23.2.2018 |
HR |
Službeni list Europske unije |
C 70/1 |
Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2018. do 31. siječnja 2018.
(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))
(2018/C 070/01)
— |
Izdavanje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
Datum odluke |
Naziv lijeka |
INN (medunarodni nezašticeni naziv lijeka) |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Farmaceutski oblik |
Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) |
Datum obavijesti |
8.1.2018. |
ADYNOVI |
rurioktokog alfa pegol |
Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich |
EU/1/17/1247 |
Prašak i otapalo za otopinu za injekciju |
B02BD02 |
10.1.2018. |
8.1.2018. |
Fasenra |
benralizumab |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/17/1252 |
Otopina za injekciju |
R03DX10 |
10.1.2018. |
8.1.2018. |
Fulvestrant Mylan |
fulvestranta |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/17/1253 |
Otopina za injekciju |
L02BA03 |
10.1.2018. |
8.1.2018. |
Intrarosa |
prasteron |
Endoceutics Ltd. Salisbury house, London Wall, London, EC2M 5PS, United Kingdom |
EU/1/17/1255 |
Pesar |
QM01AX92 |
6.2.2018. |
8.1.2018. |
Jorveza |
budezonid |
Dr Falk Pharma GmbH Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland |
EU/1/17/1254 |
Raspadljiva tableta za usta |
A07EA06 |
10.1.2018. |
8.1.2018. |
Ocrevus |
okrelizumab |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/17/1231 |
Koncentrat za otopinu za infuziju |
L04AA36 |
10.1.2018. |
8.1.2018. |
PREVYMIS |
letermovir |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/17/1245 |
Filmom obložena tableta Koncentrat za otopinu za infuziju |
J05AX18 |
10.1.2018. |
15.1.2018. |
Mvasi |
bevacizumab |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/17/1246 |
Koncentrat za otopinu za infuziju |
L01XC07 |
17.1.2018. |
18.1.2018. |
Darunavir Krka d.d. |
darunavir |
Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/17/1248 |
Filmom obložena tableta |
J05AE10 |
22.1.2018. |
26.1.2018. |
Darunavir Krka |
darunavir |
Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/17/1249 |
Filmom obložena tableta |
J05AE10 |
30.1.2018. |
— |
Izdavanje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Odbijeno |
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
8.1.2018. |
Onzeald |
Nektar Therapeutics UK Limited Elizabeth House, 13-19 Queen Street, Leeds LS1 2TW, United Kingdom |
— |
10.1.2018. |
15.1.2018. |
Fanaptum |
Vanda Pharmaceuticals Limited 222 Regent Street, London W1B 5TR, United Kingdom |
— |
19.1.2018. |
— |
Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
8.1.2018. |
Bronchitol |
Pharmaxis Pharmaceuticals Limited 25 Moorgate, London, EC2R 6AY, United Kingdom |
EU/1/12/760 |
10.1.2018. |
8.1.2018. |
Cimzia |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/09/544 |
10.1.2018. |
8.1.2018. |
Cometriq |
Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |
EU/1/13/890 |
10.1.2018. |
8.1.2018. |
Comtess |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi |
EU/1/98/082 |
10.1.2018. |
8.1.2018. |
Hexacima |
Sanofi Pasteur SA 2 avenue Pont Pasteur, 69007 Lyon, France |
EU/1/13/828 |
10.1.2018. |
8.1.2018. |
Hexyon |
Sanofi Pasteur Europe 2 avenue Pont Pasteur, 69007 Lyon, France |
EU/1/13/829 |
10.1.2018. |
8.1.2018. |
HyQvia |
Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich |
EU/1/13/840 |
10.1.2018. |
8.1.2018. |
Imatinib Actavis |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |
EU/1/13/825 |
10.1.2018. |
8.1.2018. |
Ixiaro |
Valneva Austria GmbH Campus Vienna Biocenter 3, 1030 Wien, Österreich |
EU/1/08/501 |
10.1.2018. |
8.1.2018. |
Jardiance |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/14/930 |
10.1.2018. |
8.1.2018. |
Memantine LEK |
Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
EU/1/13/826 |
10.1.2018. |
8.1.2018. |
Memantine Mylan |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/13/827 |
15.1.2018. |
8.1.2018. |
Nemdatine |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |
EU/1/13/824 |
10.1.2018. |
8.1.2018. |
Orkambi |
Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom |
