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Document 52015XC0327(02)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2015 to 28 February 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. februāra līdz 2015. gada 28. februārim (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. februāra līdz 2015. gada 28. februārim (publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)
OV C 104, 27.3.2015, 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)
|
27.3.2015 |
LV |
Eiropas Savienības Oficiālais Vēstnesis |
C 104/1 |
Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2015. gada 1. februāra līdz 2015. gada 28. februārim
(publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 (1) 13. vai 38. pantu)
(2015/C 104/01)
— 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 |
|
17.2.2015. |
Holoclar |
Ex vivo audzētas autologās cilvēka radzenes epitēlija šūnas, kas satur cilmes šūnas |
Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/14/987 |
Dzīvo audu ekvivalents |
S01XA19 |
19.2.2015. |
|
17.2.2015. |
Tyverb |
Lapatinibs |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/07/440 |
Apvalkotās tabletes |
L01XE07 |
19.2.2015. |
|
19.2.2015. |
Clopidogrel ratiopharm |
clopidogrelum |
Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland |
EU/1/14/975 |
Apvalkotās tabletes |
B01AC04 |
24.2.2015. |
|
19.2.2015. |
Xydalba |
Dalbavancīns |
Durata Therapeutics International B.V. Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland |
EU/1/14/986 |
Pulveris infūziju šķīduma koncentrāta pagatavošanai |
J01XA04 |
23.2.2015. |
|
24.2.2015. |
Xadago |
safinamide |
Zambon S.p.A. Via Lillo del Duca 10,20 091 Bresso (MI), Italia |
EU/1/14/984 |
Apvalkotās tabletes |
Pending |
26.2.2015. |
|
26.2.2015. |
Tasermity |
Sevelamēra hidrohlorīds |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/14/953 |
Apvalkotās tabletes |
V03AE02 |
2.3.2015. |
— 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 |
|
3.2.2015. |
Levetiracetam Teva |
Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland |
EU/1/11/701 |
5.2.2015. |
|
3.2.2015. |
Pergoveris |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/07/396 |
6.2.2015. |
|
6.2.2015. |
Adenuric |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg |
EU/1/08/447 |
10.2.2015. |
|
6.2.2015. |
Bridion |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/08/466 |
10.2.2015. |
|
6.2.2015. |
Ceplene |
Meda AB Box 906, SE-170 09 Solna, Sverige |
EU/1/08/477 |
10.2.2015. |
|
6.2.2015. |
Filgrastim Hexal |
Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland |
EU/1/08/496 |
10.2.2015. |
|
6.2.2015. |
Firazyr |
Shire Orphan Therapies GmbH Friedrichstraße 149, D-10117 Berlin, Deutschland |
EU/1/08/461 |
10.2.2015. |
|
6.2.2015. |
Herceptin |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/00/145 |
10.2.2015. |
|
6.2.2015. |
Leflunomide ratiopharm |
ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/10/654 |
10.2.2015. |
|
6.2.2015. |
Levetiracetam SUN |
Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland |
EU/1/11/741 |
10.2.2015. |
|
6.2.2015. |
Opgenra |
Olympus Biotech International Limited 40 Upper Mount Street, Dublin 2, Ireland |
EU/1/08/489 |
10.2.2015. |
|
6.2.2015. |
Raloxifene Teva |
Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland |
EU/1/10/627 |
11.2.2015. |
|
6.2.2015. |
Vimpat |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/08/470 |
10.2.2015. |
|
6.2.2015. |
Zarzio |
Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich |
EU/1/08/495 |
10.2.2015. |
|
10.2.2015. |
Replagal |
Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige |
EU/1/01/189 |
12.2.2015. |
|
10.2.2015. |
Telmisartan Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/610 |
12.2.2015. |
|
10.2.2015. |
Telmisartan Teva Pharma |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/11/719 |
12.2.2015. |
|
10.2.2015. |
Tybost |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/13/872 |
12.2.2015. |
|
11.2.2015. |
Champix |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/360 |
13.2.2015. |
|
11.2.2015. |
HBVAXPRO |
Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/01/183 |
13.2.2015. |
|
11.2.2015. |
Hepsera |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/03/251 |
13.2.2015. |
|
11.2.2015. |
Olanzapine Apotex |
Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland |
EU/1/10/635 |
16.2.2015. |
|
11.2.2015. |
Ribavirin Mylan |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/10/634 |
13.2.2015. |
|
11.2.2015. |
Somavert |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/02/240 |
13.2.2015. |
|
11.2.2015. |
Tyverb |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/07/440 |
13.2.2015. |
|
11.2.2015. |
