ISSN 1977-1088
Službeni list
Europske unije
C 208
Hrvatsko izdanje
Informacije i objave
Godište 60.
30. lipnja 2017.
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ISSN 1977-1088 |
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Službeni list Europske unije |
C 208 |
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Hrvatsko izdanje |
Informacije i objave |
Godište 60. |
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Obavijest br. |
Sadržaj |
Stranica |
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IV. Obavijesti |
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OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
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Europska komisija |
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2017/C 208/01 |
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2017/C 208/02 |
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HR |
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IV. Obavijesti
OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE
Europska komisija
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30.6.2017 |
HR |
Službeni list Europske unije |
C 208/1 |
Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2017. do 31. svibnja 2017.
(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))
(2017/C 208/01)
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— |
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 |
|
8.5.2017. |
Dinutuximab beta Apeiron |
dinutuksimab beta |
APEIRON Biologics AG Campus Vienna Biocenter 5, A-1030 Wien, Österreich |
EU/1/17/1191 |
Koncentrat za otopinu za infuziju |
L01XC |
11.5.2017. |
|
22.5.2017. |
Axumin |
fluciklovin (18F) |
Blue Earth Diagnostics Ltd 215 Euston Road, London NW1 2BE, United Kingdom |
EU/1/17/1186 |
Otopina za injekciju |
V09IX12 |
24.5.2017. |
|
22.5.2017. |
Fampyra |
fampridin |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/11/699 |
Tablete s produženim oslobađanjem |
N07XX07 |
24.5.2017. |
|
22.5.2017. |
Ivabradin Accord |
ivabradin |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/17/1190 |
Filmom obložena tableta |
C01EB17 |
24.5.2017. |
|
24.5.2017. |
Trumenba |
Cjepivo protiv meningokoka grupe B (rekombinirano, adsorbirano) |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/17/1187 |
Suspenzija za injekciju |
J07AH09 |
30.5.2017. |
|
30.5.2017. |
Brineura |
cerliponaze alfa |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland |
EU/1/17/1192 |
Otopina za infuziju |
A16AB |
1.6.2017. |
|
30.5.2017. |
Spinraza |
nusinersen |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/17/1188 |
Otopina za injekciju |
Pending |
1.6.2017. |
|
— |
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 |
|
2.5.2017. |
Adempas |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/13/907 |
4.5.2017. |
|
2.5.2017. |
Emtricitabine/Tenofovir disoproxil Krka |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/16/1151 |
4.5.2017. |
|
2.5.2017. |
KEYTRUDA |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/15/1024 |
4.5.2017. |
|
2.5.2017. |
Prolia |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/10/618 |
4.5.2017. |
|
2.5.2017. |
Xenical |
CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24, 17489 Greifswald, Deutschland |
EU/1/98/071 |
4.5.2017. |
|
4.5.2017. |
Ebymect |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/15/1051 |
8.5.2017. |
|
4.5.2017. |
Imatinib Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/845 |
8.5.2017. |
|
4.5.2017. |
Qutenza |
Grünenthal GmbH Zieglerstrasse 6, D-52078, Aachen, Deutschland |
EU/1/09/524 |
8.5.2017. |
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8.5.2017. |
Akynzeo |
Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland |
EU/1/15/1001 |
11.5.2017. |
|
8.5.2017. |
Glivec |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/01/198 |
11.5.2017. |
|
8.5.2017. |
Ivabradine Anpharm |
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. ul. Annopol 6B, 03–236 Warszawa, Polska |
EU/1/15/1041 |
11.5.2017. |
|
8.5.2017. |
Pergoveris |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/07/396 |
11.5.2017. |
|
8.5.2017. |
Rasagiline Mylan |
Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France |
EU/1/16/1090 |
11.5.2017. |
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8.5.2017. |
Simbrinza |
Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
EU/1/14/933 |
11.5.2017. |
|
8.5.2017. |
Xarelto |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/08/472 |
11.5.2017. |
|
16.5.2017. |
Azarga |
Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
EU/1/08/482 |
18.5.2017. |
|
16.5.2017. |
DuoTrav |
Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
EU/1/06/338 |
18.5.2017. |
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16.5.2017. |
Emadine |
Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
EU/1/98/095 |
18.5.2017. |
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16.5.2017. |
