# Službeni list C 32/25.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 32 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 62.25. siječnja 2019. |

ISSN 1977-1088

Službeni list

Europske unije

C 32

Hrvatsko izdanje

Informacije i objave

Godište 62.25. siječnja 2019.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2019/C 32/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2018. do 31. prosinca 2018.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2019/C 32/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2018. do 31. prosinca 2018.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 8 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2019/C 32/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2018. do 31. prosinca 2018.(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

2019/C 32/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2018. do 31. prosinca 2018.(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)

8

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

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 25.1.2019 | HR | Službeni list Europske unije | C 32/1 |
| --- | --- | --- | --- |

25.1.2019

HR

Službeni list Europske unije

C 32/1

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Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2018. do 31. prosinca 2018.

(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća (1))

(2019/C 32/01)

| — | 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 (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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.12.2018. | Dengvaxia | Četverovalentno cjepivo protiv denge (živo, atenuirano) | Sanofi Pasteur
  14 Espace Henry Vallée, 69007 Lyon, France | EU/1/18/1338 | Prašak i otapalo za suspenziju za injekciju | J07BX | 14.12.2018. |
| 12.12.2018. | Flucelvax Tetra | cjepivo protiv influence (površinski antigen, iz staničnih kultura), inaktivirano | Seqirus Netherlands B.V.
  Hullenbergweg 89 1101 CL Amsterdam, Nederland | EU/1/18/1326 | Suspenzija za injekciju | J07BB02 | 14.12.2018. |
| 12.12.2018. | Ogivri | trastuzumab | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1341 | Prašak za koncentrat za otopinu za infuziju | L01XC03 | 14.12.2018. |
| 18.12.2018. | Bevespi Aerosphere | glikopironijev bromid / formoterol | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/18/1339 | Stlačeni inhalat, suspenzija | R03AL07 | 20.12.2018. |
| 18.12.2018. | Namuscla | Meksiletin | Lupin Europe GmbH
  Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland | EU/1/18/1325 | Kapsula, tvrda | C01BB02 | 20.12.2018. |

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

12.12.2018.

Dengvaxia

Četverovalentno cjepivo protiv denge (živo, atenuirano)

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/18/1338

Prašak i otapalo za suspenziju za injekciju

J07BX

14.12.2018.

12.12.2018.

Flucelvax Tetra

cjepivo protiv influence (površinski antigen, iz staničnih kultura), inaktivirano

Seqirus Netherlands B.V.

Hullenbergweg 89 1101 CL Amsterdam, Nederland

EU/1/18/1326

Suspenzija za injekciju

J07BB02

14.12.2018.

12.12.2018.

Ogivri

trastuzumab

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1341

Prašak za koncentrat za otopinu za infuziju

L01XC03

14.12.2018.

18.12.2018.

Bevespi Aerosphere

glikopironijev bromid / formoterol

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1339

Stlačeni inhalat, suspenzija

R03AL07

20.12.2018.

18.12.2018.

Namuscla

Meksiletin

Lupin Europe GmbH

Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland

EU/1/18/1325

Kapsula, tvrda

C01BB02

20.12.2018.

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

—

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 |
| --- | --- | --- | --- | --- |
| 6.12.2018. | Exondys | AVI BioPharma International Ltd
  Tower Bridge House, St Katharine’s Way, London E1W 1DD, United Kingdom | — | 10.12.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

6.12.2018.

