# Službeni list C 67/26.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 67 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 64.26. veljače 2021. |

ISSN 1977-1088

Službeni list

Europske unije

C 67

Hrvatsko izdanje

Informacije i objave

Godište 64.26. veljače 2021.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2021/C 67/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2020. do 31. prosinca 2020.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2021/C 67/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2021. do 31. siječnja 2021.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 5 |
| 2021/C 67/03 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2021. do 31. siječnja 2021.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 15 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2021/C 67/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2020. do 31. prosinca 2020.(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

2021/C 67/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2021. do 31. siječnja 2021.(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)

5

2021/C 67/03

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2021. do 31. siječnja 2021.(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)

15

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

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 26.2.2021 | HR | Službeni list Europske unije | C 67/1 |
| --- | --- | --- | --- |

26.2.2021

HR

Službeni list Europske unije

C 67/1

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. kolovoza 2020. do 31. prosinca 2020.

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

(2021/C 67/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.12.2020. | Palforzia | odmašćeni prah Arachis hypogaea L., sjeme (kikiriki) | Aimmune Therapeutics Ireland Limited |
| Block B, The Crescent Building, Northwood Crescent Northwood, Dublin 9, D09 C6X8 Ireland |

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

17.12.2020.

Palforzia

odmašćeni prah Arachis hypogaea L., sjeme (kikiriki)

Aimmune Therapeutics Ireland Limited

Block B, The Crescent Building, Northwood Crescent Northwood, Dublin 9, D09 C6X8 Ireland

EU/1/20/1495

Oralni prašak bijele do bež boje u kapsulama za otvaranje ili vrećici.

Pending

21.12.2020.

—   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 |
| --- | --- | --- | --- | --- |
| 3.8.2020. | Urorec | Recordati Ireland Ltd |
| Raheens East, Ringaskiddy Co. Cork, Ireland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

3.8.2020.

Urorec

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/608

14.8.2020.

24.9.2020.

Evoltra

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/06/334

15.10.2020.

24.9.2020.

Luminity

| Lantheus EU Limited |
| --- |
| Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare, V14 FW97, Ireland |

Lantheus EU Limited

Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare, V14 FW97, Ireland

EU/1/06/361

12.10.2020.

24.9.2020.

Matever

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/11/711

25.9.2020.

22.10.2020.

Zavicefta

| Pfizer Ireland Pharmaceuticals |
| --- |
| Operations Support Group, Ringaskiddy, County Cork, Ireland |

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/16/1109

19.11.2020.

27.10.2020.

Fabrazyme

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/01/188

13.11.2020.

27.10.2020.

TRISENOX

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/02/204

29.10.2020.

5.11.2020.

Elaprase

| Shire Human Genetic Therapies AB |
| --- |
| Vasagatan 7, 111 20 Stockholm, Sverige |

Shire Human Genetic Therapies AB

Vasagatan 7, 111 20 Stockholm, Sverige

EU/1/06/365

12.2.2021.

16.11.2020.

Ondexxya

| Alexion Europe SAS |
| --- |
| 103-105 Rue Anatole France, 92300 Levallois-Perret, France |

Alexion Europe SAS

103-105 Rue Anatole France, 92300 Levallois-Perret, France

EU/1/18/1345

4.12.2020.

20.11.2020.

Fampyra

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/11/699

4.12.2020.

20.11.2020.

Humira

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

23.11.2020.

25.11.2020.

Triumeq

| ViiV Healthcare BV |
| --- |
| Huis ter Heideweg 62, 3705 LZ Zeist, Nederland |

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/14/940

7.12.2020.

9.12.2020.

Caprelsa

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/11/749

21.1.2021.

14.12.2020.

Efient

| Daiichi Sankyo Europe GmbH |
| --- |
| Zielstattstraße 48, 81379 München, Deutschland |

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/08/503

16.12.2020.

14.12.2020.

Hulio

| 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/1/18/1319

15.12.2020.

14.12.2020.

Revolade

| 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/1/10/612

13.12.2020.

14.12.2020.

Thyrogen

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/99/122

17.12.2020.

14.12.2020.

Tolucombi

| 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/1/13/821

17.12.2020.

17.12.2020.

Chenodeoxycholic acid Leadiant

| Leadiant GmbH |
| --- |
| Liebherrstr. 22, 80538 Munich, Deutschland |

Leadiant GmbH

Liebherrstr. 22, 80538 Munich, Deutschland

EU/1/16/1110

15.1.2021.

17.12.2020.

Darunavir Krka

| 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/1/17/1249

21.1.2021.

—   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 |
| --- | --- | --- | --- | --- |
| 30.10.2020. | Meloxidolor | Le Vet Beheer B.V. |
| Wilgenweg 7, 3421 TV Oudewater, Nederland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

30.10.2020.

