Algés

Glaxo Wellcome Farmacêutica, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque
Miraflores
P-1495-131 Algés

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

Seretaide Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Seretaide Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Seretaide Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Seretide Accuhaler

50/100

Inhalation powder, predispensed

Inhalation use

Seretide Accuhaler

50/250

Inhalation powder, predispensed

Inhalation use

Seretide Accuhaler

50/500

inhalation powder, predispensed

Inhalation use

Seretide Diskus mite

50/100

Inhalation powder, predispensed

Inhalation use

Seretide Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Seretide Diskus forte

50/500

inhalation powder, predispensed

Inhalation use

.

.

8
9
2
0
0
6

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

C
2
1
7
/
2
5

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

The Netherlands

The Netherlands

The Netherlands

United Kingdom

United Kingdom

United Kingdom

GlaxoSmithKline B.V.
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

GlaxoSmithKline B.V.
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

GlaxoSmithKline B.V.
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

Glaxo Wellcome UK Limited, trading as Allen &
Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Glaxo Wellcome UK Limited, trading as Allen &
Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Glaxo Wellcome UK Limited, trading as Allen &
Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Seretide 50/100 Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Seretide 50/250 Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Seretide 50/500 Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Seretide 100 Accuhaler

50/100

Inhalation powder, predispensed

Inhalation use

Seretide 250 Accuhaler

50/250

Inhalation powder, predispensed

Iinhalation use

Seretide 500 Accuhaler

50/500

Inhalation powder, predispensed

Inhalation use

C

2
1
7
/
2
6

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

.

.

8
9
2
0
0
6

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

ANNEX IV

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Austria

Austria

Austria

Belgium

Belgium

Belgium

Finland

Finland

Finland

France

Allen Pharmazeutika Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Allen Pharmazeutika Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Allen Pharmazeutika Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24
FIN-02231 Espoo

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24
FIN-02231 Espoo

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24
FIN-02231 Espoo

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

Viani Diskus forte

50/500

Inhalation powder, predispensed

Inhalation use

Viani Diskus standard

50/250

Inhalation powder, predispensed

Inhalation use

Viani Diskus junior

50/100

Inhalation powder, predispensed

Inhalation use

Viani 50/100 Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Viani 50/250 Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Viani 50/500 Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Viani Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Viani Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Viani Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Viani Diskus

50/100

Inhalation powder, predispensed

Inhalation use

.

.

8
9
2
0
0
6

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

C
2
1
7
/
2
7

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

France

France

Germany

Germany

Germany

Ireland

Ireland

Ireland

Italy

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

GlaxoSmithKline GmbH & Co KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline GmbH & Co KG
Theresienhöhe 11
D-80339 München

GlaxoSmithKline (Ireland) Limited (trading as:
Allen & Hanburys)
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Limited (trading as:
Allen & Hanburys)
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

GlaxoSmithKline (Ireland) Limited (trading as:
Allen & Hanburys)
Stonemasons Way
Rathfarnham
Dublin 16
Ireland

Menarini International Operations Luxem-
bourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg

Viani Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Viani Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Viani mite 50 mg/100 mg Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Viani 50 mg/250 mg Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Viani forte 50 mg/500 mg Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Viani Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Viani Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Viani Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Aliflus Diskus

50/100

Inhalation powder, predispensed

Inhalation use

C

2
1
7
/
2
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

.

.

8
9
2
0
0
6

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Italy

Italy

Luxembourg

Luxembourg

Luxembourg

Portugal

Portugal

Portugal

Spain

Spain

Menarini International Operations Luxem-
bourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg

Menarini International Operations Luxem-
bourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg

GlaxoSmithKline s.a./n.v.,
Rue du Tilleul 13,
B-1332 Genval

GlaxoSmithKline s.a./n.v.,
Rue du Tilleul 13,
B-1332 Genval

GlaxoSmithKline s.a./n.v.,
Rue du Tilleul 13,
B-1332 Genval

Alodial Farmacêutica, Lda.
Estrada Marco do Grilo
Zemouto
P-2830 Coina

Alodial Farmacêutica, Lda.
Estrada Marco do Grilo
Zemouto
P-2830 Coina

Alodial Farmacêutica, Lda.
Estrada Marco do Grilo
Zemouto
P-2830 Coina

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

Aliflus Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Aliflus Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Viani 50/100 Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Viani 50/250 Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Viani 50/500 Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Veraspir Diskus

50/100

Inhalation powder, predispensed

Inhalation use

Veraspir Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Veraspir Diskus

50/500

Inhalation powder, predispensed

Inhalation use

Brisair Accuhaler

50/100

Inhalation powder, predispensed

Inhalation use

Brisair Accuhaler

50/250

Inhalation powder, predispensed

Inhalation use

.

.