Vitekta |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/13/883 |
13.2.2015. |
|
11.2.2015. |
Zoledronic acid Hospira |
Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
EU/1/12/800 |
13.2.2015. |
|
12.2.2015. |
Esbriet |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/11/667 |
16.2.2015. |
|
17.2.2015. |
Arzerra |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/10/625 |
19.2.2015. |
|
17.2.2015. |
Lantus |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/00/134 |
19.2.2015. |
|
17.2.2015. |
Oprymea |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/08/469 |
19.2.2015. |
|
17.2.2015. |
Optisulin |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/00/133 |
19.2.2015. |
|
17.2.2015. |
Renagel |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/99/123 |
19.2.2015. |
|
17.2.2015. |
Sutent |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/347 |
19.2.2015. |
|
17.2.2015. |
Vidaza |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom |
EU/1/08/488 |
19.2.2015. |
|
19.2.2015. |
Abilify |
Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/04/276 |
23.2.2015. |
|
19.2.2015. |
EVARREST |
Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België |
EU/1/13/868 |
23.2.2015. |
|
19.2.2015. |
Fertavid |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/09/510 |
23.2.2015. |
|
19.2.2015. |
Memantine Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/880 |
23.2.2015. |
|
19.2.2015. |
Mixtard |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/02/231 |
23.2.2015. |
|
19.2.2015. |
NeuroBloc |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/00/166 |
23.2.2015. |
|
19.2.2015. |
Revlimid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/07/391 |
23.2.2015. |
|
19.2.2015. |
Reyataz |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/03/267 |
23.2.2015. |
|
19.2.2015. |
RotaTeq |
Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/06/348 |
23.2.2015. |
|
19.2.2015. |
Victrelis |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/11/704 |
23.2.2015. |
|
24.2.2015. |
Aloxi |
Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland |
EU/1/04/306 |
26.2.2015. |
|
24.2.2015. |
Eylea |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/12/797 |
26.2.2015. |
|
24.2.2015. |
Hexacima |
Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France |
EU/1/13/828 |
26.2.2015. |
|
24.2.2015. |
Hexyon |
Sanofi Pasteur MSD, SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/13/829 |
26.2.2015. |
|
26.2.2015. |
Abraxane |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom |
EU/1/07/428 |
2.3.2015. |
|
26.2.2015. |
Bosulif |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/13/818 |
2.3.2015. |
|
26.2.2015. |
Brimica Genuair |
Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España |
EU/1/14/963 |
2.3.2015. |
|
26.2.2015. |
Duaklir Genuair |
Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España |
EU/1/14/964 |
2.3.2015. |
|
26.2.2015. |
Epivir |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/96/015 |
2.3.2015. |
|
26.2.2015. |
Lysodren |
Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France |
EU/1/04/273 |
2.3.2015. |
|
26.2.2015. |
Prevenar 13 |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/09/590 |
2.3.2015. |
|
26.2.2015. |
Yellox |
PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika |
EU/1/11/692 |
2.3.2015. |
|
26.2.2015. |
Ziagen |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/99/112 |
2.3.2015. |
— 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 |
|
11.2.2015. |
Pumarix |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/10/664 |
13.2.2015. |
— Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. 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 |
|
6.2.2015. |
Zulvac SBV |
Inaktivēts Šmalenbergas vīruss, celms BH80/11-4 |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/14/178 |
Suspensija injekcijai |
QI02AA |
10.2.2015. |
— Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas
|
Lēmuma datums |
Zāļu nosaukums |
Tirdzniecības atļaujas turētājs |
Ieraksta numurs Kopienas reģistrā |
Paziņojuma datums |
|
17.2.2015. |
BTVPUR AlSap 1 |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/10/112 |
19.2.2015. |
|
17.2.2015. |
BTVPUR AlSap 1-8 |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/10/113 |
19.2.2015. |
|
19.2.2015. |
Nobivac Myxo-RHD |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/11/132 |
23.2.2015. |
|
26.2.2015. |
CERTIFECT |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/11/125 |
2.3.2015. |
|
26.2.2015. |
ECOPORC SHIGA |
IDT Biologika GmbH Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland |
EU/2/13/149 |
2.3.2015. |
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.