Exondys

AVI BioPharma International Ltd

Tower Bridge House, St Katharine’s Way, London E1W 1DD, United Kingdom

—

10.12.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 6.12.2018. | Anoro Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/898 | 10.12.2018. |
| 6.12.2018. | Avamys | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/07/434 | 10.12.2018. |
| 6.12.2018. | Darunavir Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1140 | 10.12.2018. |
| 7.12.2018. | Elocta | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/15/1046 | 12.12.2018. |
| 7.12.2018. | EVOTAZ | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1025 | 12.12.2018. |
| 7.12.2018. | Onivyde | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/16/1130 | 11.12.2018. |
| 7.12.2018. | Rubraca | Clovis Oncology Ireland Limited
  Regus Dublin Airport, Skybridge House – Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland | EU/1/17/1250 | 11.12.2018. |
| 7.12.2018. | Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1127 | 11.12.2018. |
| 7.12.2018. | Toujeo | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/00/133 | 11.12.2018. |
| 7.12.2018. | Ucedane | Eurocept International B.V.
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/17/1202 | 11.12.2018. |
| 7.12.2018. | Xermelo | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/17/1224 | 11.12.2018. |
| 7.12.2018. | Ziagen | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/99/112 | 11.12.2018. |
| 10.12.2018. | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/14/939 | 12.12.2018. |
| 10.12.2018. | Darunavir Krka | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1249 | 12.12.2018. |
| 10.12.2018. | Oncaspar | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes Cedex, France | EU/1/15/1070 | 12.12.2018. |
| 10.12.2018. | Xolair | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/319 | 12.12.2018. |
| 12.12.2018. | Desloratadine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/732 | 14.12.2018. |
| 12.12.2018. | Entyvio | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/923 | 14.12.2018. |
| 12.12.2018. | Evoltra | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/06/334 | 14.12.2018. |
| 12.12.2018. | Kengrexal | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/15/994 | 14.12.2018. |
| 12.12.2018. | Kevzara | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/17/1196 | 14.12.2018. |
| 12.12.2018. | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 14.12.2018. |
| 12.12.2018. | Mimpara | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/04/292 | 14.12.2018. |
| 12.12.2018. | Moventig | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/14/962 | 14.12.2018. |
| 12.12.2018. | OCALIVA | Intercept Pharma Ltd
  2 Pancras Square, London N1C 4AG, United Kingdom | EU/1/16/1139 | 17.12.2018. |
| 12.12.2018. | Pandemic influenza vaccine H5N1 BAXTER | Ology Bioservices Ireland LTD
  Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland | EU/1/09/571 | 18.12.2018. |
| 12.12.2018. | Praluent | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/15/1031 | 14.12.2018. |
| 12.12.2018. | Pregabalin Pfizer | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/14/916 | 14.12.2018. |
| 12.12.2018. | Reagila | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/17/1209 | 14.12.2018. |
| 12.12.2018. | Relvar Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/13/886 | 14.12.2018. |
| 12.12.2018. | Revinty Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/929 | 14.12.2018. |
| 12.12.2018. | RXULTI | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Nederland | EU/1/18/1294 | 14.12.2018. |
| 12.12.2018. | Trevicta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/971 | 14.12.2018. |
| 12.12.2018. | Triumeq | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/14/940 | 14.12.2018. |
| 12.12.2018. | Valdoxan | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes CEDEX, France | EU/1/08/499 | 14.12.2018. |
| 12.12.2018. | Vfend | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/02/212 | 14.12.2018. |
| 17.12.2018. | Dupixent | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/17/1229 | 19.12.2018. |
| 17.12.2018. | Elaprase | Shire Human Genetic Therapies AB
  Vasagatan 7, 111 20 Stockholm, Sverige | EU/1/06/365 | 19.12.2018. |
| 17.12.2018. | Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1133 | 19.12.2018. |
| 17.12.2018. | Epivir | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/96/015 | 19.12.2018. |
| 17.12.2018. | Hexacima | Sanofi Pasteur
  14 Espace Henry Vallée, 69007 Lyon, France | EU/1/13/828 | 19.12.2018. |
| 17.12.2018. | Hexyon | Sanofi Pasteur
  14 Espace Henry Vallée, 69007 Lyon, France | EU/1/13/829 | 19.12.2018. |
| 17.12.2018. | Kisqali | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/17/1221 | 19.12.2018. |
| 17.12.2018. | Zejula | TESARO Bio Netherlands B.V.
  Joop Geeskinkweg, 901, 1114AB, Amsterdam-Duisvendrecht, Nederland | EU/1/17/1235 | 19.12.2018. |
| 17.12.2018. | Zubsolv | Mundipharma Corporation (Ireland) Limited
  Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland | EU/1/17/1233 | 19.12.2018. |
| 18.12.2018. | Alimta | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/290 | 19.12.2018. |
| 18.12.2018. | Amyvid | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/12/805 | 20.12.2018. |
| 18.12.2018. | Darzalex | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/16/1101 | 20.12.2018. |
| 18.12.2018. | Granupas | Eurocept International B.V.
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/13/896 | 20.12.2018. |
| 18.12.2018. | Ledaga | Helsinn Birex Pharmaceuticals Ltd.
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/16/1171 | 20.12.2018. |
| 18.12.2018. | Mabthera | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/98/067 | 20.12.2018. |
| 18.12.2018. | Otezla | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/14/981 | 20.12.2018. |
| 18.12.2018. | Ravicti | Horizon Pharma Ireland Limited
  Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland | EU/1/15/1062 | 20.12.2018. |
| 18.12.2018. | Vectibix | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/07/423 | 20.12.2018. |
| 18.12.2018. | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/918 | 20.12.2018. |
| 20.12.2018. | Panretin | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/00/149 | 2.1.2019. |
| 20.12.2018. | Vihuma | Octapharma AB
  Lars Forssells gata 23, 112 75 Stockholm, Sverige | EU/1/16/1168 | 27.12.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

