# Uradni list C 180/2019

| | ISSN 1977-1045 |
| --- | --- |
| Uradni list
  Evropske unije | C 180 |
| | |
| Slovenska izdaja | Informacije in objave | Letnik 6224. maj 2019 |

ISSN 1977-1045

Uradni list

Evropske unije

C 180

Slovenska izdaja

Informacije in objave

Letnik 6224. maj 2019

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| Vsebina | Stran |
| --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska komisija |
| 2019/C 180/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2019 do 30. aprila 2019(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
  11 ) | 1 |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| 2019/C 180/02 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2019 do 30. aprila 2019(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
  11 ali člena 38 Direktive 2001/82/ES
  22
  ) | 16 |

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

2019/C 180/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2019 do 30. aprila 2019(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
  11 )

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta

11 )

1

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

2019/C 180/02

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2019 do 30. aprila 2019(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
  11 ali člena 38 Direktive 2001/82/ES
  22
  )

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES

11 ali člena 38 Direktive 2001/82/ES

22

)

16

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| SL | |
| --- | --- |

SL

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IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

| 24.5.2019 | SL | Uradni list Evropske unije | C 180/1 |
| --- | --- | --- | --- |

24.5.2019

SL

Uradni list Evropske unije

C 180/1

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Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2019 do 30. aprila 2019

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (1)
  )

(2019/C 180/01)

| — | Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena |
| --- | --- |

—

Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.4.2019 | Idacio | adalimumab | Fresenius Kabi Deutschland GmbH |
| Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

2.4.2019

Idacio

adalimumab

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/19/1356

Rztopina za injiciranje

L04AB04

4.4.2019

2.4.2019

Kromeya

adalimumab

| Fresenius Kabi Deutschland GmbH |
| --- |
| Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

EU/1/19/1357

Rztopina za injiciranje

L04AB04

4.4.2019

2.4.2019

Vizimpro

dakomitinib

| Pfizer Europe MA EEIG |
| --- |
| Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |

Pfizer Europe MA EEIG

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

EU/1/19/1354

Filmsko obložene tablete

L01XE47

4.4.2019

26.4.2019

Dectova

zanamivir

| GlaxoSmithKline Trading Services Limited |
| --- |
| Currabinny, Carrigaline, County Cork, Ireland |

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/18/1349

Raztopina za infundiranje

J05AH01

30.4.2019

26.4.2019

Ondexxya

andeksanet alfa

| Portola Netherlands B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB, Amsterdam, Netherlands |

Portola Netherlands B.V.

Prins Bernhardplein 200, 1097 JB, Amsterdam, Netherlands

EU/1/18/1345

Prašek za raztopino za infundiranje

V03AB38

30.4.2019

26.4.2019

Skyrizi

risankizumab

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1361

Rztopina za injiciranje

L04AC

30.4.2019

26.4.2019

Zynquista

sotagliflozin

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/19/1363

Filmsko obložene tablete

A10BK06

30.4.2019

| — | Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena |
| --- | --- |

—

Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 2.4.2019 | Afinitor | Novartis Europharm Limited |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

2.4.2019

Afinitor

Novartis Europharm Limited

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

EU/1/09/538

4.4.2019

2.4.2019

Betmiga

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, 2333 BE Leiden, Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/12/809

4.4.2019

2.4.2019

Clopidogrel BGR

| Laboratoires BIOGARAN |
| --- |
| 15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France |

Laboratoires BIOGARAN

15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France

EU/1/09/558

4.4.2019

2.4.2019

Copalia

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/06/372

4.4.2019

2.4.2019

Dafiro

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/06/371

4.4.2019

2.4.2019

Deltyba

| Otsuka Novel Products GmbH |
| --- |
| Erika-Mann-Straße 21, 80636 München, Deutschland |

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

4.4.2019

2.4.2019

Eliquis

| Bristol-Myers Squibb/Pfizer EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D 15 T867, Ireland |

