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`Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September
`2005 to 30 September 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
`
`
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`English (en)
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`28.10.2005
`
`EN
`
`Official Journal of the European Union
`
`C 268/2
`
`Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2005 to 30
`September 2005
`
`(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93 (1))
`(2005/C 268/02)
`
`— Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93): Accepted
`
`Date of the
`decision
`
`Name of the
`medicinal
`product
`
`19.9.2005
`
`Tarceva
`
`Holder of the marketing
`authorization
`
`Number of the entry in the Community
`Register
`
`Date of notification
`
`Roche Registration Limited, 40
`Broadwater Road, Welwyn Garden
`City, UKHertfordshire AL7 3AY
`
`EU/1/05/311/001003
`
`21.9.2005
`
`— Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93): Accepted
`
`Date of the
`decision
`
`Name of the
`medicinal
`product
`
`5.9.2005
`
`Ventavis
`
`5.9.2005
`
`Trazec
`
`5.9.2005
`
`Forsteo
`
`5.9.2005
`
`Starlix
`
`Holder of the marketing
`authorization
`
`Schering AG, Müllerstraße
`170178, DE13342 Berlin
`
`Novartis Europharm
`Limited, Wimblehurst Road,
`Horsham, UKWest Sussex
`RH12 5AB
`
`Eli Lilly Nederland B.V.,
`Grootslag 15, NL3991 RA
`Houten
`
`Novartis Europharm
`Limited, Wimblehurst Road,
`Horsham, UKWest Sussex
`RH12 5AB
`
`Number of the entry in the Community Register
`
`Date of
`notification
`
`EU/1/03/255//001003
`
`EU/1/01/175/001021
`
`EU/1/03/247/001002
`
`EU/1/01/174/001021
`
`8.9.2005
`
`8.9.2005
`
`7.9.2005
`
`8.9.2005
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1044, p. 1 of 5
`
`Title and reference
`OJ C 268, 28.10.2005, p. 2–6 (ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, NL, PL, PT, SK, SL, FI, SV)
`Languages, formats and link to OJ
`BG ES CS DA DE
`ET
`EL
`EN FR GA HR
`IT
`LV
`LT HU MT NL
`PL
`PT
`RO SK
`SL
`FI
`SV
`HTML
`Official
`Journal
`Multilingual display
`
`
`
`Text
`
`
`7.9.2005
`
`DaTSCAN
`
`7.9.2005
`
`Emtriva
`
`RH12 5AB
`
`GE Healthcare Limited, UK
`Little Chalfont Bucks HP7
`9NA
`
`Gilead Sciences International
`Limited, UKCambridge
`CB1 6GT
`
`7.9.2005
`
`KOGENATE Bayer Bayer AG, DE51368
`Leverkusen
`
`EU/1/00/135/001002
`
`EU/1/03/261/001003
`
`EU/1/00/143/001006
`
`EU/1/00/144/001003
`
`EU/1/01/184/001056
`
`EU/1/00/145/001
`
`EU/1/04/295/001
`
`EU/1/04/298/001002
`
`Bayer AG, DE51368
`Leverkusen
`
`Dompé Biotec S.p.A., Via
`San Martino, 12, IT20122
`Milano
`
`Roche Registration Limited,
`40 Broadwater Road,
`Welwyn Garden City, UK
`Hertfordshire AL7 3AY
`
`Shire Pharmaceutical
`Contracts Ltd, Hampshire
`International Business Park,
`Chineham, Basingstoke,
`UKHampshire RG24 8EP
`
`Glaxo Group Ltd, Berkeley
`Avenue, Greenford, UK
`Middlesex UB6 0NN
`
`7.9.2005
`
`Helixate NexGen
`
`8.9.2005
`
`Nespo
`
`8.9.2005
`
`Herceptin
`
`8.9.2005
`
`Xagrid
`
`8.9.2005
`
`Kivexa
`
`8.9.2005
`
`Ziagen
`
`8.9.2005
`
`Aranesp
`
`8.9.2005
`
`Karvezide
`
`8.9.2005
`
`CoAprovel
`
`8.9.2005
`
`PegIntron
`
`8.9.2005
`
`ViraferonPeg
`
`8.9.2005
`
`Raptiva
`
`8.9.2005
`
`Pylobactell
`
`13.9.2005
`
`Infanrix Hexa
`
`Glaxo Group Ltd, Greenford,
`UKMiddlesex UB6 0NN
`
`EU/1/99/112/001002