Meloxidolor

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/13/148

3.11.2020.

20.11.2020.

Cepedex

| CP Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13, 31303 Burgdorf, Deutschland |

CP Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/16/200

21.12.2020.

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 |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

---

| 26.2.2021 | HR | Službeni list Europske unije | C 67/5 |
| --- | --- | --- | --- |

26.2.2021

HR

Službeni list Europske unije

C 67/5

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2021. do 31. siječnja 2021.

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

(2021/C 67/02)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.1.2021. | ELZONRIS | tagraksofusp | Stemline Therapeutics B.V. |
| Prins Bernhardplein 200, 1097 JB Amsterdam, Noord-Holland, Nederland |

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

7.1.2021.

ELZONRIS

tagraksofusp

Stemline Therapeutics B.V.

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

EU/1/20/1504

Koncentrat za otopinu za infuziju

L01XX67

13.1.2021.

7.1.2021.

Roclanda

Latanoprosta/netarsudila

| Aerie Pharmaceuticals Ireland Ltd |
| --- |
| Athlone Business and Technology Park, Dublin Road, Garrycastle, Athlone, Co Westmeath, N37 DW40, Ireland |

Aerie Pharmaceuticals Ireland Ltd

Athlone Business and Technology Park, Dublin Road, Garrycastle, Athlone, Co Westmeath, N37 DW40, Ireland

EU/1/20/1502

Kapi za oko, otopina

S01EE51

8.1.2021.

7.1.2021.

Xofluza

baloksavir marboksil

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

Roche Registration GmbH

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

EU/1/20/1500

Filmom obložena tableta

J05AX25

8.1.2021.

11.1.2021.

Onbevzi

bevacizumab

| 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/1/20/1499

Koncentrat za otopinu za infuziju

L01XC07

13.1.2021.

14.1.2021.

Ervebo

Cjepivo protiv Zair Ebolavirusa (rVSVΔG-ZEBOV-GP, živo)

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1392

Otopina za injekciju

J07BX02

19.1.2021.

18.1.2021.

Enhertu

trastuzumab derukstekan

| Daiichi Sankyo Europe GmbH |
| --- |
| Zielstattstraße 48, 81379 München, Deutschland |

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/20/1508

Prašak za koncentrat za otopinu za infuziju

L01XC41

20.1.2021.

—   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 |
| --- | --- | --- | --- | --- |
| 7.1.2021. | Gamifant | Swedish Orphan Biovitrum AB (publ) |
| 112 76 Stockholm, Sverige |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

7.1.2021.

Gamifant

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

—

8.1.2021.

—   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 |
| --- | --- | --- | --- | --- |
| 7.1.2021. | Dukoral | Valneva Sweden AB |
| 105 21 Stockholm, Sverige |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

7.1.2021.

Dukoral

Valneva Sweden AB

105 21 Stockholm, Sverige

EU/1/03/263

8.1.2021.

7.1.2021.

Emgality

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1330

8.1.2021.

7.1.2021.

Holoclar

| Holostem Terapie Avanzate S.r.l. |
| --- |
| Via Glauco Gottardi 100, Modena, MO 41125, Italia |

Holostem Terapie Avanzate S.r.l.

Via Glauco Gottardi 100, Modena, MO 41125, Italia

EU/1/14/987

8.1.2021.

7.1.2021.

Incresync

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

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/842

11.1.2021.

7.1.2021.

Mayzent

| 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/1/19/1414

8.1.2021.

7.1.2021.

Ofev

| 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/1/14/979

8.1.2021.

7.1.2021.

Ondexxya

| Alexion Europe SAS |
| --- |
| 103-105 Rue Anatole France, 92300 Levallois-Perret, France |

Alexion Europe SAS

103-105 Rue Anatole France, 92300 Levallois-Perret, France

EU/1/18/1345

21.1.2021.

7.1.2021.

Temybric Ellipta

| GlaxoSmithKline Trading Services Limited |
| --- |
| Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

EU/1/19/1378

25.1.2021.

7.1.2021.

Truvada

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/04/305

8.1.2021.

7.1.2021.

Vipdomet

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

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/843

12.1.2021.

7.1.2021.

Vipidia

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

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/844

12.1.2021.

7.1.2021.

YERVOY

| 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/1/11/698

10.1.2021.

8.1.2021.

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

8.1.2021.

11.1.2021.

Bydureon

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/11/696

13.1.2021.

11.1.2021.

Byetta

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/06/362

13.1.2021.

11.1.2021.

CRYSVITA

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

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/17/1262

25.1.2021.

11.1.2021.

Dovprela

| 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/1/20/1437

12.1.2021.

11.1.2021.