8
9
2
0
0
6

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

C
2
1
7
/
2
9

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Spain

Sweden

Sweden

Sweden

United Kingdom

United Kingdom

United Kingdom

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

Glaxo Wellcome UK Limited, trading as Allen
& Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Glaxo Wellcome UK Limited, trading as Allen
& Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Glaxo Wellcome UK Limited, trading as Allen
& Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Brisair Accuhaler 50

50/500

Inhalation powder, predispensed

Inhalation use

Viani Diskus mite

50/100

Inhalation powder, predispensed

Inhalation use

Viani Diskus

50/250

Inhalation powder, predispensed

Inhalation use

Viani Diskus forte

50/500

Inhalation powder, predispensed

Inhalation use

Viani 100 Accuhaler

50/100

Inhalation powder, predispensed

Inhalation use

Viani 250 Accuhaler

50/250

Inhalation powder, predispensed

Inhalation use

Viani 500 Accuhaler

50/500

Inhalation powder, predispensed

Inhalation use

C

2
1
7
/
3
0

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

.

.

8
9
2
0
0
6

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

ANNEX V

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Austria

Austria

Austria

Belgium

Belgium

Belgium

Denmark

Denmark

Denmark

Finland

Glaxo SmithKline Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Glaxo SmithKline Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Glaxo SmithKline Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24
FIN-02231 Espoo

Seretide forte Dosieraerosol

25/250

Pressurised inhalation, suspension

Inhalation use

Seretide standard Dosieraerosol

25/125

Pressurised inhalation, suspension

Inhalation use

Seretide junior Dosieraerosol

25/50

Pressurised inhalation, suspension

Inhalation use

Seretide 25/125

25/125

Pressurised inhalation, suspension

Inhalation use

Seretide 25/250

25/250

Pressurised inhalation, suspension

Inhalation use

Seretide 25/50

25/50

Pressurised inhalation, suspension

Inhalation use

Seretide

Seretide

Seretide

25/50

Pressurised inhalation, suspension

Inhalation use

25/125

Pressurised inhalation, suspension

Inhalation use

25/250

Pressurised inhalation, suspension

Inhalation use

Seretide Evohaler

25/125

Pressurised inhalation, suspension

Inhalation use

.

.

8
9
2
0
0
6

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

C
2
1
7
/
3
1

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Finland

Finland

France

France

France

Germany

Germany

Germany

Greece

Greece

Greece

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24
FIN-02231 Espoo

GlaxoSmithKline Oy
Piispansilta 9A
P.O. Box 24FIN-02231 Espoo

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

Laboratoire GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-roi Cedex

Seretide Evohaler

25/250

Pressurised inhalation, suspension

Inhalation use

Seretide Evohaler

25/50

Pressurised inhalation, suspension

Inhalation use

Seretide

Seretide

Seretide

25/50

Pressurised inhalation suspension

Inhalation use

25/125

Pressurised inhalation suspension

Inhalation use

25/250

Pressurised inhalation suspension

Inhalation use

Schwarz Pharma Deutschland GmbH
Alfred-Nobel-Str. 10
D-40789 Monheim

atmadisc mite Dosier-Aerosol FCKW-
frei 25 mg/50 mg Druckgasinhalation,
Suspension

Schwarz Pharma Deutschland GmbH
Alfred-Nobel-Str. 10
D-40789 Monheim

atmadisc Dosier-Aerosol
25 mg/125 mg
Suspension

FCKW-frei
Druckgasinhalation,

Schwarz Pharma Deutschland GmbH
Alfred-Nobel-Str. 10
D-40789 Monheim

atmadisc forte Dosier-Aerosol FCKW-
frei 25 mg/250 mg Druckgasinhala-
tion, Suspension

25/50

Pressurised inhalation suspension

Inhalation use

25/125

Pressurised inhalation suspension

Inhalation use

25/250

Pressurised inhalation suspension

Inhalation use

GlaxoSmithKline A.E.B.E
Leof. Kifisias 266
GR-15232 Halandri, Athens

GlaxoSmithKline A.E.B.E
Leof. Kifisias 266
GR-15232 Halandri, Athens

GlaxoSmithKline A.E.B.E
Leof. Kifisias 266
GR-15232 Halandri, Athens

Seretide Inhaler

25/250

Pressurised inhalation suspension

Inhalation use

Seretide Inhaler

25/50

Pressurised inhalation suspension

Inhalation use

Seretide Inhaler

25/125

Pressurised inhalation suspension

Inhalation use

C

2
1
7
/
3
2

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

.

.

8
9
2
0
0
6

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

25/50

Pressurised inhalation suspension

Inhalation use

.

.