Bristol-Myers Squibb/Pfizer EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D 15 T867, Ireland

EU/1/11/691

4.4.2019

2.4.2019

Empliciti

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D 15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D 15 T867, Dublin 15, Ireland

EU/1/16/1088

4.4.2019

2.4.2019

Exforge HCT

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/09/569

4.4.2019

2.4.2019

Gazyvaro

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

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

EU/1/14/937

4.4.2019

2.4.2019

Irbesartan Zentiva

| Zentiva k.s. |
| --- |
| U kabelovny 130, 102 37 Praha 10, Česká republika |

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/376

4.4.2019

2.4.2019

Kapecitabin Accord

| Accord Healthcare S.L.U. |
| --- |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/12/762

4.4.2019

2.4.2019

Karvea

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/97/049

4.4.2019

2.4.2019

Karvezide

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/085

4.4.2019

2.4.2019

Lumark

| IDB Holland B.V. |
| --- |
| Weverstraat 17, 5111 PV Baarle-Nassau, Nederland |

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

4.4.2019

2.4.2019

NULOJIX

| Bristol-Myers Squibb/Pfizer EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D 15 T867, Ireland |

Bristol-Myers Squibb/Pfizer EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D 15 T867, Ireland

EU/1/11/694

4.4.2019

2.4.2019

Opdivo

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D 15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D 15 T867, Dublin 15, Ireland

EU/1/15/1014

4.4.2019

2.4.2019

Steglatro

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1267

4.4.2019

2.4.2019

Steglujan

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1266

4.4.2019

2.4.2019

Sylvant

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/928

4.4.2019

2.4.2019

Vidaza

| Celgene Europe B.V. |
| --- |
| Winthontlaan 6 N, 3526 KV Utrecht, Nederland |

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/488

4.4.2019

2.4.2019

Yervoy

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D 15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D 15 T867, Dublin 15, Ireland

EU/1/11/698

4.4.2019

2.4.2019

Zonisamide Mylan

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1093

4.4.2019

2.4.2019

Zykadia

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/15/999

4.4.2019

8.4.2019

Actraphane

| Novo Nordisk A/S |
| --- |
| Novo Allé, 2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/229

10.4.2019

8.4.2019

BiResp Spiromax

| Teva Pharma B.V. |
| --- |
| Swensweg 5, 2031GA Haarlem, Nederland |

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/921

10.4.2019

8.4.2019

DuoResp Spiromax

| Teva Pharma B.V. |
| --- |
| Swensweg 5, 2031GA Haarlem, Nederland |

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/920

10.4.2019

8.4.2019

Iressa

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/09/526

10.4.2019

8.4.2019

Kapecitabin medac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstraße 6, 22880 Wedel, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/802

10.4.2019

8.4.2019

Lantus

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main, Deutschland |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134

10.4.2019

8.4.2019

Lynparza

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

10.4.2019

8.4.2019

M-M-RVAXPRO

| MSD VACCINS |
| --- |
| 162 avenue Jean Jaurès, 69007 Lyon, France |

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/337

10.4.2019

8.4.2019

Orencia

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D 15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D 15 T867, Dublin 15, Ireland

EU/1/07/389

10.4.2019

8.4.2019

Riarify

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, 43122 Parma, Italia |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1275

10.4.2019

8.4.2019

Ritemvia

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/17/1207

10.4.2019

8.4.2019

Stribild

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/830

10.4.2019

8.4.2019

Tybost

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

10.4.2019

8.4.2019

Viread

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/01/200

10.4.2019

8.4.2019

Zerit

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D 15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D 15 T867, Dublin 15, Ireland

EU/1/96/009

10.4.2019

9.4.2019

Esbriet

| Roche Registration GmbH |
| --- |
| Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |

Roche Registration GmbH

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

EU/1/11/667

11.4.2019

9.4.2019

Ifirmacombi

| Krka d. d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/673

11.4.2019

9.4.2019

Rituzena

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/17/1206

11.4.2019

9.4.2019

Trydonis

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, 43122 Parma, Italia |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1274