6.12.2018.

Anoro Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/898

10.12.2018.

6.12.2018.

Avamys

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/07/434

10.12.2018.

6.12.2018.

Darunavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1140

10.12.2018.

7.12.2018.

Elocta

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/15/1046

12.12.2018.

7.12.2018.

EVOTAZ

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/15/1025

12.12.2018.

7.12.2018.

Onivyde

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/16/1130

11.12.2018.

7.12.2018.

Rubraca

Clovis Oncology Ireland Limited

Regus Dublin Airport, Skybridge House – Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland

EU/1/17/1250

11.12.2018.

7.12.2018.

Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1127

11.12.2018.

7.12.2018.

Toujeo

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133

11.12.2018.

7.12.2018.

Ucedane

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/17/1202

11.12.2018.

7.12.2018.

Xermelo

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/17/1224

11.12.2018.

7.12.2018.

Ziagen

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/99/112

11.12.2018.

10.12.2018.

Daklinza

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/14/939

12.12.2018.

10.12.2018.

Darunavir Krka

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1249

12.12.2018.

10.12.2018.

Oncaspar

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/15/1070

12.12.2018.

10.12.2018.

Xolair

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/05/319

12.12.2018.

12.12.2018.

Desloratadine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/732

14.12.2018.

12.12.2018.

Entyvio

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/923

14.12.2018.

12.12.2018.

Evoltra

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/06/334

14.12.2018.

12.12.2018.

Kengrexal

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/15/994

14.12.2018.

12.12.2018.

Kevzara

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1196

14.12.2018.

12.12.2018.

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

14.12.2018.

12.12.2018.

Mimpara

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/04/292

14.12.2018.

12.12.2018.

Moventig

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/14/962

14.12.2018.

12.12.2018.

OCALIVA

Intercept Pharma Ltd

2 Pancras Square, London N1C 4AG, United Kingdom

EU/1/16/1139

17.12.2018.

12.12.2018.

Pandemic influenza vaccine H5N1 BAXTER

Ology Bioservices Ireland LTD

Wilton Park House, Wilton Place, Dublin 2, D02P447, Ireland

EU/1/09/571

18.12.2018.

12.12.2018.

Praluent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/15/1031

14.12.2018.

12.12.2018.

Pregabalin Pfizer

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/14/916

14.12.2018.

12.12.2018.

Reagila

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/17/1209

14.12.2018.

12.12.2018.

Relvar Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/13/886

14.12.2018.

12.12.2018.

Revinty Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/929

14.12.2018.

12.12.2018.

RXULTI

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/18/1294

14.12.2018.

12.12.2018.

Trevicta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/971

14.12.2018.

12.12.2018.

Triumeq

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/14/940

14.12.2018.

12.12.2018.

Valdoxan

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/08/499

14.12.2018.

12.12.2018.

Vfend

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/02/212

14.12.2018.

17.12.2018.

Dupixent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1229

19.12.2018.

17.12.2018.

Elaprase

Shire Human Genetic Therapies AB

Vasagatan 7, 111 20 Stockholm, Sverige

EU/1/06/365

19.12.2018.

17.12.2018.

Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1133

19.12.2018.

17.12.2018.

Epivir

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/96/015

19.12.2018.

17.12.2018.

Hexacima

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/13/828

19.12.2018.

17.12.2018.

Hexyon

Sanofi Pasteur

14 Espace Henry Vallée, 69007 Lyon, France

EU/1/13/829

19.12.2018.

17.12.2018.

Kisqali

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/17/1221

19.12.2018.

17.12.2018.

Zejula

TESARO Bio Netherlands B.V.

