# Uradni list C 204/28.

| | ISSN 1977-1045 |
| --- | --- |
| Uradni list
  Evropske unije | C 204 |
| | |
| Slovenska izdaja | Informacije in objave | Letnik 6428. maj 2021 |

ISSN 1977-1045

Uradni list

Evropske unije

C 204

Slovenska izdaja

Informacije in objave

Letnik 6428. maj 2021

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| Vsebina | Stran |
| --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska komisija |
| 2021/C 204/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2021 do 30. aprila 2021(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) | 1 |
| 2021/C 204/02 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2021 do 30. aprila 2021(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES) | 10 |

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

2021/C 204/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2021 do 30. aprila 2021(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

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

1

2021/C 204/02

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2021 do 30. aprila 2021(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES)

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

10

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

SL

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IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

| 28.5.2021 | SL | Uradni list Evropske unije | C 204/1 |
| --- | --- | --- | --- |

28.5.2021

SL

Uradni list Evropske unije

C 204/1

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Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2021 do 30. aprila 2021

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

(2021/C 204/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.4.2021 | Abevmy | bevacizumab | Mylan IRE Healthcare Limited |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, 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

21.4.2021

Abevmy

bevacizumab

Mylan IRE Healthcare Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/20/1515

Koncentrat za raztopino za infundiranje

L01XC07

22.4.2021

21.4.2021

JEMPERLI

dostarlimab

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/21/1538

Koncentrat za raztopino za infundiranje

L01XC40

22.4.2021

21.4.2021

Lextemy

bevacizumab

| Mylan IRE Healthcare Limited |
| --- |
| Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |

Mylan IRE Healthcare Limited

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

EU/1/20/1516

Koncentrat za raztopino za infundiranje

L01XC07

22.4.2021

26.4.2021

Abiraterone Accord

abirateronacetat

| 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/1/20/1512

Filmsko obložene tablete

Tableta

L02BX03

30.4.2021

30.4.2021

Orladeyo

berotralstat

| Biocryst Ireland Limited |
| --- |
| Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland |

Biocryst Ireland Limited

Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland

EU/1/21/1544

Kapsula, trda

B06AC

4.5.2021

30.4.2021

Sibnayal

kalijev citrat/kalijev hidrogenkarbonat

| ADVICENNE |
| --- |
| 22, rue de la Paix, 75002 Paris, France |

ADVICENNE

22, rue de la Paix, 75002 Paris, France

EU/1/20/1517

Zrnca s podaljšanim sproščanjem

A12BA30

3.5.2021

—   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 |
| --- | --- | --- | --- | --- |
| 7.4.2021 | Effentora | Teva B.V. |
| Swensweg 5, 2031 GA Haarlem, Nederland |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

7.4.2021

Effentora

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/441

8.4.2021

7.4.2021

Instanyl

| Takeda Pharma A/S |
| --- |
| Dybendal Alle 10, 2630 Taastrup, Danmark |

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/09/531

8.4.2021

7.4.2021

Trimbow

| 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/1/17/1208

8.4.2021

8.4.2021

Vaxzevria

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

8.4.2021

13.4.2021

Aerinaze

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/07/399

16.4.2021

13.4.2021

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

14.4.2021

13.4.2021

Neoclarityn

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/00/161

22.4.2021

13.4.2021

OPDIVO

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/15/1014

14.4.2021

13.4.2021

Orgalutran

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/00/130

16.4.2021

13.4.2021

Vantavo

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/09/572

16.4.2021

14.4.2021

Comirnaty

| BioNTech Manufacturing GmbH |
| --- |
| An der Goldgrube 12, 55131 Mainz, Deutschland |

BioNTech Manufacturing GmbH

An der Goldgrube 12, 55131 Mainz, Deutschland

EU/1/20/1528

14.4.2021

15.4.2021

Natpar

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

Shire Pharmaceuticals Ireland Limited

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

EU/1/15/1078

16.4.2021

15.4.2021

Sarclisa

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/20/1435

16.4.2021

15.4.2021

Xromi

| Nova Laboratories Ireland Limited |
| --- |
| 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland |

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland

EU/1/19/1366

16.4.2021

16.4.2021

Cholestagel

| CHEPLAPHARM Arzneimittel GmbH |
| --- |
| Ziegelhof 24, 17489 Greifswald, Deutschland |

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/03/268

27.4.2021

16.4.2021

Dynastat

| 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/1/02/209

19.4.2021

16.4.2021

Entecavir 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/1/17/1227

26.4.2021

16.4.2021

Epidyolex

| GW Pharma (International) B.V. |
| --- |
| Databankweg 26, 3821AL Amersfoort, Nederland |

GW Pharma (International) B.V.