Dupixent

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Pariz, France

EU/1/17/1229

12.1.2021.

11.1.2021.

Eliquis

| 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/1/11/691

13.1.2021.

11.1.2021.

Esmya

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21., 1103 Budapest, Magyarország |

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750

13.1.2021.

11.1.2021.

HBVAXPRO

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

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/01/183

13.1.2021.

11.1.2021.

Imfinzi

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/18/1322

13.1.2021.

11.1.2021.

Invokana

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/884

12.1.2021.

11.1.2021.

Naglazyme

| BioMarin International Limited |
| --- |
| Shanbally, Ringaskiddy, County Cork P43 R298, Ireland |

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

12.1.2021.

11.1.2021.

Neupro

| 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/1/05/331

25.1.2021.

11.1.2021.

Ocaliva

| Intercept Pharma International Limited |
| --- |
| Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland |

Intercept Pharma International Limited

Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland

EU/1/16/1139

13.1.2021.

11.1.2021.

Ocrevus

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

Roche Registration GmbH

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

EU/1/17/1231

12.1.2021.

11.1.2021.

Pradaxa

| 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/1/08/442

12.1.2021.

11.1.2021.

Silapo

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18, 61118 Bad Vilbel, Deutschland |

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/07/432

12.1.2021.

11.1.2021.

Sirturo

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

12.1.2021.

11.1.2021.

Stelara

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/494

13.1.2021.

11.1.2021.

Tenofovir disoproxil 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/1/16/1129

13.1.2021.

11.1.2021.

Tivicay

| ViiV Healthcare BV |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland |

ViiV Healthcare BV

Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland

EU/1/13/892

13.1.2021.

11.1.2021.

Ulipristal Acetate Gedeon Richter

| Gedeon Richter Plc. |
| --- |
| Gyömrői út 19-21., 1103 Budapest, Magyarország |

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/18/1309

13.1.2021.

11.1.2021.

Zonegran

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

Eisai GmbH

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

EU/1/04/307

13.1.2021.

14.1.2021.

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

21.1.2021.

14.1.2021.

Dovprela

| 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/1/20/1437

15.1.2021.

14.1.2021.

NUCEIVA

| Evolus Pharma Limited |
| --- |
| 70 Sir John Rogerson’s Quay, Dublin 2, Ireland |

Evolus Pharma Limited

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

EU/1/19/1364

15.1.2021.

14.1.2021.

Odefsey

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1112

15.1.2021.

14.1.2021.

Renagel

| Genzyme Europe B.V. |
| --- |
| Paasheuvelweg 25, 1105 BP Amsterdam, Nederland |

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/99/123

21.1.2021.

14.1.2021.

Spinraza

| Biogen Netherlands B.V. |
| --- |
| Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland |

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/17/1188

28.1.2021.

14.1.2021.

Tenofovir disoproxil 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/1/16/1127

16.1.2021.

14.1.2021.

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

15.1.2021.

14.1.2021.

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

15.1.2021.

14.1.2021.

Vokanamet

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/918

18.1.2021.

14.1.2021.

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

15.1.2021.

18.1.2021.

Caelyx pegylated liposomal

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/96/011

19.1.2021.

18.1.2021.

Doptelet

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| 112 76 Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/19/1373

19.1.2021.

18.1.2021.

Hycamtin

| 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/1/96/027

20.1.2021.

21.1.2021.

Bavencio

| Merck Europe B.V. |
| --- |
| Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland |

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

22.1.2021.

21.1.2021.

KEYTRUDA

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

25.1.2021.

21.1.2021.

Lutathera

| Advanced Accelerator Applications |
| --- |
| 20 rue Diesel, 01630 Saint-Genis-Pouilly, France |

Advanced Accelerator Applications

20 rue Diesel, 01630 Saint-Genis-Pouilly, France

EU/1/17/1226

22.1.2021.

21.1.2021.

Mimpara

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/04/292

25.1.2021.

21.1.2021.

Nordimet

| Nordic Group B.V. |
| --- |
| Siriusdreef 41, 2132 WT Hoofddorp, Nederland |

Nordic Group B.V.

Siriusdreef 41, 2132 WT Hoofddorp, Nederland

EU/1/16/1124

30.1.2021.

21.1.2021.

Xarelto

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

22.1.2021.

22.1.2021.

Baraclude

| 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/1/06/343

26.1.2021.

22.1.2021.

Darunavir 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/1/16/1140

1.2.2021.

22.1.2021.

Imraldi

| 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/1/17/1216

26.1.2021.

22.1.2021.

Nplate

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497

25.1.2021.

22.1.2021.

Ribavirin Teva Pharma BV

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/527

26.1.2021.

22.1.2021.

Rinvoq

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/19/1404

25.1.2021.

22.1.2021.

