Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 June 2003 to 15 July 2003 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2003-07-25
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation, public health

25.7.2003

EN

Official Journal of the European Union

C 176/7

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 June 2003 to 15 July 2003

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

— Issuing, maintenance or modification of a national marketing authorisation

(2003/C 176/03)

Date of
the decision

Name(s) of the
medicinal product

Holder(s) of the marketing
authorization

Member State concerned

Date of
notification

25.6.2003

Botox

See Annex I

See Annex I

30.6.2003

26.6.2003

Somatropin

See Annex II

See Annex II

27.6.2003

26.6.2003

Somatropin

See Annex III

See Annex III

27.6.2003

30.6.2003

Calcium folinate

See Annex IV

See Annex IV

2.7.2003

— Lift of suspension of a marketing authorization

Date of the
decision

Name(s) of the
medicinal product

Holder(s) of the marketing
authorization

Member State concerned

Date of
notification

14.7.2003

Felodipine

See Annex V

See Annex V

16.7.2003

14.7.2003

Felodipine

See Annex VI

See Annex VI

16.7.2003

14.7.2003

Felodipine

See Annex VII

See Annex VII

16.7.2003

14.7.2003

Felodipine

See Annex VIII

See Annex VIII

16.7.2003

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

ANNEX I

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF
ADMINISTRATION, APPLICANT MARKETING AUTHORISATION HOLDER, PACKAGING AND PACKAGE
SIZE IN THE MEMBER STATES

Member State

Marketing Authorisation
Holder

Applicant

Invented name

Strength

Pharmaceutical Form Route of administration

Packaging

Package-size

AUSTRIA

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

BELGIUM

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

DENMARK

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

FINLAND

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

GREECE

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

GERMANY

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

IRELAND

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

ITALY

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

C

1
7
6
/
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
5
7
2
0
0
3

Member State

Marketing Authorisation
Holder

Applicant

Invented name

Strength

Pharmaceutical Form Route of administration

Packaging

Package-size

LUXEMBOURG

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

PORTUGAL

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

SPAIN

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

SWEDEN

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

ICELAND

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

NORWAY

Allergan Pharmaceuticals
Ireland

Allergan Pharmaceuticals
Ireland

Botox

100 units

Powder for Solution
for Injection

Intradermal use

Vial (glass)

1 vial

.

.

2
5
7
2
0
0
3

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

1
7
6
/
9

C 176/10

EN

Official Journal of the European Union

25.7.2003

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

ANNEX II

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

AUSTRIA

Pharmacia Austria GmbH
A-1100 Wien

Pharmacia Austria GmbH
A-1100 Wien

Pharmacia Austria GmbH
A-1100 Wien

Pharmacia Austria GmbH
A-1100 Wien

Pharmacia Austria GmbH
A-1100 Wien

Pharmacia Austria GmbH
A-1100 Wien

Pharmacia Austria GmbH
A-1100 Wien

Pharmacia Austria GmbH
A-1100 Wien

Pharmacia Austria GmbH
A-1100 Wien

5,3 mg/ml

12 mg/ml

0,2 mg

0,4 mg

0,6 mg

0,8 mg

1,0 mg

1,2 mg

1,4 mg

Genotropin
5,3 mg/ml
KabiPen —
Zylinder-
ampullen

Genotropin
12 mg/ml
KabiPen —
Zylinder-
ampullen

Genotropin
0,2 mg
MiniQuick
— Spritz-
ampullen

Genotropin
0,4 mg
MiniQuick
— Spritz-
ampullen

Genotropin
0,6 mg
MiniQuick
— Spritz-
ampullen

Genotropin
0,8 mg
MiniQuick
— Spritz-
ampullen

Genotropin
1 mg
MiniQuick
— Spritz-
ampullen

Genotropin
1,2 mg
MiniQuick
— Spritz-
ampullen

Genotropin
1,4 mg
MiniQuick
— Spritz-
ampullen

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

5

5

7

7

7

7

7

7

7

25.7.2003

EN

Official Journal of the European Union

C 176/11

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

AUSTRIA
(cont’d)

Pharmacia Austria GmbH
A-1100 Wien

Pharmacia Austria GmbH
A-1100 Wien

Pharmacia Austria GmbH
A-1100 Wien

BELGIUM/
LUXEM-
BOURG

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

PHARMACIA NV/SA
Rijksweg 12
2870 Puurs
Nederland

1,6 mg

1,8 mg

2,0 mg

1,3 mg

5,0 mg

5,3 mg

12 mg

1,3 mg

5,0 mg

5,3 mg

12 mg

Genotropin
1,6 mg
MiniQuick
— Spritz-
ampullen

Genotropin
1,8 mg
MiniQuick
— Spritz-
ampullen

Genotropin
2 mg
MiniQuick
— Spritz-
ampullen

Genoto-
norm
1,3 mg

Genoto-
norm
5,0 mg

Genoto-
norm
5,3 mg

Genoto-
norm
12 mg

Genoto-
norm
1,3 mg
KabiVial

Genoto-
norm
5,0 mg
KabiVial

Genoto-
norm
5,3 mg
KabiVial

Genoto-
norm
12 mg
KabiVial

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

7

7

7

Subcutaneous
use

Vial + ampoule

1

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

1, 5
5

1, 5
5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge
(single dose
container)

1, 5

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

1

1

1

C 176/12

EN

Official Journal of the European Union

25.7.2003

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

BELGIUM/
LUXEM-
BOURG
(cont’d)

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

Pharmacia NV/SA
Rijksweg 12
2870 Puurs
Nederland

0,2 mg

0,4 mg

0,6 mg

0,8 mg

1,0 mg

1,2 mg

1,4 mg

1,6 mg

1,8 mg

2,0 mg

Genoto-
norm
Miniquick
0,2 mg

Genoto-
norm
Miniquick
0,4 mg

Genoto-
norm
Miniquick
0,6 mg

Genoto-
norm
Miniquick
0,8 mg

Genoto-
norm
Miniquick
1,0 mg

Genoto-
norm
Miniquick
1,2 mg

Genoto-
norm
Miniquick
1,4 mg

Genoto-
norm
Miniquick
1,6 mg

Genoto-
norm
Miniquick
1,8 mg

Genoto-
norm
Miniquick
2,0 mg

DENMARK

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
1,3 mg

1,3 mg/ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
0,7 mg
KabiQuick

0,7 mg/
0,5 ml

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Vial + ampoule

7

7

7

7

7

7

7

7

7

7

1

Subcutaneous
use

Cartridge
(single dose
container)

10

25.7.2003

EN

Official Journal of the European Union

C 176/13

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

DENMARK
(cont’d)

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
1 mg
KabiQuick

1 mg/
0,75 ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
1,3 mg
KabiQuick