Databankweg 26, 3821AL Amersfoort, Nederland

EU/1/19/1389

20.4.2021

16.4.2021

EVOTAZ

| Bristol-Myers Squibb/Pfizer EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland |

Bristol-Myers Squibb/Pfizer EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

EU/1/15/1025

19.4.2021

16.4.2021

Imvanex

| Bavarian Nordic A/S |
| --- |
| Philip Heymans Allé 3, DK-2900 Hellerup, Danmark |

Bavarian Nordic A/S

Philip Heymans Allé 3, DK-2900 Hellerup, Danmark

EU/1/13/855

27.4.2021

16.4.2021

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

20.4.2021

16.4.2021

Macimorelin Consilient Health

| Consilient Health Ltd |
| --- |
| 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland |

Consilient Health Ltd

5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

EU/1/18/1337

26.4.2021

16.4.2021

Maviret

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

20.4.2021

16.4.2021

Pegasys

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

Roche Registration GmbH

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

EU/1/02/221

26.4.2021

16.4.2021

Pelgraz

| 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/1/18/1313

20.4.2021

16.4.2021

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

19.4.2021

16.4.2021

SANCUSO

| Kyowa Kirin Holdings B.V. |
| --- |
| Bloemlaan 2, 2132 NP Hoofddorp, Nederland |

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/12/766

26.4.2021

16.4.2021

Taxotere

| Sanofi Mature IP |
| --- |
| 54 rue La Boétie, 75008, Paris, France |

Sanofi Mature IP

54 rue La Boétie, 75008, Paris, France

EU/1/95/002

29.4.2021

16.4.2021

Xaluprine

| Nova Laboratories Ireland Limited |
| --- |
| 3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland |

Nova Laboratories Ireland Limited

3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland

EU/1/11/727

19.4.2021

16.4.2021

Xerava

| PAION Deutschland GmbH |
| --- |
| Heussstraße 25, 52078 Aachen, Deutschland |

PAION Deutschland GmbH

Heussstraße 25, 52078 Aachen, Deutschland

EU/1/18/1312

19.4.2021

21.4.2021

Adrovance

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/06/364

26.4.2021

21.4.2021

Avamys

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/07/434

28.4.2021

21.4.2021

CABOMETYX

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/16/1136

22.4.2021

21.4.2021

Fosavance

| N.V. Organon |
| --- |
| Kloosterstraat 6, 5349 AB Oss, Nederland |

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/05/310

26.4.2021

21.4.2021

Fycompa

| Eisai GmbH |
| --- |
| Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland |

Eisai GmbH

Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland

EU/1/12/776

22.4.2021

21.4.2021

INCRELEX

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/07/402

22.4.2021

21.4.2021

Insulin aspart Sanofi

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/20/1447

22.4.2021

21.4.2021

Lyumjev

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1422

22.4.2021

21.4.2021

Macimorelin Consilient Health

| Consilient Health Ltd |
| --- |
| 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland |

Consilient Health Ltd

5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

EU/1/18/1337

23.4.2021

21.4.2021

Mvasi

| Amgen Technology (Ireland) UC |
| --- |
| Pottery Road, Dun Laoghaire, Co. Dublin, Ireland |

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

26.2.2021

21.4.2021

Mvasi

| Amgen Technology (Ireland) UC |
| --- |
| Pottery Road, Dun Laoghaire, Co. Dublin, Ireland |

Amgen Technology (Ireland) UC

Pottery Road, Dun Laoghaire, Co. Dublin, Ireland

EU/1/17/1246

22.4.2021

21.4.2021

NUBEQA

| Bayer AG |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/20/1432

22.4.2021

21.4.2021

Ontruzant

| Samsung Bioepis NL B.V. |
| --- |
| Olof Palmestraat 10, 2616 LR Delft, Nederland |