EU/1/15/1059 |
10.1.2018. |
8.1.2018. |
Pradaxa |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/08/442 |
10.1.2018. |
8.1.2018. |
Stayveer |
Marklas Nederland B.V. Beneluxlaan 2b, 3446 GR Woerden, Nederland |
EU/1/13/832 |
10.1.2018. |
8.1.2018. |
Synjardy |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/15/1003 |
10.1.2018. |
8.1.2018. |
Tolucombi |
Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/13/821 |
10.1.2018. |
8.1.2018. |
Votrient |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/628 |
10.1.2018. |
8.1.2018. |
Yervoy |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/11/698 |
10.1.2018. |
8.1.2018. |
Zinbryta |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/16/1107 |
10.1.2018. |
8.1.2018. |
Zonegran |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/04/307 |
10.1.2018. |
11.1.2018. |
Carbaglu |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France |
EU/1/02/246 |
15.1.2018. |
11.1.2018. |
Cinacalcet Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/15/1054 |
15.1.2018. |
11.1.2018. |
Cystadrops |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France |
EU/1/15/1049 |
15.1.2018. |
11.1.2018. |
Cystagon |
Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France |
EU/1/97/039 |
15.1.2018. |
11.1.2018. |
Lartruvo |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/16/1143 |
15.1.2018. |
11.1.2018. |
Laventair |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/899 |
15.1.2018. |
11.1.2018. |
Levetiracetam Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/11/701 |
15.1.2018. |
11.1.2018. |
OLYSIO |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/924 |
15.1.2018. |
15.1.2018. |
Adasuve |
Ferrer Internacional S.A. Gran Via Carlos III, 94 08028 Barcelona, España |
EU/1/13/823 |
17.1.2018. |
15.1.2018. |
Ciambra |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg |
EU/1/15/1055 |
17.1.2018. |
15.1.2018. |
Prialt |
Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/04/302 |
17.1.2018. |
15.1.2018. |
Zostavax |
MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/06/341 |
17.1.2018. |
18.1.2018. |
Bortezomib Hospira |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom |
EU/1/16/1114 |
22.1.2018. |
18.1.2018. |
Leganto |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/11/695 |
22.1.2018. |
18.1.2018. |
Marixino |
Consilient Health Ltd 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland |
EU/1/13/820 |
22.1.2018. |
18.1.2018. |
Omidria |
Omeros London Limited Berkeley Square, London, W1J 6BD, United Kingdom |
EU/1/15/1018 |
22.1.2018. |
18.1.2018. |
Taltz |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/15/1085 |
22.1.2018. |
18.1.2018. |
Tenofovir disoproxil Zentiva |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/16/1127 |
22.1.2018. |
18.1.2018. |
XALKORI |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/12/793 |
22.1.2018. |
18.1.2018. |
Yervoy |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/11/698 |
22.1.2018. |
24.1.2018. |
Cervarix |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/07/419 |
26.1.2018. |
24.1.2018. |
DUAVIVE |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/14/960 |
26.1.2018. |
24.1.2018. |
IBRANCE |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/16/1147 |
26.1.2018. |
24.1.2018. |
LeukoScan |
Immunomedics GmbH Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland |
EU/1/97/032 |
26.1.2018. |
25.1.2018. |
Matever |
Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
EU/1/11/711 |
29.1.2018. |
26.1.2018. |
Cerdelga |
Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland |
EU/1/14/974 |
30.1.2018. |
26.1.2018. |
Mysimba |
Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland |
EU/1/14/988 |
30.1.2018. |
30.1.2018. |
Cialis |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/02/237 |
31.1.2018. |
30.1.2018. |
Colobreathe |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/11/747 |
1.2.2018. |
30.1.2018. |
Copalia |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/372 |
1.2.2018. |
30.1.2018. |
Copalia HCT |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/575 |
