|
30.12.2016 |
RO |
Jurnalul Oficial al Uniunii Europene |
C 490/1 |
Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 noiembrie 2016 până la 30 noiembrie 2016
[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului (1)]
(2016/C 490/01)
— Emiterea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat
|
Data deciziei |
Denumirea medicamentului |
DCI (Denumirea Comună Internațională) |
Titularul autorizației de introducere pe piață |
Numărul de înregistrare în Registrul comunitar |
Formă farmaceutică |
Codul ATC (Codul Anatomic-Terapeutic-Chimic) |
Data notificării |
|
9.11.2016 |
Emtricitabine/Tenofovir disoproxil Zentiva |
emtricitabină/tenofovir disoproxil |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/16/1148 |
Comprimat filmat |
J05AR03 |
11.11.2016 |
|
9.11.2016 |
IBRANCE |
palbociclib |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/16/1147 |
Capsule |
L01XE33 |
11.11.2016 |
|
9.11.2016 |
Lartruvo |
olaratumabum |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/16/1143 |
Concentrat pentru soluție perfuzabilă |
L01XC27 |
11.11.2016 |
|
11.11.2016 |
Glyxambi |
empagliflozin/linagliptin |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/16/1146 |
Comprimat filmat |
A10BD19 |
15.11.2016 |
|
11.11.2016 |
Ivabradine JensonR |
ivabradină |
JensonR+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 UD, United Kingdom |
EU/1/16/1145 |
Comprimat filmat |
C01EB17 |
15.11.2016 |
|
11.11.2016 |
Ivabradine Zentiva |
ivabradină |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/16/1144 |
Comprimat filmat |
C01EB17 |
15.11.2016 |
|
11.11.2016 |
Parsabiv |
etelcalcetidă |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/16/1142 |
Soluție injectabilă |
H05BX04 |
15.11.2016 |
|
11.11.2016 |
XALKORI |
crizotinib |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/12/793 |
Capsule |
L01XE16 |
15.11.2016 |
|
14.11.2016 |
Erivedge |
vismodegib |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/13/848 |
Capsule |
L01XX43 |
16.11.2016 |
|
14.11.2016 |
Granpidam |
sildenafil |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/16/1137 |
Comprimat filmat |
G04BE03 |
16.11.2016 |
|
21.11.2016 |
Ninlaro |
ixazomib |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/16/1094 |
Capsule |
L01XX50 |
23.11.2016 |
— Modificarea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat
|
Data deciziei |
Denumirea medicamentului |
Titularul autorizației de introducere pe piață |
Numărul de înregistrare în Registrul comunitar |
Data notificării |
|
3.11.2016 |
Daliresp |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/11/668 |
7.11.2016 |
|
3.11.2016 |
Emtriva |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/03/261 |
7.11.2016 |
|
3.11.2016 |
Intanza |
Sanofi Pasteur Europe 2 Avenue Pont Pasteur, 69007 Lyon, France |
EU/1/08/505 |
7.11.2016 |
|
3.11.2016 |
Libertek |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/11/666 |
7.11.2016 |
|
3.11.2016 |
Vibativ |
Theravance Biopharma Ireland Limited Fitzwilliam Hall, Fitzwilliam Place, Dublin 2, Ireland |
EU/1/11/705 |
7.11.2016 |
|
9.11.2016 |
Iclusig |
Incyte Biosciences UK Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom |
EU/1/13/839 |
11.11.2016 |
|
9.11.2016 |
Lyrica |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/04/279 |
11.11.2016 |
|
9.11.2016 |
Sutent |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/347 |
11.11.2016 |
|
9.11.2016 |
Zytiga |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/11/714 |
14.11.2016 |
|
11.11.2016 |
Abraxane |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom |
EU/1/07/428 |
15.11.2016 |
|
11.11.2016 |
Desloratadină Actavis |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |
EU/1/11/745 |
15.11.2016 |
|
11.11.2016 |
Erivedge |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/13/848 |
15.11.2016 |
|
11.11.2016 |
Foscan |
biolitec Pharma Ltd.. Otto-Schott-Str. 15, 07745 Jena, Deutschland |
EU/1/01/197 |
15.11.2016 |
|
11.11.2016 |
Glidipion |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |
EU/1/12/756 |
15.11.2016 |
|
11.11.2016 |
Hexyon |
Sanofi Pasteur Europe 2 Avenue Pont Pasteur, 69007 Lyon, France |
EU/1/13/829 |
15.11.2016 |
|
11.11.2016 |
Incruse |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/922 |
15.11.2016 |
|
11.11.2016 |
Keppra |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/00/146 |
15.11.2016 |
|
11.11.2016 |
Lojuxta |
Aegerion Pharmaceuticals Limited Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom |
EU/1/13/851 |
15.11.2016 |
|
11.11.2016 |
Lucentis |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/374 |
15.11.2016 |
|
11.11.2016 |
Mirvaso |
Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France |
EU/1/13/904 |
15.11.2016 |
|
11.11.2016 |
Neuraceq |
Piramal Imaging Limited Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom |
EU/1/13/906 |
15.11.2016 |
|
11.11.2016 |
Picato |
Leo Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark |
EU/1/12/796 |
15.11.2016 |
|
11.11.2016 |
Pioglitazonă Actavis |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |
EU/1/12/755 |
15.11.2016 |
|
11.11.2016 |
Pregabalin Pfizer |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/14/916 |
15.11.2016 |
|
11.11.2016 |
Stelara |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/08/494 |
15.11.2016 |
|
11.11.2016 |
Strensiq |
Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France |
EU/1/15/1015 |
15.11.2016 |
|
11.11.2016 |
Taxespira |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom |
EU/1/15/1017 |
15.11.2016 |
|
11.11.2016 |
Teysuno |
Nordic Group B.V. Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland |
EU/1/11/669 |
15.11.2016 |
|
11.11.2016 |
Translarna |
PTC Therapeutics International Limited 77 Sir John Rogerson’s Quay, Dublin 2, Ireland |