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1241

23.4.2021

21.4.2021

OPDIVO

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/15/1014

26.4.2021

21.4.2021

Oslif Breezhaler

| 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/1/09/586

22.4.2021

21.4.2021

Pemetrexed Fresenius Kabi

| 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/1/16/1115

23.4.2021

21.4.2021

Qtern

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1108

22.4.2021

21.4.2021

Ritonavir 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/1/17/1242

23.4.2021

21.4.2021

RoActemra

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

Roche Registration GmbH

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

EU/1/08/492

23.4.2021

21.4.2021

Slenyto

| RAD Neurim Pharmaceuticals EEC SARL |
| --- |
| 4 rue de Marivaux, 75002 Paris, France |

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/18/1318

28.4.2021

21.4.2021

Stocrin

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

26.4.2021

21.4.2021

Tegsedi

| Akcea Therapeutics Ireland Ltd |
| --- |
| Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland |

Akcea Therapeutics Ireland Ltd

Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland

EU/1/18/1296

22.4.2021

21.4.2021

Trogarzo

| Theratechnologies Europe Limited |
| --- |
| 4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland |

Theratechnologies Europe Limited

4th Floor, 2 Hume Street, Dublin 2, D02 DV24, Ireland

EU/1/19/1359

26.4.2021

21.4.2021

Valdoxan

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

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/08/499

22.4.2021

21.4.2021

Vosevi

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

22.4.2021

22.4.2021

COVID-19 Vaccine Janssen

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

22.4.2021

26.4.2021

Aerius

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/160

30.4.2021

26.4.2021

Atazanavir 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/1/16/1091

27.4.2021

26.4.2021

Kaftrio

| Vertex Pharmaceuticals (Ireland) Limited |
| --- |
| 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/20/1468

5.5.2021

26.4.2021

Kalydeco

| Vertex Pharmaceuticals (Ireland) Limited |
| --- |
| 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |

Vertex Pharmaceuticals (Ireland) Limited

28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

EU/1/12/782

5.5.2021

26.4.2021

Levetiracetam Hospira

| 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/1/13/889

28.4.2021

26.4.2021

Saxenda

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

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

5.5.2021

28.4.2021

Bortezomib Hospira

| 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/1/16/1114

29.4.2021

30.4.2021

Benlysta

| GlaxoSmithKline (Ireland) Limited |
| --- |
| 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/11/700

4.5.2021

30.4.2021

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

4.5.2021

30.4.2021

Dasselta

| 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/1/11/739

4.5.2021

30.4.2021

Desloratadin Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/732

3.5.2021

30.4.2021

Jardiance

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

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

4.5.2021

30.4.2021

Kigabeq

| ORPHELIA Pharma SAS |
| --- |
| 85 boulevard Saint-Michel, 75005 Paris, France |

ORPHELIA Pharma SAS

85 boulevard Saint-Michel, 75005 Paris, France

EU/1/18/1302

4.5.2021

30.4.2021

Mylotarg

| 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/1/18/1277

4.5.2021

30.4.2021

NULOJIX

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/11/694

4.5.2021

30.4.2021

Remsima

| 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/1/13/853

3.5.2021

30.4.2021

Sprycel

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/06/363

4.5.2021

30.4.2021

Strimvelis

| Orchard Therapeutics (Netherlands) B.V. |
| --- |
| Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland |

Orchard Therapeutics (Netherlands) B.V.

Prins Bernhardplein 200, 1097 JB, Noord-Holland, Amsterdam, Nederland

EU/1/16/1097

4.5.2021

30.4.2021

Tecentriq

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

Roche Registration GmbH

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

EU/1/17/1220

3.5.2021

30.4.2021

Xtandi

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

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/13/846

3.5.2021

—   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 |
| --- | --- | --- | --- | --- |
| 21.4.2021 | PegIntron | Merck Sharp & Dohme B.V. |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

21.4.2021

PegIntron

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/131

26.4.2021

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.4.2021 | Credelio Plus | lotilaner / milbemicin oksim | Elanco GmbH |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, 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

14.4.2021

Credelio Plus

lotilaner / milbemicin oksim

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/21/271

Žvečljive tablete

QP54AB51

15.4.2021

20.4.2021

Ultifend ND IBD

Virus atipične kokošje kuge, virus bolezni Gumboro in virus Marekove bolezni (živ rekombinantni)

| Ceva-Phylaxia Co. Ltd. |
| --- |
| Szállás u. 5, 1107 Budapest, Magyarország |

Ceva-Phylaxia Co. Ltd.

