# Službeni list C 105/26.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 105 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 64.26. ožujka 2021. |

ISSN 1977-1088

Službeni list

Europske unije

C 105

Hrvatsko izdanje

Informacije i objave

Godište 64.26. ožujka 2021.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2021/C 105/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2021. do 28. veljače 2021.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2021/C 105/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2021. do 28. veljače 2021.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EZ ili člankom 38. Direktive 2001/82/EZ) | 11 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2021/C 105/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2021. do 28. veljače 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)

1

2021/C 105/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2021. do 28. veljače 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)

11

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

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 26.3.2021 | HR | Službeni list Europske unije | C 105/1 |
| --- | --- | --- | --- |

26.3.2021

HR

Službeni list Europske unije

C 105/1

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2021. do 28. veljače 2021.

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

(2021/C 105/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.2.2021. | Rukobia | fostemsavir | ViiV Healthcare BV |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, 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

4.2.2021.

Rukobia

fostemsavir

ViiV Healthcare BV

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

EU/1/20/1518

Tablete s produženim oslobađanjem

J05AX29

5.2.2021.

5.2.2021.

Kixelle

inzulin aspart

| 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/1/20/1506

Otopina za injekciju

A10AB05

8.2.2021.

8.2.2021.

Inrebic

fedratinib

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

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/20/1514

Kapsula, tvrda

L01XE57

9.2.2021.

8.2.2021.

Lumoxiti

moksetumomab pasudotoks

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/20/1522

Prašak za koncentrat i otopina za otopinu za infuziju

L01XC34

9.2.2021.

11.2.2021.

Lenalidomide Krka

lenalidomid

| 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/1/20/1520

Kapsula, tvrda

L04AX04

15.2.2021.

11.2.2021.

Lenalidomide Krka d.d.

lenalidomid

| 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/1/20/1521

Kapsula, tvrda

L04AX04

2.3.2021.

11.2.2021.

Lenalidomide Krka d.d. Novo mesto

lenalidomid

| 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/1/20/1519

Kapsula, tvrda

L04AX04

12.2.2021.

11.2.2021.

Ogluo

glukagon

| Xeris Pharmaceuticals Ireland Limited |
| --- |
| 8th Floor Block East, Iveagh Court, Harcourt Road, Dublin 2, Ireland |

Xeris Pharmaceuticals Ireland Limited

8th Floor Block East, Iveagh Court, Harcourt Road, Dublin 2, Ireland

EU/1/20/1523

Otopina za injekciju u napunjenoj brizgalici

Otopina za injekciju u napunjenoj štrcaljki

H04AA01

17.2.2021.

11.2.2021.

Retsevmo

selperkatinib

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

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/20/1527

Kapsula, tvrda

L01EX22

12.2.2021.

11.2.2021.

Sunitinib Accord

sunitinib

| 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/1/20/1511

Kapsula, tvrda

L01XE04

12.2.2021.

11.2.2021.

TUKYSA

tukatinib

| Seagen B.V. |
| --- |
| Evert van de Beekstraat 1-140, 1118CL Schiphol, Nederland |

Seagen B.V.

Evert van de Beekstraat 1-140, 1118CL Schiphol, Nederland

EU/1/20/1526

Filmom obložena tableta

L01EH03

12.2.2021.

11.2.2021.

Yuflyma

adalimumaba

| 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/1/20/1513

Otopina za injekciju

L04AB04

12.2.2021.

18.2.2021.

Heplisav B

površinski antigen virusa hepatitisa B

| Dynavax GmbH |
| --- |
| Eichsfelder Strasse 11, D-40595 Düsseldorf, Deutschland |

Dynavax GmbH

Eichsfelder Strasse 11, D-40595 Düsseldorf, Deutschland

EU/1/20/1503

Otopina za injekciju

J07BC01

19.2.2021.

—   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 |
| --- | --- | --- | --- | --- |
| 1.2.2021. | Rizmoic | Shionogi B.V. |
| Kingsfordweg 151, 1043 GR Amsterdam, Nederland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

1.2.2021.

Rizmoic

Shionogi B.V.

