# Službeni list C 208/30.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 208 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 60.30. lipnja 2017. |

ISSN 1977-1088

Službeni list

Europske unije

C 208

Hrvatsko izdanje

Informacije i objave

Godište 60.30. lipnja 2017.

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| Obavijest br. | Sadržaj | Stranica |
| --- | --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2017/C 208/01 | 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 208/02 | 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 ili člankom 38. Direktive 2001/82/EZ) | 10 |

Obavijest br.

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2017/C 208/01

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)

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća)

1

2017/C 208/02

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 ili člankom 38. Direktive 2001/82/EZ)

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ)

10

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| HR | |
| --- | --- |

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 30.6.2017 | HR | Službeni list Europske unije | C 208/1 |
| --- | --- | --- | --- |

30.6.2017

HR

Službeni list Europske unije

C 208/1

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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)

| — | Izdavanje odobrenja za stavljanje u promet (članak 13. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno |
| --- | --- |

—

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. |

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 |
| --- | --- |

—

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. |
| 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. |
| 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. |
| 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. |
| 16.5.2017. | Feraccru | Shield TX (UK) Limited
  Gateshead Quays, NE8 3DF, United Kingdom | EU/1/15/1075 | 18.5.2017. |
| 16.5.2017. | Lysodren | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Pariz, France | EU/1/04/273 | 18.5.2017. |
| 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. |
| 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. |
| 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. |
| 16.5.2017. | Obizur | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/15/1035 | 18.5.2017. |
| 16.5.2017. | Tygacil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/336 | 18.5.2017. |
| 18.5.2017. | Brilique | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/10/655 | 23.5.2017. |
| 18.5.2017. | Desloratadine Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/11/745 | 23.5.2017. |
| 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. |
| 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. |

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.

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.

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.

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.

16.5.2017.

Feraccru

Shield TX (UK) Limited

Gateshead Quays, NE8 3DF, United Kingdom

EU/1/15/1075

18.5.2017.

16.5.2017.

Lysodren

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Pariz, France

EU/1/04/273

18.5.2017.

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.

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.

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.

16.5.2017.

Obizur

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/15/1035

18.5.2017.

16.5.2017.

Tygacil

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/336

18.5.2017.

18.5.2017.

Brilique

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/10/655

23.5.2017.

18.5.2017.

Desloratadine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/745

23.5.2017.

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.

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 |
| --- | --- |

—

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. |

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 |
| --- | --- |

—

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. |

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 |

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 |
| --- | --- | --- | --- |

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)

| — | Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet |
| --- | --- |

—

Izdavanje, zadržavanje ili izmjena nacionalnog odobrenja za stavljanje u promet

| 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 |
| --- | --- | --- | --- | --- | --- |
| 5. svibnja 2017. | Saroten and associated names | amitriptyline | Vidjeti Prilog | Vidjeti Prilog | 10. svibnja 2017. |

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

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

| 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 | |
| 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 | |
| Estonija | H. Lundbeck A/S
  Ottiliavej 9
  2500 Valby
  Denmark | Saroten Retard | 50 mg | Kapsula s produljenim oslobađanjem, tvrda | Kroz usta | |
| 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 | |
| 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 | |
| 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 | |

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

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

Estonija

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Saroten Retard

50 mg

Kapsula s produljenim oslobađanjem, tvrda

Kroz usta

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

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

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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