8
9
2
0
0
6

Seretide

Seretide

Seretide

Iceland

Iceland

Iceland

Ireland

Ireland

Ireland

Italy

Italy

Italy

GlaxoSmithKline ehf
Thverholt 14
IS-105 Reykjavik

GlaxoSmithKline ehf
Thverholt 14
IS-105 Reykjavik

GlaxoSmithKline ehf
Thverholt 14
IS-105 Reykjavik

GlaxoSmithKline (Ireland) Limited
(trading as: Allen & Hanbury)
Stonemasons Way
Rathfarnham
Dublin 16
Irlande

GlaxoSmithKline (Ireland) Limited
(trading as: Allen & Hanbury)
Stonemasons Way
Rathfarnham
Dublin 16
Irlande

GlaxoSmithKline (Ireland) Limited
(trading as: Allen & Hanbury)
Stonemasons Way
Rathfarnham
Dublin 16
Irlande

GlaxoSmithKline S.p.A.
Via A. Fleming, 2
I-37135 Verona

GlaxoSmithKline S.p.A.
Via A. Fleming, 2
I-37135 Verona

GlaxoSmithKline S.p.A.
Via A. Fleming, 2
I-37135 Verona

25/125

Pressurised inhalation suspension

Inhalation use

E
N

25/250

Pressurised inhalation suspension

Inhalation use

Seretide 50 Evohaler

25/50

Pressurised inhalation, suspension

Inhalation use

Seretide 125 Evohaler

25/125

Pressurised inhalation, suspension

Inhalation use

Seretide 250 Evohaler

25/250

Pressurised inhalation, suspension

Inhalation use

Seretide

Seretide

Seretide

25/50

Pressurised inhalation, suspension

Inhalation use

25/125

Pressurised inhalation, suspension

Inhalation use

25/250

Pressurised inhalation, suspension

Inhalation use

O

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J
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C
2
1
7
/
3
3

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Luxembourg

Luxembourg

Luxembourg

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

GlaxoSmithKline s.a./n.v.
Rue du Tilleul 13
B-1332 Genval

Portugal

Portugal

Portugal

Spain

Spain

Spain

Glaxo Wellcome Farmacêutica, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque
Miraflores
P-1495-131 Algés

Glaxo Wellcome Farmacêutica, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque
Miraflores
P-1495-131 Algés

Glaxo Wellcome Farmacêutica, Lda.
Rua Dr. António Loureiro Borges, 3
Arquiparque
Miraflores
P-1495-131 Algés

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

GlaxoSmithKline SA
Parque Tecnologico de Madrid
Calle Severo Ochoa 2
E-28760, Tres Cantos, Madrid

Seretide 25/50

25/50

Pressurised inhalation, suspension

Inhalation use

Seretide 25/125

25/125

Pressurised inhalation, suspension

Inhalation use

Seretide 25/250

25/250

Pressurised inhalation, suspension

Inhalation use

Seretaide Inalador

25/50

Pressurised inhalation, suspension

Inhalation use

Seretaide Inalador

25/125

Pressurised inhalation, suspension

Inhalation use

Seretaide Inalador

25/250

Pressurised inhalation, suspension

Inhalation use

Seretide 25/50

25/50

Pressurised inhalation suspension

Inhalation use

Seretide 25/125

25/125

Pressurised inhalation suspension

Inhalation use

Seretide 25/250

25/250

Pressurised inhalation suspension

Inhalation use

C

2
1
7
/
3
4

E
N

O

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f
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i
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l

J
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e

E
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p
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a
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U
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n

i

.

.

8
9
2
0
0
6

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of
administration

Sweden

Sweden

Sweden

The Netherlands

The Netherlands

The Netherlands

United Kingdom

United Kingdom

United Kingdom

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline AB
Box 516
S-169 29 Solna

GlaxoSmithKline B.V.
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

GlaxoSmithKline B.V.
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

GlaxoSmithKline B.V.
Huis ter Heideweg 62
3705 LZ Zeist
Nederland

Glaxo Wellcome UK Limited, trading
as Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Glaxo Wellcome UK Limited, trading
as Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Glaxo Wellcome UK Limited, trading
as Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Seretide Evohaler mite

25/50

Pressurised inhalation, suspension

Inhalation use

Seretide Evohaler

25/125

Pressurised inhalation, suspension

Inhalation use

Seretide Evohaler forte

25/250

Pressurised inhalation, suspension

Inhalation use

Seretide 25/50

25/50

Pressurised inhalation, suspension

Inhalation use

Seretide 25/125

25/125

Pressurised inhalation, suspension

Inhalation use

Seretide 25/250

25/250

Pressurised inhalation, suspension

Inhalation use

Seretide 50 Evohaler

25/50

Pressurised inhalation, suspension

Inhalation use

Seretide 125 Evohaler

25/125

Pressurised inhalation, suspension

Inhalation use

Seretide 250 Evohaler

50/250

Pressurised inhalation, suspension

Inhalation use

.

.

8
9
2
0
0
6

E
N

O

f
f
i
c
i
a
l

J
o
u
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n
a
l

o
f

t
h
e

E
u
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a
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U
n
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i

C
2
1
7
/
3
5