Kingsfordweg 151, 1043 GR Amsterdam, Nederland

EU/1/18/1291

11.2.2021.

1.2.2021.

Rotarix

| 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/1/05/330

4.2.2021.

2.2.2021.

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

2.2.2021.

4.2.2021.

Clopidogrel ratiopharm

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/975

8.2.2021.

4.2.2021.

Gazyvaro

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

Roche Registration GmbH

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

EU/1/14/937

10.2.2021.

4.2.2021.

HALAVEN

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

Eisai GmbH

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

EU/1/11/678

5.2.2021.

4.2.2021.

IDELVION

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland |

CSL Behring GmbH

Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland

EU/1/16/1095

5.2.2021.

4.2.2021.

Juluca

| ViiV Healthcare B.V. |
| --- |
| Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands |

ViiV Healthcare B.V.

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

EU/1/18/1282

5.2.2021.

4.2.2021.

Kuvan

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

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

5.2.2021.

4.2.2021.

Mycamine

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

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/08/448

10.2.2021.

4.2.2021.

Reblozyl

| 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/1/20/1452

8.2.2021.

4.2.2021.

Spravato

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/19/1410

5.2.2021.

4.2.2021.

Sycrest

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

Organon N.V.

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/10/640

23.2.2021.

4.2.2021.

TOOKAD

| Steba Biotech S.A |
| --- |
| 7 Place du Théâtre, 2613 Luxembourg, Luxembourg |

Steba Biotech S.A

7 Place du Théâtre, 2613 Luxembourg, Luxembourg

EU/1/17/1228

5.2.2021.

4.2.2021.

VEYVONDI

| Baxalta Innovations GmbH |
| --- |
| Industriestraße 67, 1221 Wien, Österreich |

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/18/1298

5.2.2021.

4.2.2021.

Waylivra

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

Akcea Therapeutics Ireland Limited

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

EU/1/19/1360

8.2.2021.

4.2.2021.

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

10.2.2021.

8.2.2021.

Clopidogrel BGR

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

Laboratoires BIOGARAN

15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France

EU/1/09/558

16.2.2021.

8.2.2021.

EndolucinBeta

| ITM Medical Isotopes GmbH |
| --- |
| Lichtenbergstraße 1, 85748 Garching, Deutschland |

ITM Medical Isotopes GmbH

Lichtenbergstraße 1, 85748 Garching, Deutschland

EU/1/16/1105

9.2.2021.

8.2.2021.

Zavesca

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/238

9.2.2021.

11.2.2021.

ALPROLIX

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

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/16/1098

12.2.2021.

11.2.2021.

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

12.2.2021.

11.2.2021.

Bosulif

| 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/1/13/818

12.2.2021.

11.2.2021.

Clopidogrel Taw Pharma

| Taw Pharma (Ireland) Limited |
| --- |
| 104 Lower Baggot Street, Dublin 2, Ireland |

Taw Pharma (Ireland) Limited

104 Lower Baggot Street, Dublin 2, Ireland

EU/1/09/568

26.2.2021.

11.2.2021.

Cometriq

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

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

9.3.2021.

11.2.2021.

Descovy

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

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1099

17.2.2021.

11.2.2021.

Galafold

| Amicus Therapeutics Europe Limited |
| --- |
| Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland |

Amicus Therapeutics Europe Limited

Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland

EU/1/15/1082

12.2.2021.

11.2.2021.

Neparvis

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

Novartis Europharm Limited

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

EU/1/16/1103

12.2.2021.

11.2.2021.

Omnitrope

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/06/332

15.2.2021.

11.2.2021.

Xerava

| Tetraphase Pharmaceuticals Ireland Limited |
| --- |
| 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland |

Tetraphase Pharmaceuticals Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/18/1312

22.2.2021.

11.2.2021.

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

12.2.2021.

12.2.2021.

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

23.2.2021.

12.2.2021.

Clopidogrel Taw Pharma

| Taw Pharma (Ireland) Limited |
| --- |
| 104 Lower Baggot Street, Dublin 2, Ireland |

Taw Pharma (Ireland) Limited

104 Lower Baggot Street, Dublin 2, Ireland

EU/1/09/568

25.2.2021.

