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Document 52015XC0626(02)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2015 to 31 May 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2015. gada 1. maija līdz 2015. gada 31. maijam (Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)
Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2015. gada 1. maija līdz 2015. gada 31. maijam (Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)
OV C 211, 26.6.2015, p. 1–9
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
26.6.2015 |
LV |
Eiropas Savienības Oficiālais Vēstnesis |
C 211/1 |
Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2015. gada 1. maija līdz 2015. gada 31. maijam
(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 (1) 13. vai 38. pantu)
(2015/C 211/01)
— Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas
|
Lēmuma datums |
Zāļu nosaukums |
INN (starptautiskais nepatentētais nosaukums) |
Tirdzniecības atļaujas turētājs |
Ieraksta numurs Kopienas reģistrā |
Farmaceitiskā forma |
AĶT kods (Anatomiski ķīmiski terapeitiskais kods) |
Paziņojuma datums |
|
6.5.2015. |
Zykadia |
ceritiniba |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/999 |
Cietās kapsulas |
L01XE |
8.5.2015. |
|
27.5.2015. |
Akynzeo |
Netupitant/Palonosetron |
Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland |
EU/1/15/1001 |
Cietās kapsulas |
A04AA55 |
29.5.2015. |
|
27.5.2015. |
Jinarc |
tolvaptan |
Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/15/1000 |
Tabletes |
Pending |
29.5.2015. |
|
27.5.2015. |
Synjardy |
empagliflozīns/metformīns |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/15/1003 |
Apvalkotās tabletes |
A10BD20 |
29.5.2015. |
|
27.5.2015. |
Voriconazole Hospira |
Voriconazole |
Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
EU/1/15/1004 |
Pulveris infūziju šķīduma pagatavošanai |
J02AC03 |
29.5.2015. |
|
28.5.2015. |
Lenvima |
lenvatinib |
Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |
EU/1/15/1002 |
Cietās kapsulas |
L01XE29 |
1.6.2015. |
— Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas
|
Lēmuma datums |
Zāļu nosaukums |
Tirdzniecības atļaujas turētājs |
Ieraksta numurs Kopienas reģistrā |
Paziņojuma datums |
|
5.5.2015. |
Copalia |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/372 |
7.5.2015. |
|
5.5.2015. |
Copalia HCT |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/575 |
7.5.2015. |
|
5.5.2015. |
Dafiro |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/371 |
7.5.2015. |
|
5.5.2015. |
Dafiro HCT |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/574 |
7.5.2015. |
|
5.5.2015. |
Erivedge |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/13/848 |
8.5.2015. |
|
5.5.2015. |
Exforge |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/370 |
7.5.2015. |
|
5.5.2015. |
Exforge HCT |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/569 |
7.5.2015. |
|
5.5.2015. |
Imprida |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/373 |
7.5.2015. |
|
5.5.2015. |
INCRELEX |
Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France |
EU/1/07/402 |
7.5.2015. |
|
5.5.2015. |
Irbesartan/Hydrochlorothiazide Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/583 |
8.5.2015. |
|
5.5.2015. |
Orfadin |
Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige |
EU/1/04/303 |
8.5.2015. |
|
5.5.2015. |
Sycrest |
Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland |
EU/1/10/640 |
7.5.2015. |
|
5.5.2015. |
Tamiflu |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/02/222 |
8.5.2015. |
|
5.5.2015. |
Telzir |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/04/282 |
7.5.2015. |
|
5.5.2015. |
Tyverb |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/440 |
7.5.2015. |
|
5.5.2015. |
Voncento |
CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/13/857 |
7.5.2015. |
|
5.5.2015. |
Votrient |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/628 |
7.5.2015. |
|
5.5.2015. |
Zoledronic acid Teva Pharma |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/772 |
7.5.2015. |
|
5.5.2015. |
Zypadhera |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/08/479 |
7.5.2015. |
|
6.5.2015. |
Arzerra |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/625 |
8.5.2015. |
|
6.5.2015. |