1,3 mg/ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
1,3 mg
KabiVial

1,3 mg/ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
1,3 mg

1,3 mg/ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
5,0 mg
KabiVial

5,0 mg/ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
5,0 mg

5,0 mg/ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
5,3 mg
KabiVial

5,3 mg/ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
5,3 mg

5,3 mg/ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
12 mg
KabiVial

12 mg/ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
12 mg

12 mg/ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
MiniQuick
0,2 mg

0,2 mg/
0,25 ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
MiniQuick
0,4 mg

0,4 mg/
0,25 ml

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

10

10

1
5

1

1

1
5

1

1
5

1

1
5

7

7

C 176/14

EN

Official Journal of the European Union

25.7.2003

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

DENMARK
(cont’d)

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
MiniQuick
0,6 mg

0,6 mg/
0,25 ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
MiniQuick
0,8 mg

0,8 mg/
0,25 ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
MiniQuick
1,0 mg

1,0 mg/
0,25 ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
MiniQuick
1,2 mg

1,2 mg/
0,25 ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
MiniQuick
1,4 mg

1,4 mg/
0,25 ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
MiniQuick
1,6 mg

1,6 mg/
0,25 ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
MiniQuick
1,8 mg

1,8 mg/
0,25 ml

Pharmacia AS
Overgaden neden Vandet 7
DK-1414 Copenhagen K

Genotropin
MiniQuick
2,0 mg

2,0 mg/
0,25 ml

FINLAND

Pharmacia Oy
Rajatorpantie 41 C
FIN-01640 Vantaa

Genotropin
5 mg

5 mg

Pharmacia Oy
Rajatorpantie 41 C
FIN-01640 Vantaa

Genotropin
12 mg

12 mg

FRANCE

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

1,3 mg/
1 ml

Genoto-
norm
1,3 mg/
1 ml
without
preservative
for
Kabidevice

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection in
cartridge

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge
(single dose
container)

7

7

7

4
7

4
7

4
7

4
7

4
7

1
5

1
5

1
5

25.7.2003

EN

Official Journal of the European Union

C 176/15

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

FRANCE
(cont’d)

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

5 mg/
1 ml

Genoto-
norm
5 mg/
1 ml with
preservative

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

5,3 mg/
1 ml

12 mg/
1 ml

1,3 mg/
1 ml

5 mg/
1 ml

5,3 mg/
1 ml

12 mg/
1 ml

0,7 mg/
0,5 ml

1 mg/
0,75 ml

Genoto-
norm
5,3 mg/
1 ml with
preservative

Genoto-
norm
12 mg/
1 ml with
preservative

Genoto-
norm
Kabivial
1,3 mg/
1 ml
without
preservative

Genoto-
norm
Kabivial
5 mg/
1 ml with
preservative

Genoto-
norm
Kabivial
5,3 mg/
1 ml with
preservative

Genoto-
norm
Kabivial
12 mg/
1 ml with
preservative

Genoto-
norm
Kabiquick
0,7 mg/
0,5 ml

Genoto-
norm
Kabiquick
1 mg/
0,75 ml

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Powder and
solvent for
solution for
injection in
cartridge

Powder and
solvent for
solution for
injection in
cartridge

Powder and
solvent for
solution for
injection in
cartridge

Powder and
solvent for
solution for
injection in
cartridge

Powder and
solvent for
solution for
injection in
cartridge

Powder and
solvent for
solution for
injection in
cartridge

Powder and
solvent for
solution for
injection in
cartridge

Powder and
solvent for
solution for
injection in a
prefilled syringe

Powder and
solvent for
solution for
injection in a
prefilled syringe

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

1
5

1
5

1
5

1
5

1
5

1
5

1
5

10

10

C 176/16

EN

Official Journal of the European Union

25.7.2003

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

FRANCE
(cont’d)

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

1,3 mg/
1 ml

0,2 mg/
0,25 ml

0,4 mg/
0,25 ml

0,6 mg/
0,25 ml

0,8 mg/
0,25 ml

1 mg/
0,25 ml

1,2 mg/
0,25 ml

1,4 mg/
0,25 ml

1,6 mg/
0,25 ml

Genoto-
norm
Kabiquick
1,3 mg/
1 ml

Genoto-
norm
Miniquick
0,2 mg/
0,25 ml

Genoto-
norm
Miniquick
0,4 mg/
0,25 ml

Genoto-
norm
Miniquick
0,6 mg/
0,25 ml

Genoto-
norm
Miniquick
0,8 mg/
0,25 ml

Genoto-
norm
Miniquick
1 mg/
0,25 ml

Genoto-
norm
Miniquick
1,2 mg/
0,25 ml

Genoto-
norm
Miniquick
1,4 mg/
0,25 ml

Genoto-
norm
Miniquick
1,6 mg/
0,25 ml

Powder and
solvent for
solution for
injection in a
prefilled syringe

Powder and
solvent for
solution for
injection in a
prefilled syringe

Powder and
solvent for
solution for
injection in a
prefilled syringe

Powder and
solvent for
solution for
injection in a
prefilled syringe

Powder and
solvent for
solution for
injection in a
prefilled syringe

Powder and
solvent for
solution for
injection in a
prefilled syringe

Powder and
solvent for
solution for
injection in a
prefilled syringe

Powder and
solvent for
solution for
injection in a
prefilled syringe

Powder and
solvent for
solution for
injection in a
prefilled syringe

Subcutaneous
use

Cartridge
(single dose
container)

10

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

7

7

7

7

7

7

7

7

25.7.2003

EN

Official Journal of the European Union

C 176/17

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

FRANCE
(cont’d)

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

Pharmacia SAS
1, rue Antoine Lavoisier
F-78280 Guyancourt

1,8 mg/
0,25 ml

2 mg/
0,25 ml

Genoto-
norm
Miniquick
1,8 mg/
0,25 ml

Genoto-
norm
Miniquick
2 mg/
0,25 ml

GERMANY

Pharmacia GmbH
D-91051 Erlangen

Genotropin
1,3 mg

1,3 mg/
ml

Powder and
solvent for
solution for
injection in a
prefilled syringe

Powder and
solvent for
solution for
injection in a
prefilled syringe

Powder and
solvent for
solution for
injection

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

7

7

Subcutaneous
use

Cartridge (single
dose container) or
Vial + ampoule

1, 5
1, 10

Pharmacia GmbH
D-91051 Erlangen

1,3 mg/
ml

Genotropin
4 I.E.
(1,3 mg)
Multidose

Powder and
solvent for
solution for
injection

Subcutaneous
use

Cartridge

1
5

Pharmacia GmbH
D-91051 Erlangen

Genotropin
5 mg/ml

5 mg/
ml

Pharmacia GmbH
D-91051 Erlangen

Genotropin
5,3 mg

5,3 mg/
ml

Pharmacia GmbH
D-91051 Erlangen

Genotropin
12 mg

12 mg/
ml

Pharmacia GmbH
D-91051 Erlangen

Genotropin
MiniQuick
0,2 mg

0,2 mg/
0,25 ml

Pharmacia GmbH
D-91051 Erlangen

Genotropin
MiniQuick
0,4 mg

0,4 mg/
0,25 ml

Pharmacia GmbH
D-91051 Erlangen

Genotropin
MiniQuick
0,6 mg

0,6 mg/
0,25 ml

Pharmacia GmbH
D-91051 Erlangen

Genotropin
MiniQuick
0,8 mg

0,8 mg/
0,25 ml

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Cartridge

1, 5, 4×5

Subcutaneous
use

Cartridge

1, 5, 4×5

Subcutaneous
use

Cartridge

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

1
5

7
4×7

7
4×7

7
4×7

7
4×7

C 176/18

EN

Official Journal of the European Union

25.7.2003

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

GERMANY
(cont’d)