12.2.2021.

Copalia

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

Novartis Europharm Limited

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

EU/1/06/372

15.2.2021.

12.2.2021.

Dafiro

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

Novartis Europharm Limited

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

EU/1/06/371

15.2.2021.

12.2.2021.

Exforge HCT

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

Novartis Europharm Limited

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

EU/1/09/569

15.2.2021.

12.2.2021.

Karvea

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/97/049

15.2.2021.

12.2.2021.

Karvezide

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/085

15.2.2021.

12.2.2021.

Palonosetron 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/1/16/1104

15.2.2021.

17.2.2021.

Opsumit

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/893

18.2.2021.

18.2.2021.

Bortezomib 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/1/15/1019

22.2.2021.

18.2.2021.

Bortezomib 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/1/19/1397

22.2.2021.

18.2.2021.

Bortezomib SUN

| Sun Pharmaceutical Industries Europe BV |
| --- |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland |

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/16/1102

22.2.2021.

18.2.2021.

CellCept

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

Roche Registration GmbH

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

EU/1/96/005

19.2.2021.

18.2.2021.

Emselex

| zr pharma& GmbH |
| --- |
| Hietzinger Hauptstrasse 37, 1130 Wien, Österreich |

zr pharma& GmbH

Hietzinger Hauptstrasse 37, 1130 Wien, Österreich

EU/1/04/294

26.2.2021.

18.2.2021.

Ifirmacombi

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

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/673

22.2.2021.

18.2.2021.

Mabthera

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

Roche Registration GmbH

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

EU/1/98/067

19.2.2021.

18.2.2021.

Myclausen

| Passauer Pharma GmbH |
| --- |
| Eiderstedter Weg 3, 14129 Berlin, Deutschland |

Passauer Pharma GmbH

Eiderstedter Weg 3, 14129 Berlin, Deutschland

EU/1/10/647

22.2.2021.

18.2.2021.

Nimenrix

| 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/1/12/767

19.2.2021.

18.2.2021.

NutropinAq

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

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/00/164

19.2.2021.

18.2.2021.

Ongentys

| Bial – Portela & Ca, SA |
| --- |
| À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal |

Bial – Portela & Ca, SA

À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal

EU/1/15/1066

19.2.2021.

18.2.2021.

VELCADE

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/04/274

19.2.2021.

19.2.2021.

Aprovel

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/97/046

24.2.2021.

19.2.2021.

CoAprovel

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

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/98/086

24.2.2021.

19.2.2021.

Copalia HCT

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

Novartis Europharm Limited

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

EU/1/09/575

22.2.2021.

19.2.2021.

Dafiro HCT

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

Novartis Europharm Limited

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

EU/1/09/574

22.2.2021.

19.2.2021.

Entresto

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

Novartis Europharm Limited

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

EU/1/15/1058

23.2.2021.

19.2.2021.

Envarsus

| 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/1/14/935

23.2.2021.

19.2.2021.

Exforge

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

Novartis Europharm Limited

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

EU/1/06/370

22.2.2021.

19.2.2021.

Hefiya

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

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

22.2.2021.

19.2.2021.

Ifirmasta

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

KRKA d d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/480

2.3.2021.

19.2.2021.

INOmax

| Linde Healthcare AB |
| --- |
| SE-181 81 Lidingö, Sverige |

Linde Healthcare AB

SE-181 81 Lidingö, Sverige

EU/1/01/194

23.2.2021.

19.2.2021.

Irbesartan HCT Zentiva

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

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/377

22.2.2021.

19.2.2021.

Irbesartan / Hydrochlorothiazide Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

22.2.2021.

19.2.2021.

Irbesartan Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/576

1.3.2021.

19.2.2021.

Irbesartan Zentiva

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

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/376

22.2.2021.

19.2.2021.

Mycophenolate mofetil Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

1.3.2021.

19.2.2021.

Myfenax

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/438

1.3.2021.

19.2.2021.

Neparvis

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

Novartis Europharm Limited

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

EU/1/16/1103

22.2.2021.

