# Službeni list C 176/29.

| | ISSN 1977-1088 |
| --- | --- |
| Službeni list
  Europske unije | C 176 |
| | |
| Hrvatsko izdanje | Informacije i objave | Godište 65.29. travnja 2022. |

ISSN 1977-1088

Službeni list

Europske unije

C 176

Hrvatsko izdanje

Informacije i objave

Godište 65.29. travnja 2022.

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| Sadržaj | Stranica |
| --- | --- |
| | IV.   Obavijesti |
| | OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE |
| | Europska komisija |
| 2022/C 176/01 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2022. do 31. ožujka 2022.(Objavljeno u skladu s člankom 13. ili člankom 38. Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća) | 1 |
| 2022/C 176/02 | Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2022. do 31. ožujka 2022.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC ili člankom 38. Direktive 2001/82/EC) | 8 |

Sadržaj

Stranica

IV.   Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

2022/C 176/01

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2022. do 31. ožujka 2022.(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

2022/C 176/02

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2022. do 31. ožujka 2022.(Odluke donesene u skladu s člankom 34. Direktive 2001/83/EC ili člankom 38. Direktive 2001/82/EC)

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

8

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

HR

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IV. Obavijesti

OBAVIJESTI INSTITUCIJA, TIJELA, UREDA I AGENCIJA EUROPSKE UNIJE

Europska komisija

| 29.4.2022 | HR | Službeni list Europske unije | C 176/1 |
| --- | --- | --- | --- |

29.4.2022

HR

Službeni list Europske unije

C 176/1

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2022. do 31. ožujka 2022.

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

(2022/C 176/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 24.3.2022. | Dasatinib Accord | dasatinib | Accord Healthcare S.L.U. |
| World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |

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

24.3.2022.

Dasatinib Accord

dasatinib

Accord Healthcare S.L.U.

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

EU/1/21/1540

Filmom obložena tableta

L01EA02

25.3.2022.

24.3.2022.

Dasatinib Accordpharma

dasatinib

| 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/1/21/1541

Filmom obložena tableta

L01EA02

25.3.2022.

24.3.2022.

Sondelbay

teriparatid

| 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/1/22/1628

Otopina za injekciju

H05AA02

25.3.2022.

24.3.2022.

Vildagliptin/metforminklorid Accord

vildagliptin/metforminklorid

| 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/1/21/1611

Filmom obložena tableta

A10BD08

25.3.2022.

28.3.2022.

Stimufend

pegfilgrastim

| 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/1/22/1632

Otopina za injekciju

L03AA13

29.3.2022.

—   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 |
| --- | --- | --- | --- | --- |
| 2.3.2022. | COVID-19 Vaccine Janssen | Janssen-Cilag International NV |
| Turnhoutseweg 30, 2340 Beerse, België |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

2.3.2022.

COVID-19 Vaccine Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/20/1525

3.3.2022.

2.3.2022.

Spikevax

| MODERNA BIOTECH SPAIN, S.L. |
| --- |
| Calle Monte Esquinza 30, 28010 Madrid, España |

MODERNA BIOTECH SPAIN, S.L.

Calle Monte Esquinza 30, 28010 Madrid, España

EU/1/20/1507

3.3.2022.

3.3.2022.

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

4.3.2022.

4.3.2022.

Entecavir 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/1/17/1211

8.3.2022.

4.3.2022.

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

9.3.2022.

4.3.2022.

MAVENCLAD

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

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1212

7.3.2022.

4.3.2022.

Pandemic influenza vaccine H5N1 AstraZeneca

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1089

7.3.2022.

4.3.2022.

Rubraca

| Clovis Oncology Ireland Limited |
| --- |
| Regus Dublin Airport, Skybridge House – Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland |

Clovis Oncology Ireland Limited

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

EU/1/17/1250

15.3.2022.

4.3.2022.

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

7.3.2022.

4.3.2022.

Synjardy

| 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/1/15/1003

8.3.2022.

4.3.2022.

Vimpat

| 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/1/08/470

8.3.2022.

4.3.2022.

Xeljanz

| 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/1/17/1178

8.3.2022.

4.3.2022.

Zebinix

| 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/1/09/514

7.3.2022.

4.3.2022.

Ziagen

| 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/1/99/112

8.3.2022.

7.3.2022.

Ronapreve

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

Roche Registration GmbH

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

EU/1/21/1601

8.3.2022.

11.3.2022.

Fulphila

| Viatris Limited |
| --- |
| Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland |

Viatris Limited

Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland

EU/1/18/1329

14.3.2022.

18.3.2022.

Dectova

| 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/1/18/1349

28.3.2022.

18.3.2022.

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

23.3.2022.

18.3.2022.

Leflunomide 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/1/09/604

24.3.2022.

18.3.2022.

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

21.3.2022.

18.3.2022.

Telzir

| 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/1/04/282

21.3.2022.