Pharmacia GmbH
D-91051 Erlangen

Genotropin
MiniQuick
1,0 mg

1,0 mg/
0,25 ml

GREECE

Pharmacia GmbH
D-91051 Erlangen

Genotropin
MiniQuick
1,2 mg

1,2 mg/
0,25 ml

Pharmacia GmbH
D-91051 Erlangen

Genotropin
MiniQuick
1,4 mg

1,4 mg/
0,25 ml

Pharmacia GmbH
D-91051 Erlangen

Genotropin
MiniQuick
1,6 mg

1,6 mg/
0,25 ml

Pharmacia GmbH
D-91051 Erlangen

Genotropin
MiniQuick
1,8 mg

1,8 mg/
0,25 ml

Pharmacia GmbH
D-91051 Erlangen

Genotropin
MiniQuick
2,0 mg

2,0 mg/
0,25 ml

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Genotropin

5,0 mg

Genotropin

5,3 mg

Genotropin

12 mg

Genotropin

1,3 mg

Genotropin

1,3 mg

Genotropin

0,2 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

7
4×7

7
4×7

7
4×7

7
4×7

7
4×7

7
4×7

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

10

1, 5

Subcutaneous
use

Injection syringe
(single dose
container)

1

25.7.2003

EN

Official Journal of the European Union

C 176/19

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

GREECE
(cont’d)

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Genotropin

0,4 mg

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Pharmacia Hellas S.A,
2 Kalavryton str.,
N. Kiffissia 14564,
GR-Athens

Genotropin

0,6 mg

Genotropin

0,8 mg

Genotropin

1 mg

Genotropin

1,2 mg

Genotropin

1,4 mg

Genotropin

1,6 mg

Genotropin

1,8 mg

Genotropin

2 mg

IRELAND

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

0,2 mg

Genotropin
MiniQuick
0,2 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

0,4 mg

Genotropin
MiniQuick
0,4 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

0,6 mg

Genotropin
MiniQuick
0,6 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

1

1

1

1

1

1

1

1

1

7

7

7

C 176/20

EN

Official Journal of the European Union

25.7.2003

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

IRELAND
(cont’d)

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

0,8 mg

Genotropin
MiniQuick
0,8 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1 mg

Genotropin
MiniQuick
1 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1,2 mg

Genotropin
MiniQuick
1,2 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1,4 mg

Genotropin
MiniQuick
1,4 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1,6 mg

Genotropin
MiniQuick
1,6 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1,8 mg

Genotropin
MiniQuick
1,8 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

2,0 mg

Genotropin
MiniQuick
2,0 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

0,7 mg

Genotropin
0,7 mg
Kabiquick

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1 mg

Genotropin
1 mg
Kabiquick

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1,3 mg

Genotropin
1,3 mg
Kabiquick

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

Genotropin
1,3 mg

1,3 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

Genotropin
12 mg

12 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

7

7

4, 7

4, 7

4, 7

4, 7

4, 7

10

10

10

1

Subcutaneous
use

Cartridge

1, 5

25.7.2003

EN

Official Journal of the European Union

C 176/21

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

IRELAND
(cont’d)

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

5 mg

Genotropin
5 mg
Injection

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

5 mg

Genotropin
5 mg
Kabivial

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

Genotropin
5,3 mg

5,3 mg

ITALY

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

0,7 mg

Genotropin
0,7 mg
Kabiquick

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

1 mg

Genotropin
1 mg
Kabiquick

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

1,3 mg

Genotropin
1,3 mg
Kabiquick

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

1,3 mg

Genotropin
1,3 mg
KabiVial

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

5,3 mg

Genotropin
5,3 mg
KabiVial

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

12 mg

Genotropin
12 mg
KabiVial

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

5,3 mg

12 mg

Genotropin
5,3 mg
for
Genotropin-
Pen

Genotropin
12 mg for
Genotropin-
Mixer,
Genotropin-
Pen

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge
(single dose
container)

10

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge

8

6

1

1

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1

Subcutaneous
use

Cartridge

1, 5

C 176/22

EN

Official Journal of the European Union

25.7.2003

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

ITALY
(cont’d)

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

0,2 mg

Genotropin
MiniQuick
0,2 mg

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

0,4 mg

Genotropin
MiniQuick
0,4 mg

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

0,6 mg

Genotropin
MiniQuick
0,6 mg

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

0,8 mg

Genotropin
MiniQuick
0,8 mg

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

1,0 mg

Genotropin
MiniQuick
1 mg

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

1,2 mg

Genotropin
MiniQuick
1,2 mg

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

1,4 mg

Genotropin
MiniQuick
1,4 mg

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

1,6 mg

Genotropin
MiniQuick
1,6 mg

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

1,8 mg

Genotropin
MiniQuick
1,8 mg

Pharmacia AB
Lindhagensgatan 133
SE-11287 Stockholm

2,0 mg

Genotropin
MiniQuick
2 mg

THE
NETHER-
LANDS

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

0,7 mg

Genotropin
0,7 mg
KabiQuick

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

1 mg

Genotropin
1 mg
KabiQuick

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

7

7

7

7

7

4

4

4

4

4

10

10

25.7.2003

EN

Official Journal of the European Union

C 176/23

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

THE
NETHER-
LANDS
(cont’d)

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

1,3 mg

Genotropin
1,3 mg
KabiQuick

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

1,3 mg

Genotropin
1,3 mg
KabiVial

Genotropin
1,3 mg

1,3 mg

5,0 mg

Genotropin
5,0 mg
KabiVial

Genotropin
5,0 mg

5,0 mg

5,3 mg

Genotropin
5,3 mg
KabiVial

Genotropin
5,3 mg

5,3 mg

Genotropin
12 mg

12 mg

0,2 mg

Genotropin
MiniQuick
0,2 mg

0,4 mg

Genotropin
MiniQuick
0,4 mg

0,6 mg

Genotropin
MiniQuick
0,6 mg

0,8 mg

Genotropin
MiniQuick
0,8 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Route of
administration

Packaging

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Package
size

10

1, 5

1

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

7

7

7

7

C 176/24

EN

Official Journal of the European Union

25.7.2003

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

THE
NETHER-
LANDS
(cont’d)