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

25.1.2021.

22.1.2021.

Trazimera

| 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/1/18/1295

25.1.2021.

22.1.2021.

Vizimpro

| 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

25.1.2021.

22.1.2021.

Zinforo

| Pfizer Ireland Pharmaceuticals |
| --- |
| Operations Support Group, Ringaskiddy, County Cork, Ireland |

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

29.1.2021.

22.1.2021.

Zoledronic acid Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/771

27.1.2021.

29.1.2021.

Ambrisentan 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/1/19/1368

2.2.2021.

29.1.2021.

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

1.2.2021.

29.1.2021.

Cubicin

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/328

2.2.2021.

29.1.2021.

Desloratadine Actavis

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/745

1.2.2021.

29.1.2021.

Ganfort

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, County Mayo, Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/06/340

1.2.2021.

29.1.2021.

Iscover

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Pariz, France

EU/1/98/070

1.2.2021.

29.1.2021.

Ivabradine 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/1/16/1144

1.2.2021.

29.1.2021.

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

4.2.2021.

29.1.2021.

Lenalidomide 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/1/18/1316

1.2.2021.

29.1.2021.

Levetiracetam ratiopharm

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland |

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/11/702

1.2.2021.

29.1.2021.

Menveo

| GSK Vaccines S.r.l. |
| --- |
| Via Fiorentina 1, 53100 Siena, Italia |

GSK Vaccines S.r.l.

Via Fiorentina 1, 53100 Siena, Italia

EU/1/10/614

9.2.2021.

29.1.2021.

Neoclarityn

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/161

2.2.2021.

29.1.2021.

Plavix

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Pariz, France

EU/1/98/069

1.2.2021.

29.1.2021.

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

2.2.2021.

29.1.2021.

Zepatier

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/16/1119

2.2.2021.

—   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 |
| --- | --- | --- | --- | --- |
| 11.1.2021. | ViraferonPeg | Merck Sharp & Dohme B.V. |
| Waarderweg 39, 2031 BN Haarlem, Nederland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

11.1.2021.

ViraferonPeg

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/00/132

15.1.2021.

—   Izdavanje odobrenja za stavljanje u promet (članak 38. 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1.2021. | Enteroporc Coli | Cjepivo za neonatalnu prasad protiv kolibaciloze (rekombinantno, inaktivirano) | IDT Biologika GmbH |
| Am Pharmapark, 06861 Dessau-Rosslau, Deutschland |

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

6.1.2021.

Enteroporc Coli

Cjepivo za neonatalnu prasad protiv kolibaciloze (rekombinantno, inaktivirano)

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/20/268

Suspenzija za injekciju

Pending

8.1.2021.

6.1.2021.

NexGard Combo

esafoksolaner/eprinomectin/prazikvantel

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

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/20/267

Otopina za nakapavanje

QP54AA54

7.1.2021.

—   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 |
| --- | --- | --- | --- | --- |
| 14.1.2021. | Profender | Vetoquinol S.A. |
| Magny-Vernois, 70200 Lure, France |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

14.1.2021.

Profender

Vetoquinol S.A.

Magny-Vernois, 70200 Lure, France

EU/2/05/054

15.1.2021.

21.1.2021.

Procox

| VETOQUINOL S.A. |
| --- |
| Magny-Vernois, 70200 Lure, France |

VETOQUINOL S.A.

Magny-Vernois, 70200 Lure, France

EU/2/11/123

22.1.2021.

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 |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

---

| 26.2.2021 | HR | Službeni list Europske unije | C 67/15 |
| --- | --- | --- | --- |

26.2.2021

HR

Službeni list Europske unije

C 67/15

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. siječnja 2021. do 31. siječnja 2021.

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

(2021/C 67/03)

—   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 clanica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 18.1.2021. | Valbazen | Albendazole | Vidjeti Prilog I | Vidjeti Prilog I | 20.1.2021. |
| 11.1.2021. | ulipristal acetate 5 mg | ulipristal acetate 5 mg | Vidjeti Prilog II | Vidjeti Prilog II | 12.1.2021. |

Datum odluke

Naziv(i) lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država clanica na koju se odnosi

Datum obavijesti

18.1.2021.

Valbazen

Albendazole

Vidjeti Prilog I

Vidjeti Prilog I

20.1.2021.

11.1.2021.

ulipristal acetate 5 mg

ulipristal acetate 5 mg

Vidjeti Prilog II

Vidjeti Prilog II

12.1.2021.

---

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

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

---

PRILOG I.