19.2.2021.

Ondexxya

| Alexion Europe S.A.S. |
| --- |
| 103 Rue Anatole France, 92300 Levallois Perret, France |

Alexion Europe S.A.S.

103 Rue Anatole France, 92300 Levallois Perret, France

EU/1/18/1345

24.2.2021.

19.2.2021.

Soliris

| 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/1/07/393

24.2.2021.

19.2.2021.

TAKHZYRO

| 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/1/18/1340

22.2.2021.

19.2.2021.

Tamiflu

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

Roche Registration GmbH

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

EU/1/02/222

22.2.2021.

23.2.2021.

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

23.2.2021.

25.2.2021.

Buccolam

| Laboratorios Lesvi, S.L. |
| --- |
| Avda. Barcelona 69, 08970 Sant Joan Despí – Barcelona, España |

Laboratorios Lesvi, S.L.

Avda. Barcelona 69, 08970 Sant Joan Despí – Barcelona, España

EU/1/11/709

26.2.2021.

25.2.2021.

Clopidogrel/Acetylsalicylic acid 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/1/19/1395

1.3.2021.

26.2.2021.

Pazenir

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

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/18/1317

1.3.2021.

26.2.2021.

Spravato

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

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/19/1410

1.3.2021.

26.2.2021.

Vaxchora

| Emergent Netherlands B.V. |
| --- |
| Strawinskylaan 411, 1077 XX Amsterdam, Nederland |

Emergent Netherlands B.V.

Strawinskylaan 411, 1077 XX Amsterdam, Nederland

EU/1/20/1423

1.3.2021.

—   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 |
| --- | --- | --- | --- | --- |
| 4.2.2021. | Udenyca | ERA Consulting GmbH |
| Lange Straße 70, 29664 Walsrode, Deutschland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.2.2021.

Udenyca

ERA Consulting GmbH

Lange Straße 70, 29664 Walsrode, Deutschland

EU/1/18/1303

5.2.2021.

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.2.2021. | Solensia | frunevetmab | Zoetis Belgium SA |
| Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |

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

17.2.2021.

Solensia

frunevetmab

Zoetis Belgium SA

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

EU/2/20/269

Otopina za injekciju

Pending

18.2.2021.

—   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 |
| --- | --- | --- | --- | --- |
| 1.2.2021. | Meloxoral | Le Vet 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

1.2.2021.

Meloxoral

Le Vet B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/10/111

3.2.2021.

9.2.2021.

BTVPUR

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

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/10/113

18.2.2021.

9.2.2021.

Cerenia

| 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/2/06/062

11.2.2021.

9.2.2021.

Draxxin

| 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/2/03/041

11.2.2021.

9.2.2021.

Emdocam

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

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/11/128

11.2.2021.

9.2.2021.

LETIFEND

| Laboratorios LETI, S.L.unipersonal |
| --- |
| C/ Del Sol 5, Polígono Industrial Norte, Tres Cantos, 28760 Madrid, España |

Laboratorios LETI, S.L.unipersonal

C/ Del Sol 5, Polígono Industrial Norte, Tres Cantos, 28760 Madrid, España

EU/2/16/195

11.2.2021.

9.2.2021.

Nobivac Bb

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

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/02/034

12.2.2021.

9.2.2021.

Porcilis PCV M Hyo

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

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/175

19.2.2021.

9.2.2021.

Reconcile

| Pegasus Laboratories Ireland Limited |
| --- |
| 10 McCurtain Hill, Clonakilty, County Cork, P85 K230, Ireland |

Pegasus Laboratories Ireland Limited

10 McCurtain Hill, Clonakilty, County Cork, P85 K230, Ireland

EU/2/08/080

11.3.2021.

12.2.2021.

Evalon

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

Laboratorios Hipra, S.A.

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

EU/2/16/194

17.2.2021.

12.2.2021.

Halagon

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

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/16/201

15.2.2021.

26.2.2021.

Enteroporc Coli AC

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

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

EU/2/20/262

1.3.2021.

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.