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

1 mg

Genotropin
MiniQuick
1 mg

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

1,2 mg

Genotropin
MiniQuick
1,2 mg

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

1,4 mg

Genotropin
MiniQuick
1,4 mg

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

1,6 mg

Genotropin
MiniQuick
1,6 mg

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

1,8 mg

Genotropin
MiniQuick
1,8 mg

Pharmacia BV
Houttuinlaan 4
3447 GM Woerden
Nederland

2 mg

Genotropin
MiniQuick
2 mg

PORTUGAL

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin

1,3 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin

1,3 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin

5,0 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin

5,3 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Injection syringe
(single dose
container)

7

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

4, 7

4, 7

4, 7

4, 7

4, 7

Subcutaneous
use

Vial + ampoule

1

Subcutaneous
use

Cartridge
(single dose
container)

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1, 5

25.7.2003

EN

Official Journal of the European Union

C 176/25

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

PORTUGAL
(cont’d)

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin

12 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Kabi Vial

5,0 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Kabi Vial

5,3 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
KabiQuick

0,7 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
KabiQuick

1 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
KabiQuick

1,3 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Miniquick

0,2 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Miniquick

0,4 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Miniquick

0,6 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Miniquick

0,8 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Miniquick

1,0 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Miniquick

1,2 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

10

10

10

1

1

1

1

1

1

C 176/26

EN

Official Journal of the European Union

25.7.2003

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

PORTUGAL
(cont’d)

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Miniquick

1,4 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Miniquick

1,6 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Miniquick

1,8 mg

Pharmacia Corporation
Laboratórios, Lda
Avenida do Forte, 3-Edifício
P-2795-505 Carnaxide

Genotropin
Miniquick

2,0 mg

SPAIN

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

0,7 mg

Genoto-
norm
0,7 mg
Kabiquick

1 mg

Genoto-
norm 1 mg
Kabiquick

1,3 mg

Genoto-
norm
1,3 mg
Kabiquick

1,3 mg

Genoto-
norm 1,3
Kabi vial s.c.

1,3 mg

Genoto-
norm
1,3 mg
Kabivial c.c.

5,3 mg

5,3 mg

12 mg

Genoto-
norm
5,3 mg
Kabivial

Genoto-
norm
5,3 mg
Kabipen

Genoto-
norm
12 mg
Kabivial

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

1

1

1

1

10

10

10

Subcutaneous
use

Cartridge
(single dose
container)

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

1

1

1

25.7.2003

EN

Official Journal of the European Union

C 176/27

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

SPAIN
(cont’d)

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

Pharmacia Spain, SA

12 mg

5,0 mg

5,0 mg

0,2 mg

0,4 mg

0,6 mg

0,8 mg

1 mg

1,2 mg

1,4 mg

1,6 mg

1,8 mg

Genoto-
norm
12 mg
Kabipen

Genoto-
norm
5,0 mg
Kabivial

Genoto-
norm
5,0 mg

Genoto-
norm
Miniquick
0,2 mg

Genoto-
norm
Miniquick
0,4 mg

Genoto-
norm
Miniquick
0,6 mg

Genoto-
norm
Miniquick
0,8 mg

Genoto-
norm
Miniquick
1 mg

Genoto-
norm
Miniquick
1,2 mg

Genoto-
norm
Miniquick
1,4 mg

Genoto-
norm
Miniquick
1,6 mg

Genoto-
norm
Miniquick
1,8 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Cartridge

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

1

1

1

7

7

7

7

7

7

7

7

7

C 176/28

EN

Official Journal of the European Union

25.7.2003

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

SPAIN
(cont’d)

Pharmacia Spain, SA

2 mg

Genoto-
norm
Miniquick
2 mg

SWEDEN

Pharmacia Sverige AB

Genotropin
Miniquick

0,2 mg

Pharmacia Sverige AB

Genotropin
Miniquick

0,4 mg

Pharmacia Sverige AB

Genotropin
Miniquick

0,6 mg

Pharmacia Sverige AB

Genotropin
Miniquick

0,8 mg

Pharmacia Sverige AB

Genotropin
Miniquick

1,0 mg

Pharmacia Sverige AB

Genotropin
Miniquick

1,2 mg

Pharmacia Sverige AB

Genotropin
Miniquick

1,4 mg

Pharmacia Sverige AB

Genotropin
Miniquick

1,6 mg

Pharmacia Sverige AB

Genotropin
Miniquick

1,8 mg

Pharmacia Sverige AB

Genotropin
Miniquick

2,0 mg

Pharmacia Sverige AB

Genotropin

12 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

7

7

7

7

7

7

7

7

7

7

7

Subcutaneous
use

Cartridge

1, 5

25.7.2003

EN

Official Journal of the European Union

C 176/29

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

SWEDEN
(cont’d)

Pharmacia Sverige AB

Genotropin

5,3 mg

Pharmacia Sverige AB

Genotropin

5,0 mg

Pharmacia Sverige AB

Genotropin

1,3 mg

Pharmacia Sverige AB

Genotropin
(KabiQuick)

0,7 mg

Pharmacia Sverige AB

Genotropin
(KabiQuick)

1 mg

Pharmacia Sverige AB

Genotropin
(KabiQuick)

1,3 mg

UNITED
KINGDOM

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

0,2 mg

Genotropin
MiniQuick
0,2 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

0,4 mg

Genotropin
MiniQuick
0,4 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

0,6 mg

Genotropin
MiniQuick
0,6 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

0,8 mg

Genotropin
MiniQuick
0,8 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1,0 mg

Genotropin
MiniQuick
1,0 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1,2 mg

Genotropin
MiniQuick
1,2 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge (single
dose container) or
Vial + ampoule

1, 10

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Cartridge
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

10

10

10

7

7

7

7

7

7

C 176/30

EN

Official Journal of the European Union

25.7.2003

Member State Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package
size

UNITED
KINGDOM
(cont’d)

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1,4 mg

Genotropin
MiniQuick
1,4 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1,6 mg

Genotropin
MiniQuick
1,6 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

1,8 mg

Genotropin
MiniQuick
1,8 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

2,0 mg

Genotropin
MiniQuick
2,0 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

Genotropin
12 mg

12 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

Genotropin
12 mg
KabiVial
Multidose

12 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

5 mg

Genotropin
5 mg
Injection

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

5 mg

Genotropin
5 mg
KabiVial

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

Genotropin
1,3 mg

1,3 mg

Genotropin
5,3 mg

5,3 mg

Pharmacia Laboratories Ltd
Davy Avenue
Milton Keynes MK5 8PH
United Kingdom

Genotropin
5,3 mg
KabiVial
Multidose

5,3 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

Subcutaneous
use

Injection syringe
(single dose
container)