Popis naziva, farmaceutskih oblika, jačine veterinarsko-medicinskih proizvoda, životinjskih vrsta, putova primjene, nositelja odobrenja za stavljanje veterinarsko-medicinskih proizvoda u promet u državama članicama

| Država članica EU-a/EGP-a | Nositelji odobrenja za stavljanje VMP-a u promet | Naziv | INN | Jačina | Farmaceutski oblik | Životinjska vrsta | Put primjene |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austrija | Zoetis Österreich GmbH |
| Floridsdorfer Hauptstraße 1 |
| A- 1210 Wien |
| Österreich |

Država članica EU-a/EGP-a

Nositelji odobrenja za stavljanje VMP-a u promet

Naziv

INN

Jačina

Farmaceutski oblik

Životinjska vrsta

Put primjene

Austrija

Zoetis Österreich GmbH

Floridsdorfer Hauptstraße 1

A- 1210 Wien

Österreich

Valbazen 100 mg/ml-Suspension zum Eingeben für Rinder

albendazol

100 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Austrija

| AniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

AniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Albendazol-aniMedica 100 mg/ml Suspension zum Eingeben für Rinder

albendazol

100 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Austrija

| Chanelle Pharmaceuticals Manufacturing Ltd |
| --- |
| IDA Industrial Estate |
| Dublin Road, Loughrea |
| Co Galway H62 H771 |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd

IDA Industrial Estate

Dublin Road, Loughrea

Co Galway H62 H771

Ireland

Albex Gold 200 mg/ml Oral Suspension for Cattle

albendazol

200 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Belgija

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straβe 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straβe 4

27472 Cuxhaven

Germany

Valbazen 10 %

albendazol

100 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Belgija

| Chanelle Pharmaceuticals Manufacturing Ltd |
| --- |
| IDA Industrial Estate |
| Dublin Road, Loughrea |
| Co Galway H62 H771 |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd

IDA Industrial Estate

Dublin Road, Loughrea

Co Galway H62 H771

Ireland

Albex 200 mg/ml oral suspension for cattle

albendazol

200 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Bugarska

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Gardal 10 %

albendazol

100 mg/ml

Oralna suspenzija

Goveda, ovce

Peroralna primjena

Bugarska

| Asklep-Pharma Ltd., |
| --- |
| Lyulin 7, bl. 711 A, shop 3, |
| Bulgaria |

Asklep-Pharma Ltd.,

Lyulin 7, bl. 711 A, shop 3,

Bulgaria

Albex BG 100 mg/ml oral suspension for cattle and sheep

albendazol

100 mg/ml

Oralna suspenzija

Goveda, ovce

Peroralna primjena

Hrvatska

| Mount Trade d.o.o., Industrijska cesta 13, 43280 Garešnica |
| --- |
| Croatia |

Mount Trade d.o.o., Industrijska cesta 13, 43280 Garešnica

Croatia

Albix 100 mg/ml, oralna suspenzija za goveda i ovce

albendazol

100 mg/ml

Oralna suspenzija

Goveda, ovce

Peroralna primjena

Francuska

| Zoetis France |
| --- |
| 10 Rue Raymond David |
| 92240 Malakoff |
| France |

Zoetis France

10 Rue Raymond David

92240 Malakoff

France

Valbazen dix

albendazol

100 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Francuska

| Chanelle Pharmaceuticals Manufacturing Ltd |
| --- |
| IDA Industrial Estate |
| Dublin Road, Loughrea |
| Co Galway H62 H771 |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd

IDA Industrial Estate

Dublin Road, Loughrea

Co Galway H62 H771

Ireland

Albex Gold 200 mg/ml suspension buvable pour bovins

albendazol

200 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Njemačka

| Lilly Deutschland GmbH Abteilung Elanco Animal Health |
| --- |
| Werner-Reimers-Straße 2-4 |
| 61352 Bad Homburg |
| Germany |

Lilly Deutschland GmbH Abteilung Elanco Animal Health

Werner-Reimers-Straße 2-4

61352 Bad Homburg

Germany

Valbazen 10 %

albendazol

100 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Njemačka

| Chanelle Pharmaceuticals Manufacturing Ltd |
| --- |
| IDA Industrial Estate |
| Dublin Road, Loughrea |
| Co Galway H62 H771 |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd

IDA Industrial Estate

Dublin Road, Loughrea

Co Galway H62 H771

Ireland

Albex Gold 200 mg/ml Oral Suspension for Cattle

albendazol

200 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Grčka

| Provet S.A. |
| --- |
| 77, Posidonos Avenue |
| 174 55 Alimos, Attiki |
| Greece |

Provet S.A.