11.4.2019

11.4.2019

Aprovel

| Sanofi Clir SNC |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/97/046

15.4.2019

11.4.2019

Cervarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l’Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

15.4.2019

11.4.2019

CoAprovel

| Sanofi Clir SNC |
| --- |
| 54 rue La Boétie, 75008 Paris, France |

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/98/086

15.4.2019

11.4.2019

Copalia HCT

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/09/575

15.4.2019

11.4.2019

Dafiro HCT

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/09/574

15.4.2019

11.4.2019

Ebilfumin

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/14/915

15.4.2019

11.4.2019

Exforge

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/06/370

15.4.2019

11.4.2019

Irbesartan / hidroklorotiazid Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

15.4.2019

11.4.2019

Irbesartan Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/576

15.4.2019

11.4.2019

Lamivudine Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/566

15.4.2019

11.4.2019

Leganto

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/11/695

15.4.2019

11.4.2019

Lokelma

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

15.4.2019

11.4.2019

Neparvis

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/16/1103

15.4.2019

11.4.2019

Pemetrexed Lilly

| Eli Lilly Nederland B.V. |
| --- |
| Papendorpseweg 83, 3528 BJ Utrecht, Nederland |

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1034

15.4.2019

11.4.2019

Pregabalin Zentiva

| Zentiva, k.s. |
| --- |
| U Kabelovny 130, 102 37 Praha 10, Česká republika |

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1021

15.4.2019

11.4.2019

Spherox

| CO.DON AG |
| --- |
| Warthestraße 21, 14513 Teltow, Deutschland |

CO.DON AG

Warthestraße 21, 14513 Teltow, Deutschland

EU/1/17/1181

15.4.2019

11.4.2019

Starlix

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/01/174

15.4.2019

11.4.2019

Truxima

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/16/1167

15.4.2019

11.4.2019

Zutectra

| Biotest Pharma GmbH |
| --- |
| Landsteinerstraße 5, 63303 Dreieich, Deutschland |

Biotest Pharma GmbH

Landsteinerstraße 5, 63303 Dreieich, Deutschland

EU/1/09/600

15.4.2019

15.4.2019

Ecansya

| Krka d. d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/12/763

17.4.2019

15.4.2019

Entresto

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/15/1058

17.4.2019

15.4.2019

Ifirmasta

| Krka d. d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/480

17.4.2019

15.4.2019

Irbesartan HCT Zentiva

| Zentiva k.s. |
| --- |
| U kabelovny 130, 102 37 Praha 10, Česká republika |

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/377

17.4.2019

15.4.2019

Yargesa

| Piramal Critical Care B.V. |
| --- |
| Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland |

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland

EU/1/17/1176

17.4.2019

17.4.2019

Amlodipin/valsartan Mylan

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1092

24.4.2019

17.4.2019

Caelyx

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, 2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/96/011

24.4.2019

17.4.2019

Cimzia

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/09/544

24.4.2019

17.4.2019

Clopidogrel Apotex

| Apotex Europe B.V. |
| --- |
| Archimedesweg 2, 2333 CN Leiden, Nederland |

Apotex Europe B.V.

Archimedesweg 2, 2333 CN Leiden, Nederland

EU/1/09/568

24.4.2019

17.4.2019

Clopidogrel HCS

| HCS bvba |
| --- |
| H. Kennisstraat 53, 2650 Edegem, België |

HCS bvba

H. Kennisstraat 53, 2650 Edegem, België

EU/1/10/651

24.4.2019

17.4.2019

Cuprymina

| SPARKLE S.r.l. |
| --- |
| Località Cavallino, 62010 Montecosaro (MC), Italia |

SPARKLE S.r.l.