22.3.2022.

Capecitabine Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

24.3.2022.

22.3.2022.

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

23.3.2022.

22.3.2022.

Glivec

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

Novartis Europharm Limited

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

EU/1/01/198

23.3.2022.

22.3.2022.

Jinarc

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

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/15/1000

25.3.2022.

22.3.2022.

Maviret

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

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

23.3.2022.

22.3.2022.

Natpar

| Takeda Pharmaceuticals International AG Ireland Branch |
| --- |
| Block 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland |

Takeda Pharmaceuticals International AG Ireland Branch

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

EU/1/15/1078

23.3.2022.

22.3.2022.

Nemdatine

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

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/824

23.3.2022.

22.3.2022.

Repaglinide Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/530

24.3.2022.

22.3.2022.

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

23.3.2022.

22.3.2022.

Trepulmix

| SciPharm Sàrl |
| --- |
| 7, Fausermillen, 6689 Mertert, Luxembourg |

SciPharm Sàrl

7, Fausermillen, 6689 Mertert, Luxembourg

EU/1/19/1419

24.3.2022.

22.3.2022.

Zynteglo

| bluebird bio (Netherlands) B.V. |
| --- |
| Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland |

bluebird bio (Netherlands) B.V.

Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland

EU/1/19/1367

23.3.2022.

24.3.2022.

Aflunov

| Seqirus S.r.l. |
| --- |
| Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italy |

Seqirus S.r.l.

Via del Pozzo 3/A, S. Martino, 53035 Monteriggioni (SI), Italy

EU/1/10/658

25.3.2022.

24.3.2022.

Atectura 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/1/20/1439

25.3.2022.

24.3.2022.

AYVAKYT

| Blueprint Medicines (Netherlands) B.V. |
| --- |
| Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland |

Blueprint Medicines (Netherlands) B.V.

Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland

EU/1/20/1473

25.3.2022.

24.3.2022.

Capecitabine medac

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

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/12/802

25.3.2022.

24.3.2022.

Gliolan

| photonamic GmbH & Co. KG |
| --- |
| Eggerstedter Weg 12, 25421 Pinneberg, Deutschland |

photonamic GmbH & Co. KG

Eggerstedter Weg 12, 25421 Pinneberg, Deutschland

EU/1/07/413

4.4.2022.

24.3.2022.

Lynparza

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/959

25.3.2022.

24.3.2022.

Olanzapine Teva

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

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/427

4.4.2022.

24.3.2022.

Palynziq

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

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/19/1362

5.4.2022.

24.3.2022.

Recarbrio

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/19/1420

25.3.2022.

24.3.2022.

Rukobia

| 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/1/20/1518

25.3.2022.

24.3.2022.

TAGRISSO

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

25.3.2022.

24.3.2022.

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

25.3.2022.

24.3.2022.

Veltassa

| Vifor Fresenius Medical Care Renal Pharma France |
| --- |
| 100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France |

Vifor Fresenius Medical Care Renal Pharma France

100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France

EU/1/17/1179

29.3.2022.

28.3.2022.

Beovu

| 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/1/19/1417

29.3.2022.

28.3.2022.

Brineura

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

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/17/1192

6.4.2022.

28.3.2022.

Daurismo

| 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/1/20/1451

29.3.2022.

28.3.2022.

Delstrigo

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

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1333

30.3.2022.

28.3.2022.

Nexavar

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

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/06/342

4.4.2022.

28.3.2022.

OBIZUR

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

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/15/1035

29.3.2022.

28.3.2022.

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

30.3.2022.

28.3.2022.

OXERVATE

| Dompé farmaceutici S.p.A. |
| --- |
| Via Santa Lucia 6, 20122 Milano, Italia |

Dompé farmaceutici S.p.A.

Via Santa Lucia 6, 20122 Milano, Italia

EU/1/17/1197

30.3.2022.

28.3.2022.

PHEBURANE

| Eurocept International BV |
| --- |
| Trapgans 5, 1244 RL Ankeveen, Nederland |

Eurocept International BV

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/822

30.3.2022.

28.3.2022.

Vidaza

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

Bristol Myers Squibb Pharma EEIG

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

EU/1/08/488

29.3.2022.

31.3.2022.

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

31.3.2022.

31.3.2022.

Vaxzevria

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

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/21/1529

31.3.2022.

—   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 |
| --- | --- | --- | --- | --- |
| 22.3.2022. | Zynquista | Guidehouse Germany GmbH |
| Albrechtstrasse 10c, 10117 Berlin, Deutschland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

22.3.2022.

Zynquista

Guidehouse Germany GmbH

Albrechtstrasse 10c, 10117 Berlin, Deutschland

EU/1/19/1363

24.3.2022.

24.3.2022.

Zynteglo

| bluebird bio (Netherlands) B.V. |
| --- |
| Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland |

bluebird bio (Netherlands) B.V.

Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland

EU/1/19/1367

29.3.2022.

—   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 |
| --- | --- | --- | --- | --- |
| 4.3.2022. | Nobilis Influenza H5N2 | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

Datum odluke

Naziv lijeka

Nositelj odobrenja za stavljanje u promet

Broj upisa u registar Zajednice

Datum obavijesti

4.3.2022.

Nobilis Influenza H5N2

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/06/061

7.3.2022.

4.3.2022.

Zolvix

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/09/101

8.3.2022.

10.3.2022.

EQUIOXX

| Audevard |
| --- |
| 37-39 Rue De Neuilly, 92110 Clichy, France |

Audevard

37-39 Rue De Neuilly, 92110 Clichy, France

EU/2/08/083

11.3.2022.

10.3.2022.

Kriptazen

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

Virbac

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

EU/2/18/234

14.3.2022.

10.3.2022.

Vectormune ND

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

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/15/188

12.3.2022.

16.3.2022.

Credelio

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

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/17/206

17.3.2022.

16.3.2022.

Nobivac Myxo-RHD

| 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/2/11/132

17.3.2022.

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.

---

| 29.4.2022 | HR | Službeni list Europske unije | C 176/8 |
| --- | --- | --- | --- |

29.4.2022

HR

Službeni list Europske unije

C 176/8

---

Sažetak odluka Europske unije o odobrenjima za stavljanje u promet lijekova od 1. ožujka 2022. do 31. ožujka 2022.

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

(2022/C 176/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 24.3.2022. | etifoxine | etifoxine | Vidi Prilog I. | Vidi Prilog I. | 25.3.2022. |

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

24.3.2022.

etifoxine

etifoxine

Vidi Prilog I.

Vidi Prilog I.

25.3.2022.

—   Odbijanje 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 |
| --- | --- | --- | --- | --- | --- |
| 28.3.2022. | Lidocain/Prilocain IDETEC and associated names | lidocaine/prilocaine | Vidi Prilog II. | Vidi Prilog II. | 29.3.2022. |

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

28.3.2022.

Lidocain/Prilocain IDETEC and associated names

lidocaine/prilocaine

Vidi Prilog II.

Vidi Prilog II.

29.3.2022.

---

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

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

---

PRILOG I.

Popis nacionalno odobrenih lijekova

| Država članica u EGP-u | Nositelj odobrenja za stavljanje lijeka u promet | Naziv lijeka | INN/djelatna tvar + jačina | Farmaceutski oblik | Način primjene |
| --- | --- | --- | --- | --- | --- |
| Bugarska | Biocodex | Стрезам | Etifoksinklorid kapsula 50 mg | Kapsula, tvrda | Primjena kroz usta |
| Francuska | Biocodex | Stresam | Etifoksinklorid kapsula 50 mg | Kapsula, tvrda | Primjena kroz usta |
| Malta | Biocodex | Stresam | Etifoksinklorid kapsula 50 mg | Kapsula, tvrda | Primjena kroz usta |

Država članica u EGP-u

Nositelj odobrenja za stavljanje lijeka u promet

Naziv lijeka

INN/djelatna tvar + jačina

Farmaceutski oblik

Način primjene

Bugarska

Biocodex

Стрезам

Etifoksinklorid kapsula 50 mg

Kapsula, tvrda

Primjena kroz usta

Francuska

Biocodex

Stresam

Etifoksinklorid kapsula 50 mg

Kapsula, tvrda

Primjena kroz usta

Malta

Biocodex

Stresam

Etifoksinklorid kapsula 50 mg

Kapsula, tvrda

Primjena kroz usta

---

PRILOG II.

Popis lijekova i prezentacije

| Država članica
  EU/EGP | Podnositelj zahtjeva | Naziv lijeka | INN + Snaga | Farmaceutski oblik | Put administracije |
| --- | --- | --- | --- | --- | --- |
| Danska | INTERNATIONAL DRUG DEVELOPMENT |
| 104 boulevard Auguste Blanqui |
| 75013 Paris |
| France |

Država članica

EU/EGP

Podnositelj zahtjeva

Naziv lijeka

INN + Snaga

Farmaceutski oblik

Put administracije

Danska

INTERNATIONAL DRUG DEVELOPMENT

104 boulevard Auguste Blanqui

75013 Paris

France

Lidocain/Prilocain IDETEC

lidokain 25 mg/g + prilokain 25 mg/g

Krema

Topikalno

Nizozemska

| INTERNATIONAL DRUG DEVELOPMENT |
| --- |
| 104 boulevard Auguste Blanqui |
| 75013 Paris |
| France |

INTERNATIONAL DRUG DEVELOPMENT

104 boulevard Auguste Blanqui

75013 Paris

France

Lidocaïne/Prilocaïne 5 % Focus, Crème

lidokain 25 mg/g + prilokain 25 mg/g

Krema

Topikalno

---