Feraccru |
Shield TX (UK) Limited Gateshead Quays, NE8 3DF, United Kingdom |
EU/1/15/1075 |
18.5.2017. |
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16.5.2017. |
Lysodren |
Laboratoire HRA Pharma 15 rue Béranger, F-75003 Pariz, France |
EU/1/04/273 |
18.5.2017. |
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16.5.2017. |
Mabthera |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/98/067 |
18.5.2017. |
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16.5.2017. |
Marixino |
Consilient Health Ltd 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland |
EU/1/13/820 |
18.5.2017. |
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16.5.2017. |
Nevanac |
Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
EU/1/07/433 |
18.5.2017. |
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16.5.2017. |
Obizur |
Baxalta Innovations GmbH Industriestrasse 67, A-1221 Wien, Österreich |
EU/1/15/1035 |
18.5.2017. |
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16.5.2017. |
Tygacil |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/06/336 |
18.5.2017. |
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18.5.2017. |
Brilique |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/10/655 |
23.5.2017. |
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18.5.2017. |
Desloratadine Actavis |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |
EU/1/11/745 |
23.5.2017. |
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18.5.2017. |
Desloratadine ratiopharm |
ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/11/746 |
23.5.2017. |
|
18.5.2017. |
Fampyra |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/11/699 |
23.5.2017. |
|
18.5.2017. |
Ratiograstim |
ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/08/444 |
23.5.2017. |
|
18.5.2017. |
Taxotere |
Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France |
EU/1/95/002 |
23.5.2017. |
|
18.5.2017. |
Zalasta |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/07/415 |
22.5.2017. |
|
18.5.2017. |
Zelboraf |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/12/751 |
23.5.2017. |
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22.5.2017. |
Aerinaze |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/399 |
24.5.2017. |
|
22.5.2017. |
Clopidogrel BGR |
Laboratoires BIOGARAN 15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France |
EU/1/09/558 |
24.5.2017. |
|
22.5.2017. |
Dacogen |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/12/792 |
24.5.2017. |
|
22.5.2017. |
Faslodex |
AstraZeneca UK Limited Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom |
EU/1/03/269 |
24.5.2017. |
|
22.5.2017. |
Inlyta |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/12/777 |
24.5.2017. |
|
22.5.2017. |
IntronA |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/99/127 |
24.5.2017. |
|
22.5.2017. |
PHEBURANE |
Lucane Pharma 172 rue de Charonne, 75011 Pariz, France |
EU/1/13/822 |
24.5.2017. |
|
22.5.2017. |
Rasilez |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/405 |
24.5.2017. |
|
22.5.2017. |
Respreeza |
CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/15/1006 |
24.5.2017. |
|
22.5.2017. |
Sildenafil Actavis |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |
EU/1/09/595 |
24.5.2017. |
|
22.5.2017. |
Tasigna |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/422 |
24.5.2017. |
|
22.5.2017. |
Temozolomide Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/10/615 |
24.5.2017. |
|
22.5.2017. |
Zeffix |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/99/114 |
24.5.2017. |
|
22.5.2017. |
Zoledronic acid Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/771 |
24.5.2017. |
|
22.5.2017. |
Zoledronic acid Teva Pharma |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/772 |
24.5.2017. |
|
24.5.2017. |
Aerius |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/00/160 |
30.5.2017. |
|
24.5.2017. |
Azomyr |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/00/157 |
30.5.2017. |
|
24.5.2017. |
Busilvex |
Pierre Fabre Médicament 45 place Abel Gance, F-92654 Boulogne-Billancourt Cedex, France |
EU/1/03/254 |
30.5.2017. |
|
24.5.2017. |
Cotellic |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/15/1048 |
31.5.2017. |
|
24.5.2017. |
Desloratadine Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/11/732 |
30.5.2017. |
|
24.5.2017. |
Ecalta |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/07/416 |
30.5.2017. |
|
24.5.2017. |
Epivir |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/96/015 |
30.5.2017. |
|
24.5.2017. |
Fasturtec |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Pariz, France |
EU/1/00/170 |
30.5.2017. |
|
24.5.2017. |
Ferriprox |
Apotex Europe B.V. Darwinweg 20, NL-2333 CR Leiden, Nederland |
EU/1/99/108 |
30.5.2017. |
|
24.5.2017. |
Harvoni |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/14/958 |
30.5.2017. |
|
24.5.2017. |
Imnovid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/13/850 |
