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Document 52007XC0223(02)

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)

IO C 39, 23.2.2007, p. 18–24 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, RO, SK, SL, FI, SV)

Date of document:
23/02/2007; Dáta foilsithe
Author:
An Coimisiún Eorpach
Form:
Teachtaireacht
Treaty:
An Conradh ag bunú an Chomhphobail Eorpaigh
Legal basis:
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23.2.2007   

EN

Official Journal of the European Union

C 39/18

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

Holder(s) of the marketing authorization

Member State concerned

Date of notification

22.1.2007

Lucentis

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

This Decision is addressed to the Member States

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.

ANNEX I

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

Member State

Marketing

Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Netherlands

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 0800 022 1905

Fax: (31) 0800 022 8295

 

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Netherlands

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 0800 022 1905

Fax: (31) 0800 022 8295

 

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Netherlands

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 0800 022 1905

Fax: (31) 0800 022 8295

 

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Austria

 

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 infusion

Intravenous use

100 mg/50 ml

Austria

 

Fresenius Kabi Austria GmbH

Hafnerstraße 36

A-8055 Graz

Tel.: (43) 316 24 95 24

Fax: (43) 316 24 92 70

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Austria

 

Fresenius Kabi Austria GmbH

Hafnerstraße 36

A-8055 Graz

Tel.: (43) 316 24 95 24

Fax: (43) 316 24 92 70

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Belgium

 

Fresenius Kabi N.V.

Molenberglei 7

B-2627 Schelle

Tel.: (32-3) 880 50 24

Fax: (32-3) 880 28 88

Ciprofloxacin Fresenius Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Belgium

 

Fresenius Kabi N.V.

Molenberglei 7

B-2627 Schelle

Tel.: (32-3) 880 50 24

Fax: (32-3) 880 28 88

Ciprofloxacin Fresenius Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Cyprus

 

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 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Cyprus

 

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 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Cyprus

 

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 infusion

Intravenous use

400 mg/200 ml

Czech Republic

 

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 800 022 1905

Fax: (31) 0800 022 8295

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Czech Republic

 

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 800 022 1905

Fax: (31) 0800 022 8295

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Czech Republic

 

Fresenius Kabi Nederland B.V.

Postbus 2379

5202 CJ 's-Hertogenbosch

Nederland

Tel.: (31) 800 022 1905

Fax: (31) 0800 022 8295

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Germany

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Germany

 

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 infusion

Intravenous use

200 mg/100 ml

Germany

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Denmark

 

Fresenius Kabi AB

S-75174 Uppsala

Tlf. nr (46) 18 644 000

Fax nr (46) 18 644 013

Ciprofloxacin Fresenius Kabi 2 mg/ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml,

400 mg/200 ml

Greece

 

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 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Greece

 

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 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Greece

 

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 infusion

Intravenous use

400 mg/200 ml

Spain

 

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

Ciprofloxacin Kabi 2 mg/ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml,

400 mg/200 ml

Finland

 

Fresenius Kabi AB

S-75174 Uppsala

Tlf nr: 0046 18 644 000

Fax nr: 0046 18 644 013

Ciprofloxacin Fresenius Kabi 2 mg/ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml,

400 mg/200 ml

Hungary

 

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 infusion

Intravenous use

200 mg/100 ml

Hungary

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Italy

 

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

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Italy

 

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

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Italy

 

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

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Poland

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Poland

 

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 infusion

Intravenous use

200 mg/100 ml

Poland

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Portugal

 

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

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Portugal

 

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

Ciprofloxacin Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

Portugal

 

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

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

Sweden

 

Fresenius Kabi AB

S-75174 Uppsala

Tfn nr (46) 18 644 000

Fax nr (46) 18 644 013

Ciprofloxacin Fresenius Kabi 2 mg/ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml,

400 mg/200 ml

Slovak Republic

 

Fresenius Kabi Deutschland GmbH,

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

Slovak Republic

 

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 infusion

Intravenous use

200 mg/100 ml

Slovak Republic

 

Fresenius Kabi Deutschland GmbH

D-61346 Bad Homburg v.d.H.

Tel.: (49) 6172 686-0

Fax: (49) 6172 686 73 32

Ciprofloxacin Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml

United Kingdom

 

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

Ciprofloxacine Kabi 100 mg/50 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

100 mg/50 ml

United Kingdom

 

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

Ciprofloxacine Kabi 200 mg/100 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

200 mg/100 ml

United Kingdom

 

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

Ciprofloxacine Kabi 400 mg/200 ml,

solution for infusion

2 mg/ml

Solution for infusion

Intravenous use

400 mg/200 ml
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