1.2.2018. |
30.1.2018. |
Cresemba |
Basilea Medical Ltd c/o Cox Costello & Horne Limited, Langwood House, 63-81 High Street, Rickmansworth, Hertfordshire WD3 1EQ, United Kingdom |
EU/1/15/1036 |
1.2.2018. |
30.1.2018. |
Dafiro |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/371 |
1.2.2018. |
30.1.2018. |
Dafiro HCT |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/574 |
1.2.2018. |
30.1.2018. |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/17/1222 |
1.2.2018. |
30.1.2018. |
Effentora |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/08/441 |
1.2.2018. |
30.1.2018. |
Exforge HCT |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/569 |
1.2.2018. |
30.1.2018. |
Fycompa |
Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom |
EU/1/12/776 |
1.2.2018. |
30.1.2018. |
Granpidam |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/16/1137 |
1.2.2018. |
30.1.2018. |
Hizentra |
CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland |
EU/1/11/687 |
1.2.2018. |
30.1.2018. |
Ivemend |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/437 |
1.2.2018. |
30.1.2018. |
Nplate |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/08/497 |
1.2.2018. |
30.1.2018. |
Rotarix |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/05/330 |
1.2.2018. |
30.1.2018. |
Stelara |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/08/494 |
2.2.2018. |
30.1.2018. |
Vectibix |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/07/423 |
1.2.2018. |
— |
Povlačenje odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) |
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
11.1.2018. |
Daliresp |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/11/668 |
15.1.2018. |
11.1.2018. |
Insulin Human Winthrop |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/06/368 |
15.1.2018. |
11.1.2018. |
Libertek |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/11/666 |
15.1.2018. |
18.1.2018. |
Zoledronic acid Teva Pharma |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/772 |
22.1.2018. |
30.1.2018. |
LeukoScan |
Immunomedics GmbH Paul-Ehrlich-Straße 22/D1, 63322 Rödermark, Deutschland |
EU/1/97/032 |
1.2.2018. |
— |
Izdavanje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
Datum odluke |
Naziv lijeka |
INN (medunarodni nezašticeni naziv lijeka) |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Farmaceutski oblik |
Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) |
Datum obavijesti |
9.1.2018. |
GALLIPRANT |
grapiprant |
Aratana Therapeutics NV Ambachtenlaan 1, 3001 Heverlee, België |
EU/2/17/221 |
Tableta |
QM01AX92 |
11.1.2018. |
31.1.2018. |
MiPet Easecto |
sarolaner |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/17/220 |
Tablete za žvakanje |
QP53BE03 |
2.2.2018. |
— |
Izmjena odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
Datum odluke |
Naziv lijeka |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Datum obavijesti |
9.1.2018. |
Cortavance |
VIRBAC S.A. 1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France |
EU/2/06/069 |
11.1.2018. |
9.1.2018. |
Ypozane |
VIRBAC S.A. 1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France |
EU/2/06/068 |
11.1.2018. |
12.1.2018. |
Aftovaxpur Doe |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
EU/2/13/153 |
16.1.2018. |
12.1.2018. |
Leucofeligen FeLV/RCP |
Virbac 1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France |
EU/2/09/097 |
16.1.2018. |
12.1.2018. |
Virbagen Omega |
VIRBAC S.A. 1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France |
EU/2/01/030 |
16.1.2018. |
12.1.2018. |
Zactran |
Merial 29 avenue Tony Garnier, 69007 Lyon, France |
EU/2/08/082 |
16.1.2018. |
16.1.2018. |
Semintra |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/12/146 |
18.1.2018. |
31.1.2018. |
Meloxoral |
Le Vet B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland |
EU/2/10/111 |
2.2.2018. |
Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:
European Medicines Agency |
30 Churchill Place |
Canary Wharf |
London E14 5EU |
United Kingdom |
(1) SL L 136, 30.4.2004, str. 1.