Località Cavallino, 62010 Montecosaro (MC), Italia

EU/1/12/784

24.4.2019

17.4.2019

Miglustat Dipharma

| Dipharma B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland |

Dipharma B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/18/1346

24.4.2019

17.4.2019

Pandemic influenza vaccine H5N 1 AstraZeneca

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sverige |

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1089

24.4.2019

17.4.2019

Rydapt

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/17/1218

24.4.2019

17.4.2019

Semglee

| Mylan S.A.S. |
| --- |
| 117 allée des Parcs, 69800 Saint Priest, France |

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1270

24.4.2019

17.4.2019

SonoVue

| Bracco International B.V. |
| --- |
| Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland |

Bracco International B.V.

Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland

EU/1/01/177

24.4.2019

17.4.2019

Zubsolv

| Orexo AB |
| --- |
| Box 303, 751 05 Uppsala, Sverige |

Orexo AB

Box 303, 751 05 Uppsala, Sverige

EU/1/17/1233

24.4.2019

24.4.2019

Orphacol

| Laboratoires CTRS |
| --- |
| 63 rue de l’Est, 92100 Boulogne-Billancourt, France |

Laboratoires CTRS

63 rue de l’Est, 92100 Boulogne-Billancourt, France

EU/1/13/870

26.4.2019

26.4.2019

Aimovig

| Novartis Europharm Limited |
| --- |
| Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |

Novartis Europharm Limited

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

EU/1/18/1293

30.4.2019

26.4.2019

Ameluz

| Biofrontera Bioscience GmbH |
| --- |
| Hemmelrather Weg 201, 51377 Leverkusen, Deutschland |

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, 51377 Leverkusen, Deutschland

EU/1/11/740

30.4.2019

26.4.2019

Kyprolis

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

30.4.2019

26.4.2019

Lonquex

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/856

30.4.2019

26.4.2019

Nuwiq

| Octapharma AB |
| --- |
| Lars Forssells gata 23, 112 75 Stockholm, Sverige |

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/14/936

30.4.2019

26.4.2019

Oncaspar

| Les Laboratoires Servier |
| --- |
| 50 rue Carnot, 92284 Suresnes Cedex, France |

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes Cedex, France

EU/1/15/1070

30.4.2019

26.4.2019

Picato

| LEO Laboratories Ltd |
| --- |
| 285 Cashel Road, Crumlin, Dublin 12, Ireland |

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

30.4.2019

26.4.2019

RotaTeq

| MSD VACCINS |
| --- |
| 162 avenue Jean Jaurès, 69007 Lyon, France |

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/348

30.4.2019

26.4.2019

Spectrila

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Theaterstraße 6, 22880 Wedel, Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/15/1072

30.4.2019

29.4.2019

Abilify

| Otsuka Pharmaceutical Netherlands B.V. |
| --- |
| Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland |

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland

EU/1/04/276

1.5.2019

29.4.2019

ABILIFY MAINTENA

| Otsuka Pharmaceutical Netherlands B.V. |
| --- |
| Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland |

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland

EU/1/13/882

1.5.2019

29.4.2019

Aripiprazole Sandoz

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1029

2.5.2019

29.4.2019

Humira

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

2.5.2019

29.4.2019

Kaletra

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/01/172

2.5.2019

29.4.2019

Lemtrada

| Sanofi Belgium |
| --- |
| Leonardo Da Vincilaan 19, B-1831 Diegem, België |

Sanofi Belgium

Leonardo Da Vincilaan 19, B-1831 Diegem, België

EU/1/13/869

2.5.2019

29.4.2019

Maviret

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

2.5.2019

29.4.2019

Miglustat Gen.Orph

| Gen.Orph |
| --- |
| 185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France |

Gen.Orph

185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France

EU/1/17/1232

2.5.2019

29.4.2019

Natpar

| Shire Pharmaceuticals Ireland Limited |
| --- |
| Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland |

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland

EU/1/15/1078

1.5.2019

29.4.2019

Norvir

| AbbVie Deutschland GmbH & Co. KG |
| --- |
| Knollstrasse, 67061 Ludwigshafen, Deutschland |

