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25.9.2015 |
HR |
Službeni list Europske unije |
C 318/1 |
Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2015. do 31. kolovoza 2015.
(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))
(2015/C 318/01)
— Izdavanje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno
|
Datum odluke |
Naziv lijeka |
INN (međunarodni nezaštićeni naziv lijeka) |
Nositelj odobrenja za stavljanje u promet |
Broj upisa u registar Zajednice |
Farmaceutski oblik |
Oznaka ATC (Anatomsko-terapijsko-kemijska klasifikacija lijekova) |
Datum obavijesti |
|
14.8.2015. |
Odomzo |
sonidegib |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/1030 |
Kapsula, tvrda |
L01XX48 |
18.8.2015. |
|
14.8.2015. |
Unituxin |
dinutuksimaba |
United Therapeutics Europe Ltd Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom |
EU/1/15/1022 |
Koncentrat za otopinu za infuziju |
L01XC16 |
18.8.2015. |
|
20.8.2015. |
Aripiprazole Sandoz |
Aripiprazol |
Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich |
EU/1/15/1029 |
Tableta |
N05AX12 |
24.8.2015. |
|
20.8.2015. |
Duloxetine Zentiva |
duloksetin |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/15/1028 |
Želučanootporna tvrda kapsula |
N06AX21 |
25.8.2015. |
|
20.8.2015. |
Respreeza |
ljudski inhibitor alfa1-proteinaze |
CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/15/1006 |
Prašak i otapalo za otopinu za infuziju |
B02AB02 |
25.8.2015. |
|
28.8.2015. |
Docetaxel Hospira UK Limited |
docetaksel |
Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
EU/1/15/1017 |
Koncentrat za otopinu za infuziju |
L01CD02 |
1.9.2015. |
|
28.8.2015. |
Farydak |
panobinostat |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/1023 |
Kapsula, tvrda |
L01XX42 |
1.9.2015. |
|
28.8.2015. |
Kanuma |
sebelipaza alfa |
Synageva BioPharma Ltd 1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom |
EU/1/15/1033 |
Koncentrat za otopinu za infuziju |
Pending |
1.9.2015. |
|
28.8.2015. |
Pregabalin Accord |
pregabalin |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/15/1027 |
Kapsula, tvrda |
N03AX16 |
1.9.2015. |
|
28.8.2015. |
Strensiq |
asfotaze alfa |
Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France |
EU/1/15/1015 |
Otopina za injekciju |
Pending |
1.9.2015. |
— 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 |
|
6.8.2015. |
Aerius |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/00/160 |
10.8.2015. |
|
6.8.2015. |
Azomyr |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/00/157 |
10.8.2015. |
|
6.8.2015. |
IDflu |
Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France |
EU/1/08/507 |
10.8.2015. |
|
6.8.2015. |
Intanza |
Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/08/505 |
10.8.2015. |
|
12.8.2015. |
Cyanokit |
SERB S.A. Avenue Louise 480, 1050 Brussels, Belgique |
EU/1/07/420 |
14.8.2015. |
|
12.8.2015. |
Retacrit |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom |
EU/1/07/431 |
14.8.2015. |
|
14.8.2015. |
Cialis |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/02/237 |
18.8.2015. |
|
14.8.2015. |
Komboglyze |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/11/731 |
18.8.2015. |
|
14.8.2015. |
Norvir |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/96/016 |
18.8.2015. |
|
20.8.2015. |
Adcirca |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/08/476 |
24.8.2015. |
|
20.8.2015. |
BeneFIX |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/97/047 |
24.8.2015. |
|
20.8.2015. |
Eliquis |
Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |
EU/1/11/691 |
24.8.2015. |
|
20.8.2015. |
Entyvio |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/14/923 |
24.8.2015. |
|
20.8.2015. |
Eporatio |
ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/09/573 |
24.8.2015. |
|
20.8.2015. |
Fareston |
Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi |
EU/1/96/004 |
24.8.2015. |
|
20.8.2015. |
Infanrix hexa |
GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique |
EU/1/00/152 |
1.9.2015. |
|
20.8.2015. |
Invokana |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/13/884 |
24.8.2015. |
|
20.8.2015. |
Kalydeco |
Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom |
EU/1/12/782 |
27.8.2015. |
|
20.8.2015. |
Keppra |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/00/146 |
24.8.2015. |
|
20.8.2015. |
OLYSIO |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/14/924 |
24.8.2015. |
|
20.8.2015. |
Qutenza |
Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EU/1/09/524 |
24.8.2015. |
|
20.8.2015. |
Stayveer |
Marklas Nederland B.V. Beneluxlaan 2b, NL-3446 GR Woerden, Nederland |
EU/1/13/832 |
24.8.2015. |
|
20.8.2015. |
Tracleer |
Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/02/220 |
24.8.2015. |
|
20.8.2015. |
Twynsta |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/10/648 |
24.8.2015. |
|
20.8.2015. |
Vokanamet |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/14/918 |
24.8.2015. |
|
25.8.2015. |
Adasuve |
Ferrer Internacional S.A. Gran Via Carlos III, 94 08028 Barcelona Spain |
EU/1/13/823 |
27.8.2015. |
|
25.8.2015. |
Biopoin |
Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/09/565 |
27.8.2015. |
|
25.8.2015. |
IDflu |
Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France |
EU/1/08/507 |
27.8.2015. |
|
25.8.2015. |
Intanza |
Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/08/505 |
27.8.2015. |
|
25.8.2015. |
Mekinist |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/14/931 |
27.8.2015. |
|
25.8.2015. |
Optaflu |
Novartis Influenza Vaccines Marburg GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/07/394 |
27.8.2015. |
|
25.8.2015. |
Revolade |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/612 |
27.8.2015. |
|
25.8.2015. |
Tafinlar |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/13/865 |
27.8.2015. |
|
25.8.2015. |
Temozolomide Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/09/606 |
27.8.2015. |
|
25.8.2015. |
Zykadia |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/999 |
27.8.2015. |
|
28.8.2015. |
Fluenz Tetra |
MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland |
EU/1/13/887 |
1.9.2015. |
— 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 |
|
28.8.2015. |
Porcilis PCV ID |
Svinjski cirkovirus tip 2, ORF2 subjedinični antigen |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/15/187 |
Emulzija za injekciju |
QI09AA07 |
1.9.2015. |
— 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 |
|
6.8.2015. |
Advocate |
Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland |
EU/2/03/039 |
10.8.2015. |
|
20.8.2015. |
Eurican Herpes 205 |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/01/029 |
24.8.2015. |
|
28.8.2015. |
Equilis StrepE |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/04/043 |
1.9.2015. |
|
28.8.2015. |
Fevaxyn Pentofel |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/96/002 |
1.9.2015. |
Zainteresirane osobe koje žele na uvid dobiti javno izvješće o procjeni predmetnih lijekova i odluka koje se na njih odnose trebale bi se obratiti:
|
The European Medicines Agency |
|
7, Westferry Circus, Canary Wharf |
|
UK – LONDON E14 4H |
(1) SL L 136, 30.4.2004., str. 1.