`
`Amgen Europe B.V.,
`Minervum 7061, NL4817
`ZK Breda
`
`BristolMyers Squibb
`Pharma EEIG, Uxbridge
`Business Park, Sanderson
`Road, UKUxbridge UD8
`1DH
`
`Sanofi Pharma Bristol
`Myers Squibb SNC, 174
`avenue de France, FR75013
`Paris
`
`Schering Plough Europe,
`Rue de Stalle, 73, BE1180
`Bruxelles — Stallestraat, 73,
`BE1180 Brussel
`
`Schering Plough Europe,
`Rue de Stalle, 73, BE1180
`Bruxelles — Stallestraat, 73,
`BE1180 Brussel
`
`Serono Europe Limited, 56,
`Marsh Wall, UKLondon
`E14 9TP
`
`Torbet Laboratories Limited,
`Unit 14D, Wendover Road,
`Rackheath Industrial Estate,
`Norwich, UKNorfolk NR13
`6LH
`
`GlaxoSmithKline Biologicals
`S.A., rue de l'Institut 89,
`BE1330 Rixensart
`
`EU/1/01/185/001056
`
`EU/1/98/085/001020
`
`EU/1/98/086/001020
`
`EU/1/00/131/001050
`
`EU/1/00/132/001050
`
`EU/1/04/291/001002
`
`EU/1/98/064/001
`
`EU/1/00/152/001018
`
`13.9.2005
`
`Somavert
`
`Pfizer Limited, Sandwich,
`UKKent, CT13 9NJ
`
`EU/1/02/240/001004
`
`9.9.2005
`
`9.9.2005
`
`9.9.2005
`
`9.9.2005
`
`13.9.2005
`
`13.9.2005
`
`13.9.2005
`
`13.9.2005
`
`13.9.2005
`
`13.9.2005
`
`13.9.2005
`
`13.9.2005
`
`13.9.2005
`
`13.9.2005
`
`14.9.2005
`
`13.9.2005
`
`14.9.2005
`
`14.9.2005
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1044, p. 2 of 5
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`
`
`13.9.2005
`
`Hepsera
`
`13.9.2005
`
`Erbitux
`
`13.9.2005
`
`Dynepo
`
`13.9.2005
`
`Infanrix Penta
`
`13.9.2005
`
`Mimpara
`
`13.9.2005
`
`Avandamet
`
`13.9.2005
`
`Karvea
`
`13.9.2005
`
`Keppra
`
`13.9.2005
`
`Keppra
`
`13.9.2005
`
`Aprovel
`
`15.9.2005
`
`Hepsera
`
`15.9.2005
`
`Cymbalta
`
`15.9.2005
`
`Ariclaim
`
`15.9.2005
`
`Yentreve
`
`15.9.2005
`
`Xeristar
`
`15.9.2005
`
`Bonviva
`
`EU/1/03/251/001
`
`EU/1/04/281/001
`
`EU/1/02/211/001009
`
`EU/1/00/153/001010
`
`EU/1/04/292/001012
`
`EU/1/03/258/013014
`
`EU/1/97/049/001030
`
`EU/1/00/146/001029
`
`EU/1/00/146/001027
`
`EU/1/97/046/001030
`
`EU/1/03/251/001
`
`EU/1/04/296/001006
`
`EU/1/04/283/001007
`
`EU/1/04/280/001007
`
`EU/1/04/297/001006
`
`EU/1/03/265/003004
`
`Gilead Sciences International
`Limited, UKCambridge
`CB1 6GT
`
`Merck KGaA, Frankfurter
`Straße 250, DE64293
`Darmstadt
`
`Shire Pharmaceutical
`Contracts Ltd, Hampshire
`International Business Park,
`Chineham, Basingstoke,
`UKHampshire RG24 8EP
`Aventis Pharma S.A., 20
`Avenue Raymond Aron,
`Antony Cedex FR92165
`
`GlaxoSmithKline Biologicals
`s.a., rue de l'Institut 89, BE
`1330 Rixensart
`
`Amgen Europe B.V.,
`Minervum 7061, NL4817
`ZK Breda
`
`SmithKline Beecham plc,
`980 Great West Road,
`Brentford, UKMiddlesex
`TW8 9GS
`
`BristolMyers Squibb
`Pharma EEIG, 141149
`Staines Road, UKHounslow
`TW3 3JA
`
`UCB S.A., Allée de la
`recherche, 60, BE1070
`Bruxelles — Researchdreef,
`60, BE1070 Brussel
`
`UCB S.A., Allée de la
`recherche, 60, BE1070
`Bruxelles — Researchdreef,
`60, BE1070 Brussel
`
`Sanofi Pharma Bristol
`Myers Squibb SNC, 174
`avenue de France, FR75013
`Paris
`
`Gilead Sciences International
`Limited, UKCambridge
`CB1 6GT
`
`Eli Lilly Nederland BV,
`Grootslag 15, NL3991 RA
`Houten
`
`Boehringer Ingelheim
`International GmbH, Binger
`Straße 173, DE55216
`Ingelheim am Rhein
`
`Eli Lilly Nederland B.V.,
`Grootslag 15, NL3991 RA
`Houten
`
`Boehringer Ingelheim
`International GmbH, Binger
`Straße 173, DE55216
`Ingelheim am Rhein
`