Celsentri |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/07/418 |
8.5.2015. |
|
6.5.2015. |
Celvapan |
Baxter AG Industriestraße 67, A-1221 Wien, Österreich |
EU/1/08/506 |
8.5.2015. |
|
6.5.2015. |
Clopidogrel Krka |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/09/556 |
8.5.2015. |
|
6.5.2015. |
Imatinib Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/808 |
8.5.2015. |
|
6.5.2015. |
Optaflu |
Novartis Influenza Vaccines Marburg GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/07/394 |
8.5.2015. |
|
6.5.2015. |
Revolade |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/612 |
8.5.2015. |
|
6.5.2015. |
Tafinlar |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/13/865 |
8.5.2015. |
|
13.5.2015. |
Cayston |
Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom |
EU/1/09/543 |
19.5.2015. |
|
13.5.2015. |
Efficib |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/08/457 |
19.5.2015. |
|
13.5.2015. |
Granupas |
Lucane Pharma 172 rue de Charonne, 75011 Paris, France |
EU/1/13/896 |
19.5.2015. |
|
13.5.2015. |
Janumet |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/08/455 |
19.5.2015. |
|
13.5.2015. |
Leflunomide ratiopharm |
ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/10/654 |
19.5.2015. |
|
13.5.2015. |
Luminity |
Lantheus MI UK Limited Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom |
EU/1/06/361 |
19.5.2015. |
|
13.5.2015. |
Memantine Merz |
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland |
EU/1/12/799 |
19.5.2015. |
|
13.5.2015. |
Ovitrelle |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/00/165 |
19.5.2015. |
|
13.5.2015. |
Trizivir |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/00/156 |
19.5.2015. |
|
13.5.2015. |
Velmetia |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/08/456 |
19.5.2015. |
|
13.5.2015. |
Vyndaqel |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/11/717 |
19.5.2015. |
|
27.5.2015. |
Aflunov |
Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia |
EU/1/10/658 |
29.5.2015. |
|
27.5.2015. |
Ariclaim |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/04/283 |
29.5.2015. |
|
27.5.2015. |
Brinavess |
Cardiome UK Limited Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom |
EU/1/10/645 |
29.5.2015. |
|
27.5.2015. |
Clopidogrel TAD |
TAD Pharma GmbH Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland |
EU/1/09/555 |
29.5.2015. |
|
27.5.2015. |
Cometriq |
TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom |
EU/1/13/890 |
29.5.2015. |
|
27.5.2015. |
Cymbalta |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/04/296 |
29.5.2015. |
|
27.5.2015. |
Erivedge |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/13/848 |
29.5.2015. |
|
27.5.2015. |
Esmya |
Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország |
EU/1/12/750 |
29.5.2015. |
|
27.5.2015. |
Foclivia |
Novartis Vaccines Influenza S.r.l. Via Fiorentina, 1, 53100 Siena, Italia |
EU/1/09/577 |
29.5.2015. |
|
27.5.2015. |
Gardasil |
Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/06/357 |
29.5.2015. |
|
27.5.2015. |
Imnovid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/13/850 |
29.5.2015. |
|
27.5.2015. |
INCRELEX |
Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France |
EU/1/07/402 |
29.5.2015. |
|
27.5.2015. |
Jentadueto |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/12/780 |
29.5.2015. |
|
27.5.2015. |
Levemir |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/04/278 |
29.5.2015. |
|
27.5.2015. |
Levetiracetam Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/11/712 |
29.5.2015. |
|
27.5.2015. |
Myclausen |
Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, D-14167 Berlin, Deutschland |
EU/1/10/647 |
29.5.2015. |
|
27.5.2015. |
Nexium Control |
Pfizer Consumer Healthcare Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
EU/1/13/860 |
29.5.2015. |
|
27.5.2015. |
Nivestim |
Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
EU/1/10/631 |
29.5.2015. |
|
27.5.2015. |
Prepandrix |
GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique |
EU/1/08/453 |
29.5.2015. |
|
27.5.2015. |
Raloxifene Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/10/627 |
29.6.2015. |
|
27.5.2015. |
Relistor |
TMC Pharma Services Ltd Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom |
EU/1/08/463 |
29.5.2015. |