77, Posidonos Avenue

174 55 Alimos, Attiki

Greece

Albendazole/Provet, πόσιμο εναιώρημα 10 % w/v

albendazol

100 mg/ml

Oralna suspenzija

Telad, ovce, koze

Peroralna primjena

Grčka

| Chanelle Pharmaceuticals Manufacturing Ltd |
| --- |
| IDA Industrial Estate |
| Dublin Road, Loughrea |
| Co Galway H62 H771 |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd

IDA Industrial Estate

Dublin Road, Loughrea

Co Galway H62 H771

Ireland

Albex Πόσιμο εναιώρημα 10 % w/v/

albendazol

100 mg/ml

Oralna suspenzija

Goveda, ovce, koze

Peroralna primjena

Irska

| Zoetis Belgium S.A. |
| --- |
| 2nd Floor, Building 10, Cherrywood Business Park, Loughlinstown, Co Dublin, Ireland |

Zoetis Belgium S.A.

2nd Floor, Building 10, Cherrywood Business Park, Loughlinstown, Co Dublin, Ireland

Valbazen 100 mg/ml Total Spectrum Wormer

albendazol

100 mg/ml

Oralna suspenzija

Goveda, ovce

Peroralna primjena

Irska

| Chanelle Pharmaceuticals Manufacturing Ltd |
| --- |
| IDA Industrial Estate |
| Dublin Road, Loughrea |
| Co Galway H62 H771 |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd

IDA Industrial Estate

Dublin Road, Loughrea

Co Galway H62 H771

Ireland

Albex Gold 200 mg/ml oral suspension for cattle

albendazol

200 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Italija

| Zoetis Italia S.r.l. |
| --- |
| Via Andrea Doria 41M |
| 00192 Roma |
| Italy |

Zoetis Italia S.r.l.

Via Andrea Doria 41M

00192 Roma

Italy

Valbazen 100 mg/ml sospensione per uso orale per bovini ed ovini

albendazol

100 mg/ml

Oralna suspenzija

Goveda, ovce

Peroralna primjena

Italija

| Fatro S.p.A. |
| --- |
| Via Emilia, 285 |
| 40064 Ozzano dell’Emilia (Bologna) |
| Italy |

Fatro S.p.A.

Via Emilia, 285

40064 Ozzano dell’Emilia (Bologna)

Italy

Sverminator 10, 100 mg/ml, sospensione orale per bovini ed ovini

albendazol

100 mg/ml

Oralna suspenzija

Goveda, ovce

Peroralna primjena

Italija

| Chanelle Pharmaceuticals Manufacturing Ltd |
| --- |
| IDA Industrial Estate |
| Dublin Road, Loughrea |
| Co Galway H62 H771 |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd

IDA Industrial Estate

Dublin Road, Loughrea

Co Galway H62 H771

Ireland

Albex Gold 200 mg/ml sospensione orale per bovini

albendazol

200 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Luksemburg

| Elanco GmbH |
| --- |
| Heinz-Lohmann-Straβe 4 |
| 27472 Cuxhaven |
| Germany |

Elanco GmbH

Heinz-Lohmann-Straβe 4

27472 Cuxhaven

Germany

Valbazen 10 %

albendazol

100 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Malta

| Fatro S.p.A. |
| --- |
| Via Emilia, 285 |
| 40064 Ozzano dell’Emilia (Bologna) |
| Italy |

Fatro S.p.A.

Via Emilia, 285

40064 Ozzano dell’Emilia (Bologna)

Italy

Sverminator 10

albendazol

100 mg/ml

Oralna suspenzija

Goveda, ovce

Peroralna primjena

Poljska

| Chanelle Pharmaceuticals Manufacturing Ltd |
| --- |
| IDA Industrial Estate |
| Dublin Road, Loughrea |
| Co Galway H62 H771 |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd

IDA Industrial Estate

Dublin Road, Loughrea

Co Galway H62 H771

Ireland

Albex Gold 200 mg/ml oral suspension for cattle

albendazol

200 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Poljska

| ZoetisPolska Sp. z.o.o |
| --- |
| Postępu 17B, 02-676 Warszawa |
| Poland |

ZoetisPolska Sp. z.o.o

Postępu 17B, 02-676 Warszawa

Poland

Valbazen 10 %, 10 g/100 ml zawiesina doustna dla bydla i owiec

albendazol

100 mg/ml

Oralna suspenzija

Goveda, ovce

Peroralna primjena

Poljska

| C&H Generics Limited |
| --- |
| c/o Michael McEvoy and Co |
| Seville House |
| New Dock Street |
| H91CKV0 Galway |
| Ireland |

C&H Generics Limited

c/o Michael McEvoy and Co

Seville House

New Dock Street

H91CKV0 Galway

Ireland

Albex 10 %

albendazol

100 mg/ml

Oralna suspenzija

Goveda, ovce

Peroralna primjena

Rumunjska

| Crida Pharm S.R.L., |
| --- |
| Str. Intrarea Vagonetului, Nr.2 |
| Bl 101, Ap. 47, Sector 6, |
| RO-061151 Bucharest, |
| Romania |