---

| 26.3.2021 | HR | Službeni list Europske unije | C 105/11 |
| --- | --- | --- | --- |

26.3.2021

HR

Službeni list Europske unije

C 105/11

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. veljače 2021. do 28. veljače 2021.

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

(2021/C 105/02)

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

| Datum odluke | Naziv(i) lijeka | INN (međunarodni nezaštićeni naziv lijeka) | Nositelj(i) odobrenja za stavljanje u promet | Država članica na koju se odnosi | Datum obavijesti |
| --- | --- | --- | --- | --- | --- |
| 25.2.2021. | Adjusol tmp sulfa liquide and its associated names | Sulfadiazine and trimethoprim | Vidjeti Prilog | Vidjeti Prilog | 26.2.2021. |
| 19.2.2021. | Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group | candesartan, irbesartan, losartan, olmesartan, valsartan | Nije primjenjivo | Nije primjenjivo | 22.2.2021. |

Datum odluke

Naziv(i) lijeka

INN (međunarodni nezaštićeni naziv lijeka)

Nositelj(i) odobrenja za stavljanje u promet

Država članica na koju se odnosi

Datum obavijesti

25.2.2021.

Adjusol tmp sulfa liquide and its associated names

Sulfadiazine and trimethoprim

Vidjeti Prilog

Vidjeti Prilog

26.2.2021.

19.2.2021.

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

candesartan, irbesartan, losartan, olmesartan, valsartan

Nije primjenjivo

Nije primjenjivo

22.2.2021.

---

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

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

---

PRILOG

Popis nazivâ, farmaceutskog oblika, jačine veterinarsko-medicinskih proizvoda, vrsta životinja, putova primjene, nositelja odobrenja za stavljanje VMP-a u promet u državama članicama

| Država članica EU-a/EGP-a | Nositelj odobrenja za stavljanje VMP-a u promet | Naziv | Međunarodno nezaštićeno ime | Jačina | Farmaceutski oblik | Vrsta životinja | Put primjene |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Francuska | Virbac |
| 1ere Avenue 2065M LID |
| 06516 Carros Cedex |
| France |

Država članica EU-a/EGP-a

Nositelj odobrenja za stavljanje VMP-a u promet

Naziv

Međunarodno nezaštićeno ime

Jačina

Farmaceutski oblik

Vrsta životinja

Put primjene

Francuska

Virbac

1ere Avenue 2065M LID

06516 Carros Cedex

France

Adjusol TMP Sulfa Liquide

trimetoprim

sulfadijazin

16,65  mg/ml

83,35  mg/ml

Oralna otopina

Goveda (telad), ovce (janjad), svinje, kunići, perad (pilići, purice, patke)

Oralna primjena

Grčka

| Virbac |
| --- |
| 1ere Avenue 2065M LID |
| 06516 Carros Cedex |
| France |

Virbac

1ere Avenue 2065M LID

06516 Carros Cedex

France

ADJUSOL TMP SULFA πόσιμο διάλυμα (1,665 +8,335 )g/100ml

trimetoprim

sulfadijazin

16,65  mg/ml

83,35  mg/ml

Oralna otopina

Brojleri

Oralna primjena

Luksemburg

| Virbac |
| --- |
| 1ere Avenue 2065M LID |
| 06516 Carros Cedex |
| France |

Virbac

1ere Avenue 2065M LID

06516 Carros Cedex

France

ADJUSOL TMP SULFA LIQUIDE

trimetoprim

sulfadijazin

16,65  mg/ml

83,35  mg/ml

Oralna otopina

Goveda (telad), ovce (janjad), svinje, kunići, perad (pilići, purice, patke)

Oralna primjena

Portugal

| Virbac |
| --- |
| 1ere Avenue 2065M LID |
| 06516 Carros Cedex |
| France |

Virbac

1ere Avenue 2065M LID

06516 Carros Cedex

France

ADJUSOL TMP SULFA LIQUIDO, solução oral para administração na água de bebida para frangos de carne

trimetoprim

sulfadijazin

16,65  mg/ml

83,35  mg/ml

Oralna otopina

Brojleri

Oralna primjena

---