7

7

7

7

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Vial + ampoule

1

Subcutaneous
use

Cartridge

1, 5

Subcutaneous
use

Cartridge

1

25.7.2003

EN

Official Journal of the European Union

C 176/31

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN
THE MEMBER STATES

NORDITROPIN CONTAINING MEDICINAL PRODUCTS WITH MARKETING AUTHORISATION IN THE EUROPEAN
UNION

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of
Administration

Packaging

Package-size

AUSTRIA

Novo Nordisk Pharma
Gesellschaft mbH
Erdbergstraße 52-60/3/16
A-1030 Wien

Novo Nordisk Pharma
Gesellschaft mbH
Erdbergstraße 52-60/3/16
A-1030 Wien

Novo Nordisk Pharma
Gesellschaft mbH
Erdbergstraße 52-60/3/16
A-1030 Wien

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

BELGIUM

Novo Nordisk Pharma SA
Boulevard International, 55
B-1070 Brussels

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

DENMARK

Novo Nordisk Pharma SA
Boulevard International, 55
B-1070 Brussels

Novo Nordisk Pharma SA
Boulevard International, 55
B-1070 Brussels

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin

1,3 mg

Norditropin

4 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous

Vial

1 and 10

Subcutaneous

Vial

1

C 176/32

EN

Official Journal of the European Union

25.7.2003

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of
Administration

Packaging

Package-size

DENMARK
(cont’d)

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
PenSet

4 mg

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
PenSet

8 mg

Subcutaneous

Vial

1 and 6

Subcutaneous

Vial

1 and 6

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

FINLAND

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3, and 5

FRANCE

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk France
Pharmaceutique SA
Le Palatin
30, rue de Valmy
La Défense 12
F-92936 Paris la Défenseé

Novo Nordisk France
Pharmaceutique SA
Le Palatin
30, rue de Valmy
La Défense 12
F-92936 Paris la Défenseé

Novo Nordisk France
Pharmaceutique SA
Le Palatin
30, rue de Valmy
La Défense 12
F-92936 Paris la Défenseé

Novo Nordisk France
Pharmaceutique SA
Le Palatin
30, rue de Valmy
La Défense 12
F-92936 Paris la Défenseé

Novo Nordisk France
Pharmaceutique SA
Le Palatin
30, rue de Valmy
La Défense 12
F-92936 Paris la Défenseé

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3, and 5

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3, and 5

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3, and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3, and 5

Norditropin

1,3 mg

Norditropin

4 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous

Cartridge

1 and 10

Subcutaneous

Vial

1

25.7.2003

EN

Official Journal of the European Union

C 176/33

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of
Administration

Packaging

Package-size

FRANCE
(cont’d)

GERMANY

Novo Nordisk France
Pharmaceutique SA
Le Palatin
30, rue de Valmy
La Défense 12
F-92936 Paris la Défenseé

Novo Nordisk France
Pharmaceutique SA
Le Palatin
30, rue de Valmy
La Défense 12
F-92936 Paris la Défenseé

Novo Nordisk Pharma
GmbH
Brücknerstraße 1
D-55127 Mainz

Novo Nordisk Pharma
GmbH
Brücknerstraße 1
D-55127 Mainz

Novo Nordisk Pharma
GmbH
Brücknerstraße 1
D-55127 Mainz

Norditropin
PenSet

4 mg

Norditropin
PenSet

8 mg

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Subcutaneous

Vial

1 and 6

Subcutaneous

Vial

1 and 6

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3, and 5

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3, and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

GREECE

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin

1,3 mg

Norditropin

4 mg

Subcutaneous

Vial

1 and 10

Subcutaneous

Vial

1

Subcutaneous

Vial

1 and 6

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
PenSet

4 mg

C 176/34

EN

Official Journal of the European Union

25.7.2003

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of
Administration

Packaging

Package-size

GREECE
(cont’d)

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
PenSet

8 mg

Powder and
solvent for
solution for
injection

Subcutaneous

Vial

1 and 6

IRELAND

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin

1,3 mg

Norditropin

4 mg

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
PenSet

4 mg

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
PenSet

8 mg

Subcutaneous

Vial

1 and 10

Subcutaneous

Vial

1

Subcutaneous

Vial

1 and 6

Subcutaneous

Vial

1 and 6

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

ITALY

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin

1,3 mg

Powder and
solvent for
solution for
injection

Subcutaneous

Vial

1 and 10

25.7.2003

EN

Official Journal of the European Union

C 176/35

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of
Administration

Packaging

Package-size

ITALY
(cont’d)

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin

4 mg

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
PenSet

4 mg

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
PenSet

8 mg

Subcutaneous

Vial

1

Subcutaneous

Vial

1 and 6

Subcutaneous

Vial

1 and 6

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

Powder and
solvent for
solution for
injection

LUXEMBOURG

Novo Nordisk Pharma SA
Boulevard International, 55
B-1070 Brussels

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Novo Nordisk Pharma SA
Boulevard International, 55
B-1070 Brussels

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Novo Nordisk Pharma SA
Boulevard International, 55
B-1070 Brussels

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

NETHERLANDS Novo Nordisk Farma

Flemingweg 18
2408 AV Alphen a/d Rijn
Nederland

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Novo Nordisk Farma
Flemingweg 18
2408 AV Alphen a/d Rijn
Nederland

Novo Nordisk Farma
Flemingweg 18
2408 AV Alphen a/d Rijn
Nederland

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

PORTUGAL

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

C 176/36

EN

Official Journal of the European Union

25.7.2003

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of
Administration

Packaging

Package-size

SPAIN

SWEDEN

UNITED
KINGDOM

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk Ltd
Broadfield Park
Brighton Road
West Sussex RH11 9RT
United Kingdom

Novo Nordisk Ltd
Broadfield Park
Brighton Road
West Sussex RH11 9RT
United Kingdom

Novo Nordisk Ltd
Broadfield Park
Brighton Road
West Sussex RH11 9RT
United Kingdom

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

5 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

10 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

Norditropin
SimpleXx

15 mg/1,5 ml

Solution for
injection

Subcutaneous

Cartridge

1, 3 and 5

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES
OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN
THE MEMBER STATES

ANNEX IV

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

Packaging

Content/concen-
tration

Package-size

AUSTRIA

Wyeth Lederle Pharma GmbH
Storchengasse 1
A-1150 Wien

Leucovorin

3 mg/1 ml

Wyeth Lederle Pharma GmbH
Storchengasse 1
A-1150 Wien

Wyeth Lederle Pharma GmbH
Storchengasse 1
A-1150 Wien

Wyeth Lederle Pharma GmbH
Storchengasse 1
A-1150 Wien

Wyeth Lederle Pharma GmbH
Storchengasse 1
A-1150 Wien

Wyeth Lederle Pharma GmbH
Storchengasse 1
A-1150 Wien

Wyeth Lederle Pharma GmbH
Storchengasse 1
A-1150 Wien

AHP Pharma SA
Rue du Bosquet, 15
B-1348 Louvain la Neuve

AHP Pharma SA
Rue du Bosquet, 15
B-1348 Louvain la Neuve

BELGIUM

Leucovorin

10 mg/1 ml

Leucovorin

30 mg/3 ml

Leucovorin

50 mg/5 ml

Leucovorin

100 mg/10 ml

Leucovorin

200 mg/20 ml

Leucovorin

300 mg/30 ml

Solution for
injection

Solution for
injection

Solution for
injection

Solution for
injection

Solution for
injection

Solution for
injection

Solution for
injection

IV or IM

Ampoule

3 mg/ml

10

IV or IM

Ampoule

10 mg/ml

1

IV or IM

Ampoule

10 mg/ml

1

IV or IM

Ampoule

10 mg/ml

1, 25

IV or IM

Ampoule

10 mg/ml

1, 25

IV or IM

Ampoule

10 mg/ml

1, 25

IV or IM

Ampoule

10 mg/ml

1, 25

Ledervorin
Calcium

3 mg/1 ml

Solution for
injection

IV or IM

Ampoule

3 mg/ml

6

Ledervorin
Calcium

50 mg/5 ml

Solution for
injection

IV or IM

Ampoule

10 mg/ml

1, 10

.