30.5.2017. |
|
24.5.2017. |
Kaletra |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/01/172 |
30.5.2017. |
|
24.5.2017. |
Memantine LEK |
Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
EU/1/13/826 |
31.5.2017. |
|
24.5.2017. |
Mirvaso |
Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France |
EU/1/13/904 |
30.5.2017. |
|
24.5.2017. |
Neoclarityn |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/00/161 |
30.5.2017. |
|
24.5.2017. |
NovoThirteen |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/12/775 |
30.6.2017. |
|
24.5.2017. |
Tafinlar |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/13/865 |
30.5.2017. |
|
24.5.2017. |
Tasigna |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/422 |
30.5.2017. |
|
24.5.2017. |
Zoledronic acid Mylan |
Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France |
EU/1/12/786 |
30.5.2017. |
|
31.5.2017. |
Azopt |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/00/129 |
2.6.2017. |
|
31.5.2017. |
Benepali |
Samsung Bioepis UK Limited 3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom |
EU/1/15/1074 |
2.6.2017. |
|
31.5.2017. |
Chenodeoxycholic acid Leadiant |
Leadiant GmbH Liebherrstr. 22, 80538 München, Deutschland |
EU/1/16/1110 |
2.6.2017. |
|
31.5.2017. |
Clopidogrel Apotex |
Apotex Europe B.V. Darwinweg 20, NL-2333 CR Leiden, Nederland |
EU/1/09/568 |
2.6.2017. |
|
31.5.2017. |
Elocta |
Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige |
EU/1/15/1046 |
2.6.2017. |
|
31.5.2017. |
InductOs |
Medtronic BioPharma B.V. Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland |
EU/1/02/226 |
2.6.2017. |
|
31.5.2017. |
Lopinavir/Ritonavir Mylan |
Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France |
EU/1/15/1067 |
2.6.2017. |
|
31.5.2017. |
Odomzo |
Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland |
EU/1/15/1030 |
2.6.2017. |
|
31.5.2017. |
Sycrest |
Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland |
EU/1/10/640 |
2.6.2017. |
|
31.5.2017. |
Yervoy |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/11/698 |
2.6.2017. |
|
— |
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 |
|
15.5.2017. |
Zeleris |
florfenikol/meloksikam |
Ceva Santé Animale 10 av. de La Ballastière, 33500 Libourne, France |
EU/2/17/210 |
Otopina za injekciju |
QJ01BA99 |
17.5.2017. |
|
17.5.2017. |
RESPIPORC FLUpan H1N1 |
vakcina influence svinje (inaktivirani) |
IDT Biologika GmbH Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland |
EU/2/17/209 |
Suspenzija za injekciju |
QI09AA03 |
19.5.2017. |
|
24.5.2017. |
Ingelvac PCV FLEX |
Cjepivo protiv cirkovirusa svinja (inaktivirano) |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/17/208 |
Suspenzija za injekciju |
QI09AA07 |
30.5.2017. |
|
— |
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 |
|
5.5.2017. |
Activyl |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/10/118 |
9.5.2017. |
|
5.5.2017. |
Kexxtone |
Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom |
EU/2/12/145 |
9.5.2017. |
|
5.5.2017. |
Versican Plus Pi/L4R |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/14/173 |
9.5.2017. |
|
15.5.2017. |
NEXGARD SPECTRA |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/14/177 |
17.5.2017. |
|
15.5.2017. |
Novem |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/04/042 |
17.5.2017. |
|
15.5.2017. |
Poulvac E. coli |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/12/140 |
17.5.2017. |
|
15.5.2017. |
Zactran |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/08/082 |
17.5.2017. |
|
17.5.2017. |
Suprelorin |
VIRBAC S.A. 1ère Avenue – 2065 m – L.I.D., F-06516 Carros Cedex, France |
EU/2/07/072 |
19.5.2017. |
|
17.5.2017. |
Suvaxyn Circo + MH RTU |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/15/190 |
22.5.2017. |
|
24.5.2017. |
Activyl Tick Plus |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/11/137 |
30.5.2017. |
|
24.5.2017. |
Profender |
Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland |
EU/2/05/054 |
30.5.2017. |
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.
|
30.6.2017 |
HR |
Službeni list Europske unije |
C 208/10 |
Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. svibnja 2017. do 31. svibnja 2017.
(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ (1) ili člankom 38. Direktive 2001/82/EZ (2))
(2017/C 208/02)
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— |
Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet |
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Datum odluke |
Naziv(i) lijeka |
INN (međunarodni nezaštićeni naziv lijeka) |
Nositelj(i) odobrenja za stavljanje u promet |
Država članica na koju se odnosi |
Datum obavijesti |
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5. svibnja 2017. |
Saroten and associated names |
amitriptyline |
Vidjeti Prilog |
Vidjeti Prilog |
10. svibnja 2017. |
(1) SL L 311, 28.11.2001., str. 67.
(2) SL L 311, 28.11.2001., str. 1.