`Roche Registration Limited,
`40 Broadwater Road,
`Welwyn Garden City, UK
`Hertfordshire AL7 3AY
`
`15.9.2005
`
`Bondenza
`
`Roche Registration Limited, EU/1/03/266/003004
`
`15.9.2005
`
`14.9.2005
`
`15.9.2005
`
`14.9.2005
`
`14.9.2005
`
`14.9.2005
`
`15.9.2005
`
`16.9.2005
`
`16.9.2005
`
`15.9.2005
`
`20.9.2005
`
`20.9.2005
`
`20.9.2005
`
`20.9.2005
`
`20.9.2005
`
`20.9.2005
`
`20.9.2005
`
`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1044, p. 3 of 5
`
`
`
`15.9.2005
`
`Bondenza
`
`15.9.2005
`
`Myocet
`
`15.9.2005
`
`NovoMix
`
`16.9.2005
`
`REYATAZ
`
`19.9.2005
`
`Ariclaim
`
`19.9.2005
`
`Arava
`
`19.9.2005
`
`Yentreve
`
`19.9.2005
`
`Hexavac
`
`22.9.2005
`
`Iscover
`
`22.9.2005
`
`Plavix
`
`29.9.2005
`
`Remicade
`
`Roche Registration Limited,
`40 Broadwater Road,
`Welwyn Garden City, UK
`Hertfordshire AL7 3AY
`
`Elan Pharma International
`Ltd., WIL House, Shannon
`Business Park, Shannon, IE
`County Clare
`
`Novo Nordisk A/S, Novo
`Allé, DK2880 Bagsvaerd
`
`BristolMyers Squibb
`Pharma EEIG, 141149
`Staines Road, UKHounslow
`TW3 3JA
`
`Boehringer Ingelheim
`International GmbH, Binger
`Straße 173, DE55216
`Ingelheim am Rhein
`
`Aventis Pharma Deutschland
`GmbH, DE65926 Frankfurt
`am Main
`
`Eli Lilly Nederland B.V.,
`Grootslag 15, NL3991 RA
`Houten
`
`Sanofi Pasteur MSD, SNC,
`8, rue Jonas Salk, FR69007
`Lyon
`
`BristolMyers Squibb
`Pharma EEIG, Uxbridge
`Business Park, Sanderson
`Road, UKUxbridge UD8
`1DH
`
`Sanofi Pharma Bristol
`Myers Squibb SNC, 174
`avenue de France, FR75013
`Paris
`
`Centocor B.V., Einsteinweg
`101, NL2333 CB Leiden
`
`EU/1/03/266/003004
`
`EU/1/00/141/001
`
`EU/1/00/142/004005
`EU/1/00/142/009010
`
`EU/1/03/267/001007
`
`EU/1/04/283/001007
`
`EU/1/99/118/001010
`
`EU/1/04/280/001007
`
`EU/1/00/147/001012
`
`EU/1/98/070/001a — 001b
`EU/1/98/070/002a — 002b
`EU/1/98/070/003a — 003b
`EU/1/98/070/004a — 001b
`
`EU/1/98/069/001a — 001b
`EU/1/98/069/002a — 002b
`EU/1/98/069/003a — 003b
`EU/1/98/069/004a — 001b
`
`EU/1/99/116/001003
`
`20.9.2005
`
`20.9.2005
`
`20.9.2005
`
`20.9.2005
`
`21.9.2005
`
`21.9.2005
`
`21.9.2005
`
`21.9.2005
`
`26.9.2005
`
`26.9.2005
`
`4.10.2005
`
`— Withdrawal of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93)
`
`Date of the
`decision
`
`Name of the
`medicinal product
`
`Holder of the marketing
`authorization
`
`Number of the entry in the
`Community Register
`
`Date of notification
`
`22.9.2005
`
`CEAScan
`
`Immunomedics GmbH, OttoRöhm
`Straße 69, DE64293 Darmstadt
`
`EU/1/96/023/001
`
`27.9.2005
`
`— Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93): Accepted
`
`Date of the
`decision
`
`Name of the
`medicinal product
`
`Holder of the marketing
`authorization
`
`Number of the entry in the Community
`Register
`
`Date of notification
`
`19.9.2005
`
`Pirsue
`
`PFIZER Ltd, Ramsgate
`Road, Sandwich, UKKent
`CT13 9NJ
`
`EU/2/00/027/001003
`
`21.9.2005
`
`Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to
`contact:
`The European Medicines Agency
`7, Westferry Circus, Canary Wharf
`UKLondon E14 4HB
`
`(1) OJ L 214 of 24.8.1993, p. 1.
`
`Top
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1044, p. 4 of 5
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1044, p. 5 of 5
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1044, p. 5 of 5
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