.

2
5
7
2
0
0
3

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

1
7
6
/
3
7

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

Packaging

BELGIUM
(cont’d)

AHP Pharma SA
Rue du Bosquet, 15
B-1348 Louvain la Neuve

Ledervorin
Calcium

100 mg/10 ml

Solution for
injection

IV or IM

AHP Pharma SA
Rue du Bosquet, 15
B-1348 Louvain la Neuve

AHP Pharma SA
Rue du Bosquet, 15
B-1348 Louvain la Neuve

Ledervorin
Calcium

300 mg/30 ml

Solution for
injection

IV or IM

Ledervorin
Calcium

500 mg/50 ml

Solution for
injection

IV or IM

GERMANY

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Leucovorin

30 mg

Powder for solution
for injection

IV or IM

Vial

Vial

Vial

Vial

Content/concen-
tration

Package-size

10 mg/ml

1, 10

10 mg/ml

1

10 mg/ml

1

30 mg

1, 5, 10

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Leucovorin

3 mg/1 ml

Solution for
injection

IV, IM

Ampoule

3 mg/ml

1, 5, 10, 50, 100

Calcium-
folinat

10 mg/1 ml

Solution for
injection

IV, IM

Ampoule

10 mg/ml

1, 2, 3, 5, 10

Calcium-
folinat

100 mg/10 ml

Solution for
injection

IV, IM

Ampoule

10 mg/ml

1, 2, 3, 5, 10

Calcium-
folinat

300 mg/30 ml

Solution for
injection

IV, IM

Ampoule

10 mg/ml

1

Calcium-
folinat

300 mg/30 ml

Solution for
injection

IV, IM

Calcium-
folinat

500 mg/50 ml

Solution for
injection

IV, IM

Vial

Vial

10 mg/ml

1, 2, 3, 5, 10

10 mg/ml

1, 2, 3, 5, 10

C

1
7
6
/
3
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
5
7
2
0
0
3

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

Packaging

GERMANY
(cont’d)

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Calcium-
folinat

900 mg/90 ml

Solution for
injection

IV, IM

Calcium-
folinat

1 000 mg/
100 ml

Solution for
injection

IV, IM

Content/concen-
tration

Package-size

10 mg/ml

1, 3, 5, 10

10 mg/ml

1, 2, 3, 5, 10

Vial

Vial

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Leucovorin

30 mg/3 ml

Leucovorin

50 mg/5 ml

Leucovorin

100 mg/10 ml

Leucovorin

100 mg/10 ml

Leucovorin

200 mg/20 ml

Leucovorin

200 mg/20 ml

Leucovorin

300 mg/30 ml

Leucovorin

300 mg/30 ml

Solution for
injection

Solution for
injection

Solution for
injection

Solution for
injection

Solution for
injection

Solution for
injection

Solution for
injection

Solution for
injection

IV, IM

Ampoule

10 mg/ml

1, 2, 3, 5, 10

IV, IM

Ampoule

10 mg/ml

1, 2, 3, 5, 10

IV, IM

Ampoule

10 mg/ml

1, 5, 10

IV, IM

Vial

10 mg/ml

1, 5, 10

IV, IM

Ampoule

10 mg/ml

1, 2, 3, 5, 10

IV, IM

Vial

10 mg/ml

1, 2, 3, 5, 10

IV, IM

Ampoule

10 mg/ml

1, 2, 3, 5, 10

IV, IM

Vial

10 mg/ml

1, 2, 3, 5, 10

.

.

2
5
7
2
0
0
3

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

1
7
6
/
3
9

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

Packaging

Content/concen-
tration

Package-size

GERMANY
(cont’d)

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Leucovorin

10 mg/1 ml

Leucovorin

20 mg/2 ml

Leucovorin

30 mg/3 ml

Leucovorin

50 mg/5 ml

Solution for
injection

Solution for
injection

Solution for
injection

Solution for
injection

IV, IM

Ampoule

10 mg/ml

1, 5 10

IV, IM

Ampoule

10 mg/ml

1, 5, 10

IV, IM

Ampoule

10 mg/ml

1, 5, 10

IV, IM

Ampoule

10 mg/ml

1, 5, 10

Leucovorin

100 mg/10 ml

Solution for
injection

IV, IM

Leucovorin

200 mg/20 ml

Solution for
injection

IV, IM

Leucovorin

250 mg/25 ml

Solution for
injection

IV, IM

Leucovorin

300 mg/30 ml

Solution for
injection

IV, IM

Leucovorin

500 mg/50 ml

Solution for
injection

IV, IM

Leucovorin

900 mg/90 ml

Solution for
injection

IV, IM

Vial

Vial

Vial

Vial

Vial

Vial

10 mg/ml

1, 5, 10

10 mg/ml

1, 5, 10

10 mg/ml

1, 5, 10

10 mg/ml

1, 5, 10

10 mg/ml

1, 5, 10

10 mg/ml

1, 5, 10

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

C

1
7
6
/
4
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

.

.

2
5
7
2
0
0
3

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

Packaging

Content/concen-
tration

Package-size

GERMANY
(cont’d)

Wyeth Pharma GmbH
Wienburgstraße 207
D-48159 Münster

Leucovorin

1 000 mg/
100 ml

Solution for
injection

IV, IM

Vial

10 mg/ml

1, 5, 10

GREECE

IRELAND

Wyeth Hellas SA
126 Kyprou 1
25th Martiou Str. 164
GR-16452 Athens

Wyeth Hellas SA
126 Kyprou 1
25th Martiou Str. 164
GR-16452 Athens

Wyeth Hellas SA
126 Kyprou 1
25th Martiou Str. 164
GR-16452 Athens

Cyanamid of Great Britain
Great Britain LTD
Fareham Road
Gosport
Hampshire PO13 0AS
United Kingdom

Cyanamid of Great Britain
Great Britain LTD
Fareham Road
Gosport
Hampshire PO13 0AS
United Kingdom

Cyanamid of Great Britain
Great Britain LTD
Fareham Road
Gosport
Hampshire PO13 0AS
United Kingdom

Leucovorin/
Lederle

100 mg/10 ml

Solution for
injection

IV, IM

Vial

10 mg/ml

1

Leucovorin/
Lederle

200 mg/20 ml

Solution for
injection

IV, IM

Vial

10 mg/ml

1

Leucovorin/
Lederle

30 mg

Powder for solution
for injection

IV, IM

Vial

30 mg

1

Lederfolin

350 mg/35 ml

Solution for
injection

IV, IM

Vial

10 mg/ml

1

Lederfolin

350 mg

Powder for solution
for injection

IV, IM

Vial

350 mg

1

Lederfolin

15 mg

Powder for solution
for injection

IV, IM

Vial

15 mg

1

.