Joop Geeskinkweg, 901, 1114AB, Amsterdam-Duisvendrecht, Nederland

EU/1/17/1235

19.12.2018.

17.12.2018.

Zubsolv

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/17/1233

19.12.2018.

18.12.2018.

Alimta

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/290

19.12.2018.

18.12.2018.

Amyvid

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/12/805

20.12.2018.

18.12.2018.

Darzalex

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/16/1101

20.12.2018.

18.12.2018.

Granupas

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/896

20.12.2018.

18.12.2018.

Ledaga

Helsinn Birex Pharmaceuticals Ltd.

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/16/1171

20.12.2018.

18.12.2018.

Mabthera

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/98/067

20.12.2018.

18.12.2018.

Otezla

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/14/981

20.12.2018.

18.12.2018.

Ravicti

Horizon Pharma Ireland Limited

Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

EU/1/15/1062

20.12.2018.

18.12.2018.

Vectibix

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/07/423

20.12.2018.

18.12.2018.

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/918

20.12.2018.

20.12.2018.

Panretin

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/00/149

2.1.2019.

20.12.2018.

Vihuma

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/16/1168

27.12.2018.

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

—

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 |
| --- | --- | --- | --- | --- |
| 6.12.2018. | Ivabradine JensonR | JensonR+ Limited
  Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom | EU/1/16/1145 | 10.12.2018. |
| 17.12.2018. | Macugen | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c, 17000 Praha 7 Česká republika | EU/1/05/325 | 19.12.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

6.12.2018.

Ivabradine JensonR

JensonR+ Limited

Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom

EU/1/16/1145

10.12.2018.

17.12.2018.

Macugen

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c, 17000 Praha 7 Česká republika

EU/1/05/325

19.12.2018.

| — | Izdavanje odobrenja za stavljanje u promet (članak 38 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Odbijeno |
| --- | --- |

—

Izdavanje odobrenja za stavljanje u promet (članak 38 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 |
| --- | --- | --- | --- | --- |
| 12.12.2018. | LONGRANGE | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | — | 14.12.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

12.12.2018.

LONGRANGE

Merial

29 avenue Tony Garnier, 69007 Lyon, France

—

14.12.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 7.12.2018. | Aivlosin | ECO Animal Health Ltd
  78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom | EU/2/04/044 | 11.12.2018. |
| 7.12.2018. | Imrestor | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/15/193 | 11.12.2018. |
| 2.12.2018. | Aftovaxpur Doe | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/153 | 14.12.2018. |
| 17.12.2018. | Bovela | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/14/176 | 19.12.2018. |
| 17.12.2018. | Coxevac | Ceva Santé Animale
  10 avenue de la Ballastière, 33500 Libourne, France | EU/2/10/110 | 20.12.2018. |
| 17.12.2018. | Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/07/079 | 19.12.2018. |
| 17.12.2018. | Nobilis IB 4-91 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/98/006 | 19.12.2018. |
| 18.12.2018. | Nobilis IB Primo QX | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/14/174 | 20.12.2018. |
| 19.12.2018. | NexGard | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/159 | 21.12.2018. |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

7.12.2018.

Aivlosin

ECO Animal Health Ltd

78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom

EU/2/04/044

11.12.2018.

7.12.2018.

Imrestor

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/15/193

11.12.2018.

2.12.2018.

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/153

14.12.2018.

17.12.2018.

Bovela

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/14/176

19.12.2018.

17.12.2018.

Coxevac

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/10/110

20.12.2018.

17.12.2018.

Ingelvac CircoFLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/07/079

19.12.2018.

17.12.2018.

Nobilis IB 4-91

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/98/006

19.12.2018.

18.12.2018.

Nobilis IB Primo QX

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/174

20.12.2018.

19.12.2018.

NexGard

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/159

21.12.2018.

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 |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

(1)  SL L 136, 30.4.2004, str. 1.

---

| 25.1.2019 | HR | Službeni list Europske unije | C 32/8 |
| --- | --- | --- | --- |

25.1.2019

HR

Službeni list Europske unije

C 32/8

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. prosinca 2018. do 31. prosinca 2018.

(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ (1) ili člankom 38. Direktive 2001/82/EZ (2))

(2019/C 32/02)

| — | 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 |
| --- | --- | --- | --- | --- | --- |
| 18.12.2018. | Perlinring and associated names - | etonogestrel/ethinylestradiol | Vidi Prilog | Vidi Prilog | 19.12.2018. |

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

18.12.2018.