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/21/272

Koncentrat in vehikel za suspenzijo za injiciranje

Pending

22.4.2021

—   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 |
| --- | --- | --- | --- | --- |
| 14.4.2021 | Suprelorin | VIRBAC S.A. |
| 1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

14.4.2021

Suprelorin

VIRBAC S.A.

1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France

EU/2/07/072

19.4.2021

20.4.2021

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

27.4.2021

20.4.2021

Cortavance

| VIRBAC S.A. |
| --- |
| 1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France |

VIRBAC S.A.

1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France

EU/2/06/069

26.4.2021

20.4.2021

Proteq West Nile

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

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/11/129

4.5.2021

20.4.2021

Sevohale

| Chanelle Pharmaceuticals Manufacturing Limited |
| --- |
| Loughrea, Co. Galway, Ireland |

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/16/196

28.4.2021

20.4.2021

Zactran

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/08/082

22.4.2021

26.4.2021

Coliprotec F4/F18

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/16/202

30.4.2021

26.4.2021

Credelio

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland |

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/206

28.4.2021

26.4.2021

Emdocam

| Emdoka bvba |
| --- |
| J. Lijsenstraat 16, 2321 Hoogstraten, België |

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/11/128

27.4.2021

26.4.2021

Enteroporc Coli

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/268

28.4.2021

26.4.2021

Neptra

| Bayer Animal Health GmbH |
| --- |
| D-51368 Leverkusen, Deutschland |

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/19/246

6.5.2021

26.4.2021

Stelfonta

| QBiotics Netherlands B.V. |
| --- |
| Prinses Margrietplantsoen 33, 2595 AM Den Haag, Nederland |

QBiotics Netherlands B.V.

Prinses Margrietplantsoen 33, 2595 AM Den Haag, Nederland

EU/2/19/248

27.4.2021

26.4.2021

Trocoxil

| 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/2/08/084

27.4.2021

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

| Evropska agencija za zdravila |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NIZOZEMSKA |

Evropska agencija za zdravila

Domenico Scarlattilaan 6

1083 HS Amsterdam

NIZOZEMSKA

---

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

---

| 28.5.2021 | SL | Uradni list Evropske unije | C 204/10 |
| --- | --- | --- | --- |

28.5.2021

SL

Uradni list Evropske unije

C 204/10

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. aprila 2021 do 30. aprila 2021

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

(2021/C 204/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 21.4.2021 | Varilrix and associated names | Live attenuated varicella virus (OKA strain) | Glej Prilogo | Glej Prilogo | 22.4.2021 |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

21.4.2021

Varilrix and associated names

Live attenuated varicella virus (OKA strain)

Glej Prilogo

Glej Prilogo

22.4.2021

---

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

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

---

PRILOGA

Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah

| Država članica(EU/EEA) | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Avstrija | GlaxoSmithKline Pharma GmbH |
| Euro Plaza, Gebäude I, 4. Stock Wagenseilgasse 3 |
| 1120 Vienna |
| Austria |

Država članica(EU/EEA)

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

GlaxoSmithKline Pharma GmbH

Euro Plaza, Gebäude I, 4. Stock Wagenseilgasse 3

1120 Vienna

Austria

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Belgija

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89 |
| B-1330 Rixensart Belgium |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

B-1330 Rixensart Belgium

VARILRIX

Živ, oslabljen virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Ciper

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89 |
| B-1330 Rixensart Belgium |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

B-1330 Rixensart Belgium

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Češka

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89 |
| B-1330 Rixensart Belgium |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

B-1330 Rixensart Belgium

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Danska

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykær 68 |
| DK-2605 Brøndby Denmark |

GlaxoSmithKline Pharma A/S

Nykær 68

DK-2605 Brøndby Denmark

VARILRIX

Virus varicella-zoster ≥ 2 000  enot, ki tvorijo plak na odmerek

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Estonija

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89 |
| B-1330 Rixensart Belgium |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

B-1330 Rixensart Belgium

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Finska

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals S.A.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Francija

| LABORATOIRE GLAXOSMITHKLINE |
| --- |
| 23, RUE FRANCOIS JACOB |
| 92500 RUEIL MALMAISON |
| France |

LABORATOIRE GLAXOSMITHKLINE

23, RUE FRANCOIS JACOB

92500 RUEIL MALMAISON

France

VARILRIX

Živ, oslabljen virus noric (sev Oka) – ne manj kot 103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Nemčija

| GlaxoSmithKline GmbH & Co. KG |
| --- |
| Prinzregentenplatz 9 |
| Bogenhausen |
| Bayern |
| 81675 München |
| Germany |

GlaxoSmithKline GmbH & Co. KG

Prinzregentenplatz 9

Bogenhausen

Bayern

81675 München

Germany

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba, intramuskularna uporaba

Grčija

| GlaxoSmithKline Single Member A.E.B.E. |
| --- |
| Kifissias avenue 266 |
| 152 32 Halandri, Athens |
| Greece |

GlaxoSmithKline Single Member A.E.B.E.