PRILOG
Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene, nositelja odobrenja u državama članicama
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Država članica EU/EGP |
Nositelj odobrenja |
Zaštićeno ime |
Jačina |
Farmaceutski oblik |
Put primjene |
Sastav (koncentracija) |
|
Austrija |
Lundbeck Austria GmbH Dresdner Strasse 82 1200 Vienna Austria |
Saroten |
10 mg |
Filmom obložena tableta |
Kroz usta |
|
|
Austrija |
Lundbeck Austria GmbH Dresdner Strasse 82 1200 Vienna Austria |
Saroten |
25 mg |
Filmom obložena tableta |
Kroz usta |
|
|
Austrija |
Lundbeck Austria GmbH Dresdner Strasse 82 1200 Vienna Austria |
Saroten Retard |
25 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Austrija |
Lundbeck Austria GmbH Dresdner Strasse 82 1200 Vienna Austria |
Saroten Retard |
50 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Belgija |
Lundbeck S.A. Avenue Molière 225 1050 Brussels Belgium |
Redomex |
10 mg |
Filmom obložena tableta |
Kroz usta |
|
|
Belgija |
Lundbeck S.A. Avenue Molière 225 1050 Brussels Belgium |
Redomex |
25 mg |
Filmom obložena tableta |
Kroz usta |
|
|
Belgija |
Lundbeck S.A. Avenue Molière 225 1050 Brussels Belgium |
Redomex Diffucaps |
25 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Belgija |
Lundbeck S.A. Avenue Molière 225 1050 Brussels Belgium |
Redomex Diffucaps |
50 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Cipar |
C. G. Papaloisou Ltd. Office address: 35 Kilkis Avenue 2234 Latsia Cyprus Mail address: P.O. Box 1711 2261 Latsia Cyprus |
Saroten Retard |
25 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Cipar |
C. G. Papaloisou Ltd. Office address: 35 Kilkis Avenue 2234 Latsia Cyprus Mail address: P.O. Box 1711 2261 Latsia Cyprus |
Saroten Retard |
50 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Danska |
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark |
Saroten |
10 mg |
Filmom obložena tableta |
Kroz usta |
|
|
Danska |
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark |
Saroten |
25 mg |
Filmom obložena tableta |
Kroz usta |
|
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Danska |
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark |
Saroten Retard |
25 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Danska |
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark |
Saroten Retard |
50 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
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Estonija |
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark |
Saroten Retard |
50 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
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|
Njemačka |
Bayer Vital GmbH Medizin/Zulassung 51368 Leverkusen Germany |
Saroten Tabs |
50 mg |
Filmom obložena tableta |
Kroz usta |
|
|
Njemačka |
Bayer Vital GmbH Medizin/Zulassung 51368 Leverkusen Germany |
Saroten retard Tabs |
75 mg |
Tableta s prilagođenim oslobađanjem |
Kroz usta |
|
|
Njemačka |
Bayer Vital GmbH Medizin/Zulassung 51368 Leverkusen Germany |
Saroten 2 ml |
50 mg/2 ml |
Otopina za injekciju |
U mišić U venu |
25 mg/ml |
|
Grčka |
PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 |
SAROTEN |
25 mg |
Kapsula s prilagođenim oslobađanjem, tvrda |
Kroz usta |
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|
Grčka |
PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 |
SAROTEN |
75 mg |
Kapsula s prilagođenim oslobađanjem, tvrda |
Kroz usta |
|
|
Grčka |
PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 |
SAROTEN |
25 mg |
Obložena tableta |
Kroz usta |
|
|
Grčka |
PNG GEROLYMATOS MEDICAL AE, ASKLIPIOU 13, KRYONERI 14568 |
SAROTEN |
10 mg |
Obložena tableta |
Kroz usta |
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Luksemburg |
Lundbeck S.A. Avenue Molière 225 1050 Brussels Belgium |
Redomex |
10 mg |
Filmom obložena tableta |
Kroz usta |
|
|
Luksemburg |
Lundbeck S.A. Avenue Molière 225 1050 Brussels Belgium |
Redomex |
25 mg |
Filmom obložena tableta |
Kroz usta |
|
|
Luksemburg |
Lundbeck S.A. Avenue Molière 225 1050 Brussels Belgium |
Redomex Diffucaps |
25 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Luksemburg |
Lundbeck S.A. Avenue Molière 225 1050 Brussels Belgium |
Redomex Diffucaps |
50 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Nizozemska |
Lundbeck B.V. Gebouw Jupiter Herikerbergweg 100 Postbus 12021 1100 AA Amsterdam The Netherlands |
Sarotex Retard 25 |
25 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Nizozemska |
Lundbeck B.V. Gebouw Jupiter Herikerbergweg 100 Postbus 12021 1100 AA Amsterdam The Netherlands |
Sarotex Retard 50 |
50 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Norveška |
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark |
Sarotex |
10 mg |
Filmom obložena tableta |
Kroz usta |
|
|
Norveška |
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark |
Sarotex |
25 mg |
Filmom obložena tableta |
Kroz usta |
|
|
Norveška |
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark |
Sarotex Retard |
25 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Norveška |
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark |
Sarotex Retard |
50 mg |
Kapsula s produljenim oslobađanjem, tvrda |
Kroz usta |
|
|
Švedska |
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark |
Saroten |
10 mg |
Filmom obložena tableta |
Kroz usta |
|
|
Švedska |
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark |
Saroten |
25 mg |
Filmom obložena tableta |
Kroz usta |
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