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/96/016

2.5.2019

29.4.2019

Repatha

| Amgen Europe B.V. |
| --- |
| Minervum 7061, 4817 ZK Breda, Nederland |

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

1.5.2019

30.4.2019

Zydelig

| Gilead Sciences Ireland UC |
| --- |
| Carrigtohill, County Cork, T45 DP77, Ireland |

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/938

3.5.2019

| — | Ukinitev dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) |
| --- | --- |

—

Ukinitev dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 2.4.2019 | Numient | Amneal Pharma Europe Ltd |
| 70 Sir John Rogerson’s Quay, Dublin 2, Ireland |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

2.4.2019

Numient

Amneal Pharma Europe Ltd

70 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/15/1044

4.4.2019

10.4.2019

Rituzena

| Celltrion Healthcare Hungary Kft. |
| --- |
| Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország |

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/17/1206

12.4.2019

11.4.2019

Topotecan Teva

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/552

15.4.2019

15.4.2019

Airexar Spiromax

| Teva B.V. |
| --- |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/16/1123

17.4.2019

| — | Izdaja dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena |
| --- | --- |

—

Izdaja dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.4.2019 | Chanhold | selamektin | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, Co. Galway, Ireland |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

17.4.2019

Chanhold

selamektin

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/19/236

Kožni nanos, raztopina

QP54AA05

24.4.2019

23.4.2019

Forceris

toltrazuril / gleptoferona

| Ceva Santé Animale |
| --- |
| 10 avenue de la Ballastière, 33500 Libourne, France |

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/19/235

Suspenzija za injiciranje

QP51AJ51

25.4.2019

26.4.2019

Felisecto Plus

Selamektin/sarolaner

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/19/238

Kožni nanos, raztopina

QP54AA55

30.4.2019

26.4.2019

ReproCyc ParvoFLEX

Cepivo za prašičje parvovirozo(inaktivirano)

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/19/237

Suspenzija za injiciranje

QI09AA02

30.4.2019

| — | Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena |
| --- | --- |

—

Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 8.4.2019 | Versican Plus DHPPi/L4 | Zoetis Belgium S.A. |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

8.4.2019

Versican Plus DHPPi/L4

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/14/164

10.4.2019

8.4.2019

Versican Plus DHPPi/L4R

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/14/163

10.4.2019

8.4.2019

Versican Plus L4

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/14/171

10.4.2019

11.4.2019

Convenia

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/06/059

15.4.2019

11.4.2019

Suvaxyn PRRS MLV

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/17/215

15.4.2019

11.4.2019

Versican Plus Pi/L4

| Zoetis Belgium S.A. |
| --- |
| rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/14/172

15.4.2019

23.4.2019

Innovax-ILT

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/182

25.4.2019

26.4.2019

ERYSENG PARVO

| Laboratorios Hipra, S.A. |
| --- |
| Avda. La Selva, 135, 17170 Amer (Girona), España |

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170 Amer (Girona), España

EU/2/14/167

30.4.2019

26.4.2019

ProZinc

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/2/13/152

30.4.2019

Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| The Netherlands |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

---

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

---

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

| 24.5.2019 | SL | Uradni list Evropske unije | C 180/16 |
| --- | --- | --- | --- |

24.5.2019

SL

Uradni list Evropske unije

C 180/16

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2019 do 30. aprila 2019

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES (1)
  ali člena 38 Direktive 2001/82/ES (2)
  )

(2019/C 180/02)

| — | Izdaja, ohranjanje ali sprememba nacionalnega dovoljenja za promet |
| --- | --- |

—

Izdaja, ohranjanje ali sprememba nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- | --- |
| 2.4.2019 | Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group | sartan | Ni relevantno | Ni relevantno | 3.4.2019 |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

2.4.2019

Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

sartan

Ni relevantno

Ni relevantno

3.4.2019

---

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

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

---