Kifissias avenue 266

152 32 Halandri, Athens

Greece

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Madžarska

| GlaxoSmithKline Kft. |
| --- |
| 43. Csörsz Street |
| 1124 Budapest |
| Hungary |

GlaxoSmithKline Kft.

43. Csörsz Street

1124 Budapest

Hungary

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Islandija

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68 |
| DK-2605 Broendby |
| Denmark |

GlaxoSmithKline Pharma A/S

Nykaer 68

DK-2605 Broendby

Denmark

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Italija

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals S.A.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

virus noric (Oka sev): ne manj kot 2 000 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Latvija

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

B-1330 Rixensart

Belgium

VARILRIX pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Litva

| GlaxoSmithKline Lietuva UAB |
| --- |
| Ukmergės st. 120 |
| LT-08105 Vilnius |
| Lithuania |

GlaxoSmithKline Lietuva UAB

Ukmergės st. 120

LT-08105 Vilnius

Lithuania

Varilrix milteliai ir tirpiklis injekciniam tirpalui

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Luksemburg

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals S.A.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

Živ, oslabljen virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Malta

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals S.A.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Norveška

| GlaxoSmithKline AS |
| --- |
| Postboks 180, Vinderen |
| 0319 Oslo |
| Norway |

GlaxoSmithKline AS

Postboks 180, Vinderen

0319 Oslo

Norway

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Polska

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals S.A.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

VARILRIX

Ne manj kot 2 000 enot, ki tvorijo plak virusa varicella- zoster (Oka sev) / 0,5 ml

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Portugalska

| SmithKline & French Portuguesa – Produtos Farmacêuticos, Lda. |
| --- |
| Rua Dr. António Loureiro Borges, 3 |
| Arquiparque – Miraflores 1495-131 Algés |
| Portugal |

SmithKline & French Portuguesa – Produtos Farmacêuticos, Lda.

Rua Dr. António Loureiro Borges, 3

Arquiparque – Miraflores 1495-131 Algés

Portugal

VARILRIX

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Romunija

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l’Institut 89 |
| B-1330 Rixensart |
| Belgium |

GlaxoSmithKline Biologicals S.A.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

Varilrix vaccin varicelic viu atenuat, pulbere şi solvent pentru soluţie injectabilă

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak/0,5 ml

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Španija

| GlaxoSmithKline S.A. |
| --- |
| Severo Ochoa, 2 Parque Tecnologico de Madrid Tres Cantos |
| 28760 Madrid |
| Spain |

GlaxoSmithKline S.A.

Severo Ochoa, 2 Parque Tecnologico de Madrid Tres Cantos

28760 Madrid

Spain

VARILRIX 103,3 UFP/0,5 ml polvo y disolvente para solución inyectable

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

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Švedska

| GlaxoSmithKline AB |
| --- |
| P.O. Box 516 |
| 169 29 Solna |
| Sweden |

GlaxoSmithKline AB

P.O. Box 516

169 29 Solna

Sweden

Varilrix

virus noric (Oka sev) – ≥103.3 enot, ki tvorijo plak

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

Velika Britanija (Severna Irska)

| SmithKline Beecham Ltd trading as GlaxoSmithKline UK |
| --- |
| 980, Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| United Kingdom |

SmithKline Beecham Ltd trading as GlaxoSmithKline UK

980, Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Varilrix 103.3 PFU/0,5  ml, powder and solvent for solution for injection

1 odmerek (0,5 ml) vsebuje: Živ, oslabljen virus varicella zoster (sev Oka) (*1) 103.3 enot, ki tvorijo plak (PFU)

Prašek in vehikel za raztopino za injiciranje

subkutana uporaba

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(*1)  razmnožen na MRC5 humanih diploidnih celicah

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