Crida Pharm S.R.L.,

Str. Intrarea Vagonetului, Nr.2

Bl 101, Ap. 47, Sector 6,

RO-061151 Bucharest,

Romania

Cribendazol 10 %, 100 mg/ml

albendazol

100 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

Nizozemska

| Chanelle Pharmaceuticals Manufacturing Ltd |
| --- |
| IDA Industrial Estate |
| Dublin Road, Loughrea |
| Co Galway H62 H771 |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd

IDA Industrial Estate

Dublin Road, Loughrea

Co Galway H62 H771

Ireland

Albex Gold 200 mg/ml, orale suspensie voor runderen

albendazol

200 mg/ml

Oralna suspenzija

Goveda

Peroralna primjena

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PRILOG II.

Popis nacionalno odobrenih lijekova

| Država članica (EGP) | Nositelj odobrenja za stavljanje lijeka u promet | Naziv lijeka | INN/Djelatna tvar + jačina (po jedinici doze) | Farmaceutski oblik | Put primjene |
| --- | --- | --- | --- | --- | --- |
| Hrvatska | Alvogen Pharma Trading Europe Eood | Ulipristalacetat Alvogen | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Češka | Aristo Pharma Gmbh (Art 57) | Ulimyo | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Češka | Zentiva, K.S. | Stillupra | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Francuska | Accord Healthcare France Sas | Ulipristal Acetate Accord | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Francuska | Eg Labo Laboratoires Eurogenerics | Ulipristal Acetate Eg | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Francuska | Helm Ag | Ulipristal Acetate Helm | ulipristalacetat, tableta od 5 mg | filmom obložena tableta | peroralno |
| Francuska | Zentiva France | Ulipristal Acetate Zentiva | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Njemačka | Accord Healthcare B.V. | Ulipristal Accord | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Njemačka | Aliud Pharma Gmbh | Ulipristal Al | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Njemačka | Aristo Pharma Gmbh (Art 57) | Ulimyo | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Njemačka | Cipla Europe Nv | Ulipristal Cipla | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Njemačka | Cyndea Pharma S.L | Ulipristal Cyndea | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Njemačka | Heumann Pharma Gmbh & Co. Generica Kg | Ulipristal Heumann | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Njemačka | Zentiva Pharma Gmbh | Ulipristal Zentiva | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Grčka | Faran S.A. | Boled | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Mađarska | Alvogen Pharma Trading Europe Eood | Uliprisztál-Acetát Alvogen | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Mađarska | Aristo Pharma Gmbh (Art 57) | Ulimyo | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Island | Alvogen Pharma Trading Europe Eood | Ulipristal Asetat Alvogen | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Malta | G.L. Pharma Gmbh | Ulipristal G.L. | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Nizozemska | Helm Ag | Ulipristal Helm | ulipristalacetat, tableta od 5 mg | filmom obložena tableta | peroralno |
| Nizozemska | Sandoz B.V. | Elyoma | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Poljska | Alvogen Pharma Trading Europe Eood | Ulipristal Alvogen | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Poljska | Aristo Pharma Gmbh (Art 57) | Ulimyo | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Portugal | Ciclum Farma Unipessoal Lda. | Ulipristal Ciclum | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Portugal | G.L. Pharma Gmbh | Ulipristal G.L | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Portugal | Sumar Pharma Ehf | Karevonal | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Portugal | Sumar Pharma Ehf | Selavona | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Portugal | Sumar Pharma Ehf | Ulipristal Sumar | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Portugal | Sumar Pharma Ehf | Varinam | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Portugal | Zentiva Portugal, Lda | Stillupra | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Portugal | Zentiva Portugal, Lda | Ulipristal Zentiva | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Slovačka | Aristo Pharma Gmbh (Art 57) | Ulimyo | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Slovačka | Zentiva, K.S. | Stillupra | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Španjolska | Adamed Laboratorios, S.L.U. | Missitel | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Španjolska | Cipla Europe Nv | Ulipristal Cipla | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Španjolska | Cyndea Pharma S.L | Ulipristal Cyndea | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Španjolska | Helm Ag | Ulipristal Acetate Helm | ulipristalacetat, tableta od 5 mg | filmom obložena tableta | peroralno |
| Ujedinjena Kraljevina | Accord Healthcare Limited | Ulipristal Acetate Accord Healthcare | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Ujedinjena Kraljevina | Cipla (Eu) Limited | Ulipristal Acetate Cipla | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Ujedinjena Kraljevina | Creo Pharma Ltd | Ulipristal Acetate Creo Pharma | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Ujedinjena Kraljevina | Helm Ag | Ulipristal Helm | ulipristalacetat, tableta od 5 mg | filmom obložena tableta | peroralno |
| Ujedinjena Kraljevina | Mercury Pharmaceuticals Ltd. | Ulipristal Acetate Mercury Pharmaceuticals | ulipristalacetat, tableta od 5 mg | tableta | peroralno |
| Ujedinjena Kraljevina | Zentiva Pharma Uk Limited | Ulipristal Acetate Zentiva | ulipristalacetat, tableta od 5 mg | tableta | peroralno |

