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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)

    OJ 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)

    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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