Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 January 2007 to 31 January 2007 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2007-02-23
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, veterinary drug, withdrawal from the market

C 39/18

EN

Official Journal of the European Union

23.2.2007

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 January 2007 to 31 January 2007

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

(2007/C 39/10)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the
decision

Name(s) of the
medicinal
product

22.1.2007

Lucentis

Holder(s) of the marketing authorization

Member State concerned

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 5AB
United Kingdom

This Decision is
addressed to the
Member States

Date of
notification

24.1.2007

24.1.2007

Ciprofloxacin
Kabi

See Annex I

See Annex I

25.1.2007

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

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

ANNEX I

.

.

2
3
2
2
0
0
7

Member State

Netherlands

Netherlands

Netherlands

Marketing
Authorisation Holder

Fresenius Kabi Nederland B.V.
Postbus 2379
5202 CJ 's-Hertogenbosch
Nederland
Tel.: (31) 0800 022 1905
Fax: (31) 0800 022 8295

Fresenius Kabi Nederland B.V.
Postbus 2379
5202 CJ 's-Hertogenbosch
Nederland
Tel.: (31) 0800 022 1905
Fax: (31) 0800 022 8295

Fresenius Kabi Nederland B.V.
Postbus 2379
5202 CJ 's-Hertogenbosch
Nederland
Tel.: (31) 0800 022 1905
Fax: (31) 0800 022 8295

Austria

Austria

Austria

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

E
N

Ciprofloxacin Kabi 100 mg/50 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

100 mg/50 ml

Ciprofloxacin Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

Ciprofloxacin Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

Fresenius Kabi Austria GmbH
Hafnerstraße 36
A-8055 Graz
Tel.: (43) 316 24 95 24
Fax: (43) 316 24 92 70

Fresenius Kabi Austria GmbH
Hafnerstraße 36
A-8055 Graz
Tel.: (43) 316 24 95 24
Fax: (43) 316 24 92 70

Fresenius Kabi Austria GmbH
Hafnerstraße 36
A-8055 Graz
Tel.: (43) 316 24 95 24
Fax: (43) 316 24 92 70

Ciprofloxacin Kabi 100 mg/50 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

100 mg/50 ml

Ciprofloxacin Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

Ciprofloxacin Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

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

3
9
/
1
9

Member State

Belgium

Marketing
Authorisation Holder

Belgium

Cyprus

Cyprus

Cyprus

Czech
Republic

Czech
Republic

Fresenius Kabi N.V.
Molenberglei 7
B-2627 Schelle
Tel.: (32-3) 880 50 24
Fax: (32-3) 880 28 88

Fresenius Kabi N.V.
Molenberglei 7
B-2627 Schelle
Tel.: (32-3) 880 50 24
Fax: (32-3) 880 28 88

Fresenius Kabi Hellas A.E.
354 Messogion Avenue
GR-15341 Agia Paraskevi Attica
Tel.: (30) 21 06 54 29 09
Fax: (30) 21 06 54 89 09

Fresenius Kabi Hellas A.E.
354 Messogion Avenue
GR-15341 Agia Paraskevi Attica
Tel.: (30) 21 06 54 29 09
Fax: (30) 21 06 54 89 09

Fresenius Kabi Hellas A.E.
354 Messogion Avenue
GR-15341 Agia Paraskevi Attica
Tel.: (30) 21 06 54 29 09
Fax: (30) 21 06 54 89 09

Fresenius Kabi Nederland B.V.
Postbus 2379
5202 CJ 's-Hertogenbosch
Nederland
Tel.: (31) 800 022 1905
Fax: (31) 0800 022 8295

Fresenius Kabi Nederland B.V.
Postbus 2379
5202 CJ 's-Hertogenbosch
Nederland
Tel.: (31) 800 022 1905
Fax: (31) 0800 022 8295

Applicant

Name

Strength

Pharmaceutical Form

Ciprofloxacin Fresenius Kabi 200 mg/
100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Route of
administration

Content
(concentration)

Intravenous use

200 mg/100 ml

Ciprofloxacin Fresenius Kabi 400 mg/
200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

Ciprofloxacin Kabi 100 mg/50 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

100 mg/50 ml

Ciprofloxacin Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

Ciprofloxacin Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

Ciprofloxacin Kabi 100 mg/50 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

100 mg/50 ml

Ciprofloxacin Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

C

3
9
/
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

.

.

2
3
2
2
0
0
7

Member State

Marketing
Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Czech
Republic

Germany

Germany

Germany

Denmark

Greece

Greece

Greece

Fresenius Kabi Nederland B.V.
Postbus 2379
5202 CJ 's-Hertogenbosch
Nederland
Tel.: (31) 800 022 1905
Fax: (31) 0800 022 8295

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Tel.: (49) 6172 686-0
Fax: (49) 6172 686 73 32

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Tel.: (49) 6172 686-0
Fax: (49) 6172 686 73 32

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Tel.: (49) 6172 686-0
Fax: (49) 6172 686 73 32

Fresenius Kabi AB
S-75174 Uppsala
Tlf. nr (46) 18 644 000
Fax nr (46) 18 644 013

Fresenius Kabi Hellas A.E.
354 Messogion Avenue
GR-15341 Agia Paraskevi Attica
Tel.: (30) 21 06 54 29 09
Fax: (30) 21 06 54 89 09

Fresenius Kabi Hellas A.E.
354 Messogion Avenue
GR-15341 Agia Paraskevi Attica
Tel.: (30) 21 06 54 29 09
Fax: (30) 21 06 54 89 09

Fresenius Kabi Hellas A.E.
354 Messogion Avenue
GR-15341 Agia Paraskevi Attica
Tel.: (30) 21 06 54 29 09
Fax: (30) 21 06 54 89 09

Ciprofloxacin Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

Ciprofloxacin Kabi 100 mg/50 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

100 mg/50 ml

Ciprofloxacin Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

Ciprofloxacin Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

Ciprofloxacin Fresenius Kabi 2 mg/
ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml,
400 mg/200 ml

Ciprofloxacin Kabi 100 mg/50 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

100 mg/50 ml

Ciprofloxacin Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

Ciprofloxacin Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

.