EU/1/13/902 |
15.11.2016 |
|
14.11.2016 |
Bretaris Genuair |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/12/781 |
16.11.2016 |
|
14.11.2016 |
Clopidogrel ratiopharm |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/14/975 |
16.11.2016 |
|
14.11.2016 |
Duloxetine Zentiva |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/15/1028 |
16.11.2016 |
|
14.11.2016 |
Edarbi |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/11/734 |
16.11.2016 |
|
14.11.2016 |
Eklira Genuair |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/12/778 |
16.11.2016 |
|
14.11.2016 |
Esmya |
Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország |
EU/1/12/750 |
16.11.2016 |
|
14.11.2016 |
Giotrif |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/13/879 |
16.11.2016 |
|
14.11.2016 |
Iasibon |
Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
EU/1/10/659 |
16.11.2016 |
|
14.11.2016 |
Isentress |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/436 |
16.11.2016 |
|
14.11.2016 |
Levetiracetam SUN |
Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland |
EU/1/11/741 |
16.11.2016 |
|
14.11.2016 |
Lucentis |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/374 |
16.11.2016 |
|
14.11.2016 |
Numient |
Impax Laboratories Ireland Limited, 56 Fitzwilliam Square, Dublin 2, Ireland |
EU/1/15/1044 |
16.11.2016 |
|
14.11.2016 |
Pioglitazonă Actavis |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |
EU/1/12/755 |
17.11.2016 |
|
14.11.2016 |
Pioglitazone Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/757 |
16.11.2016 |
|
14.11.2016 |
Praluent |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/15/1031 |
16.11.2016 |
|
14.11.2016 |
Ribavirin Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/509 |
16.11.2016 |
|
14.11.2016 |
Ribavirin Teva Pharma BV |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/527 |
16.11.2016 |
|
14.11.2016 |
Topotecan Hospira |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom |
EU/1/10/633 |
16.11.2016 |
|
14.11.2016 |
Trisenox |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/02/204 |
16.11.2016 |
|
14.11.2016 |
Triumeq |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/14/940 |
16.11.2016 |
|
18.11.2016 |
Daxas |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/10/636 |
22.11.2016 |
|
18.11.2016 |
Jakavi |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/773 |
22.11.2016 |
|
18.11.2016 |
Pioglitazone Teva Pharma |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/758 |
22.11.2016 |
|
18.11.2016 |
Procysbi |
Raptor Pharmaceuticals Europe BV Naritaweg 165, NL-1043 BW Amsterdam, Nederland |
EU/1/13/861 |
22.12.2016 |
|
18.11.2016 |
Selincro |
H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark |
EU/1/12/815 |
22.11.2016 |
|
18.11.2016 |
Signifor |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/753 |
22.11.2016 |
|
18.11.2016 |
Thymanax |
Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland |
EU/1/08/498 |
22.11.2016 |
|
18.11.2016 |
Valdoxan |
Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes Cedex, France |
EU/1/08/499 |
22.11.2016 |
|
18.11.2016 |
Xaluprine |
Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom |
EU/1/11/727 |
22.11.2016 |
|
21.11.2016 |
Ameluz |
Biofrontera Bioscience GmbH Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland |
EU/1/11/740 |
23.11.2016 |
|
21.11.2016 |
Bemfola |
Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország |
EU/1/13/909 |
23.11.2016 |
|
21.11.2016 |
Cystadane |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F- 92 800 Puteaux, France |
EU/1/06/379 |
23.11.2016 |
|
21.11.2016 |
Elonva |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/09/609 |
23.11.2016 |
|
21.11.2016 |
Opdivo |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/15/1014 |
23.11.2016 |
|
29.11.2016 |
Ammonaps |
Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige |
EU/1/99/120 |
1.12.2016 |
|
29.11.2016 |
PANTOLOC Control |
Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
EU/1/09/519 |
1.12.2016 |
— Retragerea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]
|
Data deciziei |
Denumirea medicamentului |
Titularul autorizației de introducere pe piață |
Numărul de înregistrare în Registrul comunitar |
Data notificării |
|
3.11.2016 |
Vitekta |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/13/883 |
7.11.2016 |
|
21.11.2016 |
Celvapan |
Nanotherapeutics Bohumil, s.r.o. Bohumil 138, 28163 Jevany, Česká republika |
EU/1/08/506 |
23.11.2016 |
— Modificarea unei autorizații de introducere pe piață (articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului): Acceptat
|
Data deciziei |
Denumirea medicamentului |
Titularul autorizației de introducere pe piață |
Numărul de înregistrare în Registrul comunitar |
Data notificării |
|
3.11.2016 |
Fungitraxx |
Avimedical B.V. Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland |
EU/2/13/160 |
7.11.2016 |
|
9.11.2016 |
Draxxin |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/03/041 |
14.11.2016 |
|
9.11.2016 |
Inflacam |
Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland |
EU/2/11/134 |
11.11.2016 |
|
9.11.2016 |
Semintra |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/12/146 |
11.11.2016 |
|
11.11.2016 |
Sileo |
Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi |
EU/2/15/181 |
15.11.2016 |
|
29.11.2016 |
BROADLINE |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/13/157 |
1.12.2016 |
Oricine este interesat să consulte raportul public de evaluare al medicamentului în cauză și deciziile aferente este invitat să contacteze:
|
European Medicines Agency |
|
30 Churchill Place |
|
Canary Wharf |
|
London E14 5EU |
|
United Kingdom |
(1) JO L 136, 30.4.2004, p. 1.