Perlinring and associated names -

etonogestrel/ethinylestradiol

Vidi Prilog

Vidi Prilog

19.12.2018.

---

(1)  SL L 311, 28.11.2001, str. 67.

(2)  SL L 311, 28.11.2001, str. 1.

---

PRILOG

Popis lijekova i farmaceutskih oblika

| Država članica EU-a/EGP-a | Podnositelj zahtjeva | (Novoizumljeno) ime | Jačina | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Austrija | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg pro 24 Stunden – Vaginalring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Belgija | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg par 24 heures, système de diffusion vaginal /
  Perlinring 0,120  mg/0,015  mg per 24 uur, hulpmiddel voor vaginaal gebruik | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Hrvatska | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg tijekom 24 sata, sustav za isporuku u rodnicu | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Češka Republika | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Danska | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Estonija | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Finska | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring
  0.120 mg/0.015 mg per 24 h depotlääkevalmiste, emättimeen | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Francuska | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 15 microgrammes/120 microgrammes/24 heures, système de diffusion vaginal | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Njemačka | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Mađarska | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg/24 óra hüvelyben alkalmazott gyógyszerleadó rendszer | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Island | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Irska | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Italija | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Latvija | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 120/15 mikrogramu 24 stundās vaginālās ievadīšanas sistēma | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Litva | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Ongavia 120/15 mikrogramų/24 valandas vartojimo į makštį sistema | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Nizozemska | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg per 24 uur, hulpmiddel voor vaginaal gebruik | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Norveška | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Poljska | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Portugal | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Rumunjska | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0,120  mg/0,015  mg/24 ore sistem cu cedare vaginalã | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Slovačka Republika | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Slovenija | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Etonogestrel/etinilestradiol Actavis 0,120  mg/0,015  mg na 24 ur vaginalni dostavni sistem | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Španjolska | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Pirlinring 0,120  mg/0,015  mg for cada 24 horas, sistema de liberación vaginal | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Švedska | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |
| Ujedinjeno Kraljevstvo | Actavis Group PTC ehf
  Reykjavikurvegi 76-78
  220 Hafnarfjördur, Iceland | Perlinring 0.015 mg/0.12 mg/ 24 hours Vaginal Delivery System | 0,120  mg/0,015  mg u 24 sata | Sustav vaginalne isporuke | Vaginalna primjena |

Država članica EU-a/EGP-a

Podnositelj zahtjeva

(Novoizumljeno) ime

Jačina

Farmaceutski oblik

Put primjene

Austrija

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg pro 24 Stunden – Vaginalring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Belgija

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg par 24 heures, système de diffusion vaginal /

Perlinring 0,120  mg/0,015  mg per 24 uur, hulpmiddel voor vaginaal gebruik

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Hrvatska

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg tijekom 24 sata, sustav za isporuku u rodnicu

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Češka Republika

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Danska

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Estonija

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Finska

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0.120 mg/0.015 mg per 24 h depotlääkevalmiste, emättimeen

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Francuska

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 15 microgrammes/120 microgrammes/24 heures, système de diffusion vaginal

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Njemačka

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Mađarska

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg/24 óra hüvelyben alkalmazott gyógyszerleadó rendszer

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Island

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Irska

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Italija

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Latvija

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 120/15 mikrogramu 24 stundās vaginālās ievadīšanas sistēma

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Litva

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Ongavia 120/15 mikrogramų/24 valandas vartojimo į makštį sistema

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Nizozemska

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg per 24 uur, hulpmiddel voor vaginaal gebruik

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Norveška

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Poljska

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Portugal

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Rumunjska

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0,120  mg/0,015  mg/24 ore sistem cu cedare vaginalã

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Slovačka Republika

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Slovenija

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Etonogestrel/etinilestradiol Actavis 0,120  mg/0,015  mg na 24 ur vaginalni dostavni sistem

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Španjolska

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Pirlinring 0,120  mg/0,015  mg for cada 24 horas, sistema de liberación vaginal

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Švedska

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

Ujedinjeno Kraljevstvo

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur, Iceland

Perlinring 0.015 mg/0.12 mg/ 24 hours Vaginal Delivery System

0,120  mg/0,015  mg u 24 sata

Sustav vaginalne isporuke

Vaginalna primjena

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