.

2
3
2
2
0
0
7

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

3
9
/
2
1

Member State

Marketing
Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Spain

Finland

Hungary

Hungary

Italy

Italy

Italy

Poland

Fresenius Kabi España S.A.
c./ Marina 16-18, planta 17
E-08005 Barcelona
Tel.: (0034-93) 225 65 80
Fax: (0034-93) 225 65 73

Fresenius Kabi AB
S-75174 Uppsala
Tlf nr: 0046 18 644 000
Fax nr: 0046 18 644 013

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Tel.: (49) 6172 686-0
Fax: (49) 6172 686 73 32

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Tel.: (49) 6172 686-0
Fax: (49) 6172 686 73 32

Fresenius Kabi Italia S.r.L.
via Camagre 41
I-37063 Isola della Scala (VR)
Tel.: 0039 0456 64 93 11
Fax: 0039 0456 64 94 04

Fresenius Kabi Italia S.r.L.
via Camagre 41
I-37063 Isola della Scala (VR)
Tel.: 0039 0456 64 93 11
Fax: 0039 0456 64 94 04

Fresenius Kabi Italia S.r.L.
via Camagre 41
I-37063 Isola della Scala (VR)
Tel.: 0039 0456 64 93 11
Fax: 0039 0456 64 94 04

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Tel.: (49) 6172 686-0
Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 2 mg/ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml,
400 mg/200 ml

Ciprofloxacin Fresenius Kabi 2 mg/
ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml,
400 mg/200 ml

Ciprofloxacin Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

Ciprofloxacin Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

Ciprofloxacin Kabi 100 mg/50 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

100 mg/50 ml

Ciprofloxacin Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

Ciprofloxacin Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

Ciprofloxacin Kabi 100 mg/50 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

100 mg/50 ml

C

3
9
/
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

.

.

2
3
2
2
0
0
7

Member State

Poland

Marketing
Authorisation Holder

Poland

Portugal

Portugal

Portugal

Sweden

Slovak
Republic

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Tel.: (49) 6172 686-0
Fax: (49) 6172 686 73 32

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Tel.: (49) 6172 686-0
Fax: (49) 6172 686 73 32

Fresenius Kabi Pharma Portugal Lda.
Avenida do Forte 3
Edifício Suécia IV
Piso 3
P-94-039 Carnaxide
Tel.: (00351) 214 24 12 84
Fax: (00351) 214 24 12 90

Fresenius Kabi Pharma Portugal Lda.
Avenida do Forte 3
Edifício Suécia IV
Piso 3
P-794-039 Carnaxide
Tel.: (00351) 214 24 12 84
Fax: (00351) 214 24 12 90

Fresenius Kabi Pharma Portugal Lda.
Avenida do Forte 3
Edifício Suécia IV
Piso 3
P-94-039 Carnaxide
Tel.: (00351) 214 24 12 84
Fax: (00351) 214 24 12 90

Fresenius Kabi AB
S-75174 Uppsala
Tfn nr (46) 18 644 000
Fax nr (46) 18 644 013

Fresenius Kabi Deutschland GmbH,
D-61346 Bad Homburg v.d.H.
Tel.: (49) 6172 686-0
Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

Ciprofloxacin Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

Ciprofloxacin Kabi 100 mg/50 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

100 mg/50 ml

Ciprofloxacin Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

Ciprofloxacin Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

Ciprofloxacin Fresenius Kabi 2 mg/
ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml,
400 mg/200 ml

Ciprofloxacin Kabi 100 mg/50 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

100 mg/50 ml

.

.

2
3
2
2
0
0
7

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

3
9
/
2
3

Member State

Marketing
Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

Content
(concentration)

C

3
9
/
2
4

Slovak
Republic

Slovak
Republic

United
Kingdom

United
Kingdom

United
Kingdom

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Tel.: (49) 6172 686-0
Fax: (49) 6172 686 73 32

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Tel.: (49) 6172 686-0
Fax: (49) 6172 686 73 32

Fresenius Kabi Limited Cestrian Court
Eastgate Way Manor Park
Runcorn Cheshire WA7 1NT
United Kingdom
Tel.: (44-19) 28 59 42 21
Fax: (44-19) 28 59 43 14

Fresenius Kabi Limited Cestrian Court
Eastgate Way Manor Park
Runcorn Cheshire WA7 1NT
United Kingdom
Tel.: (44-19) 28 59 42 21
Fax: (44-19) 28 59 43 14

Fresenius Kabi Limited Cestrian Court
Eastgate Way Manor Park
Runcorn Cheshire WA7 1NT
United Kingdom
Tel.: (44-19) 28 59 42 21
Fax: (44-19) 28 59 43 14

Ciprofloxacin Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

Ciprofloxacin Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

E
N

Ciprofloxacine Kabi 100 mg/50 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

100 mg/50 ml

Ciprofloxacine Kabi 200 mg/100 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

200 mg/100 ml

Ciprofloxacine Kabi 400 mg/200 ml,
solution for infusion

2 mg/ml

Solution for infu-
sion

Intravenous use

400 mg/200 ml

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
3
2
2
0
0
7