Država članica (EGP)

Nositelj odobrenja za stavljanje lijeka u promet

Naziv lijeka

INN/Djelatna tvar + jačina (po jedinici doze)

Farmaceutski oblik

Put primjene

Hrvatska

Alvogen Pharma Trading Europe Eood

Ulipristalacetat Alvogen

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Češka

Aristo Pharma Gmbh (Art 57)

Ulimyo

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Češka

Zentiva, K.S.

Stillupra

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Francuska

Accord Healthcare France Sas

Ulipristal Acetate Accord

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Francuska

Eg Labo Laboratoires Eurogenerics

Ulipristal Acetate Eg

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Francuska

Helm Ag

Ulipristal Acetate Helm

ulipristalacetat, tableta od 5 mg

filmom obložena tableta

peroralno

Francuska

Zentiva France

Ulipristal Acetate Zentiva

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Njemačka

Accord Healthcare B.V.

Ulipristal Accord

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Njemačka

Aliud Pharma Gmbh

Ulipristal Al

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Njemačka

Aristo Pharma Gmbh (Art 57)

Ulimyo

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Njemačka

Cipla Europe Nv

Ulipristal Cipla

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Njemačka

Cyndea Pharma S.L

Ulipristal Cyndea

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Njemačka

Heumann Pharma Gmbh & Co. Generica Kg

Ulipristal Heumann

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Njemačka

Zentiva Pharma Gmbh

Ulipristal Zentiva

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Grčka

Faran S.A.

Boled

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Mađarska

Alvogen Pharma Trading Europe Eood

Uliprisztál-Acetát Alvogen

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Mađarska

Aristo Pharma Gmbh (Art 57)

Ulimyo

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Island

Alvogen Pharma Trading Europe Eood

Ulipristal Asetat Alvogen

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Malta

G.L. Pharma Gmbh

Ulipristal G.L.

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Nizozemska

Helm Ag

Ulipristal Helm

ulipristalacetat, tableta od 5 mg

filmom obložena tableta

peroralno

Nizozemska

Sandoz B.V.

Elyoma

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Poljska

Alvogen Pharma Trading Europe Eood

Ulipristal Alvogen

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Poljska

Aristo Pharma Gmbh (Art 57)

Ulimyo

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Portugal

Ciclum Farma Unipessoal Lda.

Ulipristal Ciclum

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Portugal

G.L. Pharma Gmbh

Ulipristal G.L

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Portugal

Sumar Pharma Ehf

Karevonal

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Portugal

Sumar Pharma Ehf

Selavona

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Portugal

Sumar Pharma Ehf

Ulipristal Sumar

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Portugal

Sumar Pharma Ehf

Varinam

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Portugal

Zentiva Portugal, Lda

Stillupra

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Portugal

Zentiva Portugal, Lda

Ulipristal Zentiva

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Slovačka

Aristo Pharma Gmbh (Art 57)

Ulimyo

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Slovačka

Zentiva, K.S.

Stillupra

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Španjolska

Adamed Laboratorios, S.L.U.

Missitel

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Španjolska

Cipla Europe Nv

Ulipristal Cipla

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Španjolska

Cyndea Pharma S.L

Ulipristal Cyndea

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Španjolska

Helm Ag

Ulipristal Acetate Helm

ulipristalacetat, tableta od 5 mg

filmom obložena tableta

peroralno

Ujedinjena Kraljevina

Accord Healthcare Limited

Ulipristal Acetate Accord Healthcare

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Ujedinjena Kraljevina

Cipla (Eu) Limited

Ulipristal Acetate Cipla

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Ujedinjena Kraljevina

Creo Pharma Ltd

Ulipristal Acetate Creo Pharma

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Ujedinjena Kraljevina

Helm Ag

Ulipristal Helm

ulipristalacetat, tableta od 5 mg

filmom obložena tableta

peroralno

Ujedinjena Kraljevina

Mercury Pharmaceuticals Ltd.

Ulipristal Acetate Mercury Pharmaceuticals

ulipristalacetat, tableta od 5 mg

tableta

peroralno

Ujedinjena Kraljevina

Zentiva Pharma Uk Limited

Ulipristal Acetate Zentiva

ulipristalacetat, tableta od 5 mg

tableta

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