|
27.5.2015. |
Resolor |
Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/09/581 |
29.5.2015. |
|
27.5.2015. |
Selincro |
H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark |
EU/1/12/815 |
29.5.2015. |
|
27.5.2015. |
Silgard |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/06/358 |
29.5.2015. |
|
27.5.2015. |
Sonata |
Meda AB Pipers väg 2A, S-170 09 Solna, Sverige |
EU/1/99/102 |
29.5.2015. |
|
27.5.2015. |
Sovaldi |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/13/894 |
29.5.2015. |
|
27.5.2015. |
Targretin |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/01/178 |
29.5.2015. |
|
27.5.2015. |
Temodal |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/98/096 |
29.5.2015. |
|
27.5.2015. |
Temozolomide Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/10/615 |
29.5.2015. |
|
27.5.2015. |
Thalidomide Celgene |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/08/443 |
29.5.2015. |
|
27.5.2015. |
Tolucombi |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/13/821 |
29.5.2015. |
|
27.5.2015. |
Volibris |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/08/451 |
29.5.2015. |
|
27.5.2015. |
Xeristar |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/04/297 |
29.5.2015. |
|
27.5.2015. |
Xtandi |
Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EU/1/13/846 |
29.5.2015. |
|
27.5.2015. |
Yentreve |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/04/280 |
29.5.2015. |
|
27.5.2015. |
Yondelis |
Pharma Mar S.A. Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España |
EU/1/07/417 |
29.5.2015. |
|
28.5.2015. |
Aclasta |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/05/308 |
1.6.2015. |
|
28.5.2015. |
alli |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/07/401 |
1.6.2015. |
|
28.5.2015. |
Dificlir |
Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EU/1/11/733 |
1.6.2015. |
|
28.5.2015. |
Invega |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/07/395 |
1.6.2015. |
|
28.5.2015. |
Januvia |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/383 |
1.6.2015. |
|
28.5.2015. |
Lonquex |
UAB “Sicor Biotech” Molėtų pl. 5, LT-08409 Vilnius, Lietuva |
EU/1/13/856 |
1.6.2015. |
|
28.5.2015. |
Ristaben |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/10/621 |
1.6.2015. |
|
28.5.2015. |
Topotecan Hospira |
Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
EU/1/10/633 |
1.6.2015. |
|
28.5.2015. |
Tygacil |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/336 |
1.6.2015. |
— Tirdzniecības atļaujas izņemšana no aprites (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants)
|
Lēmuma datums |
Zāļu nosaukums |
Tirdzniecības atļaujas turētājs |
Ieraksta numurs Kopienas reģistrā |
Paziņojuma datums |
|
5.5.2015. |
Clopidogrel DURA |
Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland |
EU/1/09/560 |
7.5.2015. |
|
6.5.2015. |
Provenge |
Dendreon UK Limited 41 Chalton Street, London NW1 1JD, United Kingdom |
EU/1/13/867 |
8.5.2015. |
— Tirdzniecības atļaujas grozīšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas
|
Lēmuma datums |
Zāļu nosaukums |
Tirdzniecības atļaujas turētājs |
Ieraksta numurs Kopienas reģistrā |
Paziņojuma datums |
|
5.5.2015. |
MS-H Vaccine |
Pharmsure International Ltd Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom |
EU/2/11/126 |
7.5.2015. |
|
5.5.2015. |
Purevax RCP |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/04/052 |
7.5.2015. |
|
13.5.2015. |
Nobilis IB 4-91 |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/98/006 |
19.5.2015. |
|
13.5.2015. |
Rheumocam |
Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland |
EU/2/07/078 |
19.5.2015. |
|
27.5.2015. |
Meloxivet |
Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom |
EU/2/07/077 |
29.5.2015. |
|
27.5.2015. |
Purevax FeLV |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/00/019 |
29.5.2015. |
|
27.5.2015. |
Purevax RCPCh |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/04/050 |
29.5.2015. |
|
27.5.2015. |
Suprelorin |
VIRBAC S.A. 1ère Avenue – 2065 m – L.I.D., F-06516 Carros CEDEX, France |
EU/2/07/072 |
29.5.2015. |
Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:
|
The European Medicines Agency |
|
30, Churchill Place, Canary Wharf |
|
UK – LONDON E14 5EU |
(1) OV L 136, 30.4.2004., 1. lpp.