.

2
5
7
2
0
0
3

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

1
7
6
/
4
1

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

Packaging

Content/concen-
tration

Package-size

IRELAND
(cont’d)

LUXEMBOURG

Cyanamid of Great Britain
Great Britain LTD
Fareham Road
Gosport
Hampshire PO13 0AS
United Kingdom

Cyanamid of Great Britain
Great Britain LTD
Fareham Road
Gosport
Hampshire PO13 0AS
United Kingdom

AHP Pharma SA
Rue du Bosquet 15,
B-1348 Louvain la Neuve
Belgium

AHP Pharma SA
Rue du Bosquet 15,
B-1348 Louvain la Neuve
Belgium

AHP Pharma SA
Rue du Bosquet 15,
B-1348 Louvain la Neuve
Belgium

AHP Pharma SA
Rue du Bosquet 15,
B-1348 Louvain la Neuve
Belgium

AHP Pharma SA
Rue du Bosquet 15,
B-1348 Louvain la Neuve
Belgium

Lederfolin

30 mg

Powder for solution
for injection

IV, IM

Vial

30 mg

1

Lederfolin

3 mg/1 ml

Solution for
injection

IV, IM

Ampoule

3 mg/ml

10

Ledervorin
Calcium

3 mg/1 ml

Solution for
injection

IV or IM

Ampoule

3 mg/ml

6

Ledervorin
Calcium

50 mg/5 ml

Solution for
injection

IV or IM

Ampoule

10 mg/ml

1, 10

Ledervorin
Calcium

100 mg/10 ml

Solution for
injection

IV or IM

Vial

10 mg/ml

1, 10

Ledervorin
Calcium

300 mg/30 ml

Solution for
injection

IV or IM

Vial

10 mg/ml

1

Ledervorin
Calcium

500 mg/50 ml

Solution for
injection

IV or IM

Vial

10 mg/ml

1

PORTUGAL

Teofarma srl
Head Office: via F.lli Cervi 8
I-27010 Valle Salimbene (PV)

Lederfoline

5 mg/2 ml

Solution for
injection

IV or IM

Ampoule

2.5 mg/ml

1

C

1
7
6
/
4
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

.

.

2
5
7
2
0
0
3

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

Packaging

Content/concen-
tration

Package-size

PORTUGAL
(cont’d)

Teofarma srl
Head Office: via F.lli Cervi 8
I-27010 Valle Salimbene (PV)

Lederfoline

50 mg/5 ml

Solution for
injection

IV or IM

Vial

10 mg/ml

1

Teofarma srl
Head Office: via F.lli Cervi 8
I-27010 Valle Salimbene (PV)

Lederfoline

100 mg/10 ml

Solution for
injection

IV or IM

Vial

10 mg/ml

1

Teofarma srl
Head Office: via F.lli Cervi 8
I-27010 Valle Salimbene (PV)

Lederfoline

200 mg/20 ml

Solution for
injection

IV or IM

Vial

10 mg/ml

1

Teofarma srl
Head Office: via F.lli Cervi 8
I-27010 Valle Salimbene (PV)

Lederfoline

300 mg/30 ml

Solution for
injection

IV or IM

Vial

10 mg/ml

1

Teofarma srl
Head Office: via F.lli Cervi 8
I-27010 Valle Salimbene (PV)

Lederfoline

350 mg/35 ml

Solution for
injection

IV or IM

Vial

10 mg/ml

1

Teofarma srl
Head Office: via F.lli Cervi 8
I-27010 Valle Salimbene (PV)

Lederfoline

500 mg/50 ml

Solution for
injection

IV or IM

Vial

10 mg/ml

1

SPAIN

Wyeth Farma SA
Ctra. Burgos, km 23
Devio Algete, km 1
E-28700 S. Sebastian de los
Reyes Madrid

Wyeth Farma SA
Ctra. Burgos, km 23
Devio Algete, km 1
E-28700 S. Sebastian de los
Reyes Madrid

Lederfolin

50 mg

Powder for solution
for injection

IV or IM

Powder: Vial Water
for injection:
Ampoule

1

Powder:
50 mg
Water for
injection:
5 ml

Lederfolin

350 mg

Powder for solution
for injection

IV

Vial

350 mg

1

.

.

2
5
7
2
0
0
3

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

1
7
6
/
4
3

Member State

Marketing Authorisation Holder

Name

Strength

Pharmaceutical Form

Route of administration

Packaging

Content/concen-
tration

Package-size

SPAIN
(cont’d)

UNITED
KINGDOM

Wyeth Farma SA
Ctra. Burgos, km 23
Devio Algete, km 1
E-28700 S. Sebastian de los
Reyes Madrid

Cyanamid of Great Britain LTD
Fareham Road
Gosport
Hampshire PO3 0AS
United Kingdom

Cyanamid of Great Britain LTD
Fareham Road
Gosport
Hampshire PO3 0AS
United Kingdom

Cyanamid of Great Britain LTD
Fareham Road
Gosport
Hampshire PO3 0AS
United Kingdom

Cyanamid of Great Britain LTD
Fareham Road
Gosport
Hampshire
PO3 0AS
United Kingdom

Cyanamid of Great Britain LTD
Fareham Road
Gosport
Hampshire
PO3 0AS
United Kingdom

Lederfolin

3 mg/1 ml

Solution for
injection

IM

Ampoule

3 mg/1 ml

6

Lederfolin

350 mg/35 ml

Solution for
injection

IV, IM

Vial

10 mg/ml

1

Lederfolin

350 mg

Powder for solution
for injection

IV, IM

Vial

350 mg

1

Calcium
Leucovorin

15 mg

Powder for solution
for injection

IV, IM

Vial

15 mg

1

Calcium
Leucovorin

30 mg

Powder for solution
for injection

IV, IM

Vial

30 mg

1

Calcium
Leucovorin

3 mg/1 ml

Solution for
injection

IV, IM

Ampoule

3 mg/ml

10

C

1
7
6
/
4
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

.

.

2
5
7
2
0
0
3

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, APPLICANTS, PACKAGING AND PACKAGE
SIZES IN THE MEMBER STATES

MR PROCEDURE DE/H/0355/001-003

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

Packaging

Package size

DENMARK

GERMANY

SPAIN

SWEDEN

Biochemie GmbH
Biochemiestraße 10
A-6250 Kundl

Biochemie GmbH
Biochemiestraße 10
A-6250 Kundl

Azupharma GmbH & Co.
Dieselstraße 5
D-70839 Gerlingen

Azupharma GmbH & Co.
Dieselstraße 5
D-70839 Gerlingen

Laboratorios Géminis SA
Gran Via de los Corts Catalanes
E-764 08013 Barcelona

Biochemie GmbH
Biochemiestraße 10
A-6250 Kundl

Biochemie GmbH
Biochemiestraße 10
A-6250 Kundl

Felodipin
Biochemie

Felodipin
Biochemie

5 mg

prolonged release tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 100, 100×1

10 mg

prolonged release tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 100, 100×1

Felodipin AZU

5 mg

prolonged release tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50 and 100
samples: 10

Felodipin AZU

10 mg

prolonged release tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50 and 100
samples: 10

Felodipino
Géminis

Felodipin
Biochemie

Felodipin
Biochemie

5 mg

prolonged release tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20

5 mg

prolonged release tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 100, 100×1

10 mg

prolonged release tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 100, 100×1

.

.

2
5
7
2
0
0
3

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

1
7
6
/
4
5

ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, APPLICANTS, PACKAGING AND PACKAGE
SIZES IN THE MEMBER STATES

MR PROCEDURE DE/H/0353/001-003

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Packaging

Package size

AUSTRIA

BELGIUM

DENMARK

GERMANY

UNITED
KINGDOM

Arcana Arzneimittel GmbH
Zimbagasse 5
A-1147 Wien

Merck nv/sa
Brusselsesteenweg 288
B-3090 Overijse

Merck nv/sa
Brusselsesteenweg 288
B-3090 Overijse

NM Pharma A/S
Overgaden neden Vandet 7
Dänemark

NM Pharma A/S
Overgaden neden Vandet 7
Dänemark

Merck dura GmbH
Frankfurter Straße 133
D-64293 Darmstadt

Merck dura GmbH
Frankfurter Straße 133
D-64293 Darmstadt

Generics UK Ltd,
Station Close,
Potters Bar
Hertfordshire EN6 1TL
United Kingdom

Generics UK Ltd,
Station Close,
Potters Bar
Hertfordshire EN6 1TL
United Kingdom

Felodipine Arcana

5 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

Merck-Felodipine

5 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

Merck-Felodipine

10 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodipin NM Pharma

5 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodipin NM Pharma

10 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28,
30, 50, 56, 60,
98, 100

10, 14, 20, 28,
30, 50, 56, 60,
98, 100

10, 14, 20, 28,
30, 50, 56, 60,
98, 100

10, 14, 20, 28,
30, 50, 56, 60,
98, 100

10, 14, 20, 28,
30, 50, 56, 60,
98, 100

Felodipin dura

5 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 10

Felodipin dura

10 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 10

Felogen XL

5 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felogen XL

10 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28,
30, 50, 56, 60,
98, 100

10, 14, 20, 28,
30, 50, 56, 60,
98, 100

C

1
7
6
/
4
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

.

.

2
5
7
2
0
0
3

ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, APPLICANTS, PACKAGING AND PACKAGE
SIZES IN THE MEMBER STATES

MR PROCEDURE DE/H/0352/001-003

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Packaging

Package size

AUSTRIA

ratiopharm Arzneimittel
Vertriebs-GmbH
Albert-Schweitzer-Gasse 3
A-1140 Wien

ratiopharm Arzneimittel
Vertriebs-GmbH
Albert-Schweitzer-Gasse 3
A-1140 Wien

Felodipin
‘ratiopharm’

5 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 30, 28, 50, 98,
100 and 250

Felodipin
‘ratiopharm’

10 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 30, 28, 50, 98,
100 and 250

BELGIUM

ratiopharm Belgien SA
141, Rue St.-Lambert
B-1200 Brussels

Felodipine-
ratiopharm

5 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

ratiopharm Belgien SA
141, Rue St.-Lambert
B-1200 Brussels

Felodipine-
ratiopharm

10 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 28, 30, 30×1,
50, 50×1, 98, 100,
100×1, 250

20, 28, 30, 30×1,
50, 50×1, 98, 100,
100×1, 250

DENMARK

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

Felodipin
ratiopharm

5 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

28, 30, 50, 98, 100,
250

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

Felodipin
ratiopharm

10 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

28, 30, 50, 98, 100,
250

.

.

2
5
7
2
0
0
3

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

1
7
6
/
4
7

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Packaging

Package size

GERMANY

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

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

LUXEMBOURG

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

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

Felodipin-
ratiopharm

5 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 20

Felodipin-
ratiopharm

10 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 20

Felodipin-
ratiopharm

5 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100

Felodipin
ratiopharm

10 mg

prolonged release
tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100

C

1
7
6
/
4
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
5
7
2
0
0
3

ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, APPLICANTS, PACKAGING AND PACKAGE
SIZES IN THE MEMBER STATES

MR PROCEDURE DE/H/0354/001-003

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form Route of administration

Packaging

Package size

AUSTRIA

BELGIUM

DENMARK

GERMANY

STADA Arzneimittel GesmbH
Heiligenstädter Straße 52/2/8
A-1190 Wien

STADA Arzneimittel GesmbH
Heiligenstädter Straße 52/2/8
A-1190 Wien

SA Eurogenerics NV
Heizel Esplanade Heysel b 22
B-1020 Brussel

SA Eurogenerics NV
Heizel Esplanade Heysel b 22
B-1020 Brussel

PharmaCoDane ApS
Marielundvej 46 A
DK-2730 Herlev

PharmaCoDane ApS
Marielundvej 46 A
DK-2730 Herlev

Stadapharm GmbH
Stadastraße 2-18
D-61118 Bad Vilbel

Stadapharm GmbH
Stadastraße 2-18
D-61118 Bad Vilbel

Felodistad

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodistad

10 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodipine EG
Retard

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodipine EG
Retard

10 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodin

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodin

10 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30, 50,
56, 60, 90, 98, 100,
250, 500, 1 000

10, 14, 20, 28, 30, 50,
56, 60, 90, 98, 100,
250, 500, 1 000

10, 14, 20, 28, 30, 50,
56, 60, 90, 98, 100,
250, 500, 1 000

10, 14, 20, 28, 30, 50,
56, 60, 90, 98, 100,
250, 500, 1 000

10, 14, 20, 28, 30, 50,
56, 60, 90, 98, 100,
250, 500, 1 000

10, 14, 20, 28, 30, 50,
56, 60, 90, 98, 100,
250, 500, 1 000

Felodipin
STADA

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 20

Felodipin
STADA

10 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 20

.

.

2
5
7
2
0
0
3

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

1
7
6
/
4
9