# Eiropas Savienības C 334/2019

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 334 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 62. gadagājums2019. gada 4. oktobris |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 334

Izdevums latviešu valodā

Informācija un paziņojumi

62. gadagājums2019. gada 4. oktobris

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| Saturs | Lappuse |
| --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2019/C 334/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2019. gada 1. jūlija līdz 2019. gada 31. augustam  (Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu) | 1 |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| 2019/C 334/02 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2019. gada 1. jūlija līdz 2019. gada 31. augustam(Lēmumi pieņemti saskaņā ar Direktīvas 2001/83/EK 34. pantu vai Direktīvas 2001/82/EK 38. pantu) | 17 |

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2019/C 334/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2019. gada 1. jūlija līdz 2019. gada 31. augustam  (Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)

(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)

1

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

2019/C 334/02

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2019. gada 1. jūlija līdz 2019. gada 31. augustam(Lēmumi pieņemti saskaņā ar Direktīvas 2001/83/EK 34. pantu vai Direktīvas 2001/82/EK 38. pantu)

(Lēmumi pieņemti saskaņā ar Direktīvas 2001/83/EK 34. pantu vai Direktīvas 2001/82/EK 38. pantu)

17

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LV

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IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

| 4.10.2019 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 334/1 |
| --- | --- | --- | --- |

4.10.2019

LV

Eiropas Savienības Oficiālais Vēstnesis

C 334/1

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2019. gada 1. jūlija līdz 2019. gada 31. augustam

(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004
   (1) 13. vai 38. pantu)

(2019/C 334/01)

| — | Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas |
| --- | --- |

—

Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.7.2019. | Dovato | dolutegravirum/lamivudinum | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/19/1370 | Apvalkotās tabletes | J05AR25 | 3.7.2019. |
| 1.7.2019. | Xromi | hidroksikarbamīds | Nova Laboratories Ireland Limited
  3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland | EU/1/19/1366 | Šķīdums iekšķīgai lietošanai | L01XX05 | 3.7.2019. |
| 2.7.2019. | Ultomiris | Ravulizumab | Alexion Europe SAS
  103-105 Rue Anatole France, 92300 Levallois-Perret, France | EU/1/19/1371 | Koncentrāts infūziju šķīduma pagatavošanai | L04AA | 5.7.2019. |
| 25.7.2019. | Cufence | trientīna dihidrohlorīda | Univar BV
  Schouwburgplein 30-34, 3012 CL Rotterdam, Nederland | EU/1/19/1365 | Cietās kapsulas | A16AX12 | 29.7.2019. |
| 25.7.2019. | LysaKare | arginīns/lizīns | Advanced Accelerator Applications
  20 rue Diesel, 01630 Saint-Genis-Pouilly, France | EU/1/19/1381 | Šķīdums infūzijām | V03AF11 | 29.7.2019. |
| 25.7.2019. | Posaconazole Accord | posakonazola | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, Barcelona, 08039 Barcelona, España | EU/1/19/1379 | Zarnās šķīstošās tabletes | J02AC04 | 30.7.2019. |
| 25.7.2019. | Posaconazole AHCL | posaconazolum | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/19/1380 | Suspensija iekšķīgai lietošanai | J02AC04 | 29.7.2019. |
| 2.8.2019. | Azacitidīna Celgene | azacitidīns | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/19/1382 | Pulveris injekciju suspensijas pagatavošanai | L01BC07 | 6.8.2019. |
| 23.8.2019. | Giapreza | angiotensīna II acetāts | La Jolla Pharmaceutical II B.V.
  Herengracht 500, 1017 CB Amsterdam, Nederland | EU/1/19/1384 | Koncentrāts infūziju šķīduma pagatavošanai | C01CX09 | 27.8.2019. |
| 26.8.2019. | Lacosamide UCB | Lacosamidum | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/19/1383 | Apvalkotās tabletes Sīrups Šķīdums infūzijām | N03AX18 | 28.8.2019. |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

1.7.2019.

Dovato

dolutegravirum/lamivudinum

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/19/1370

Apvalkotās tabletes

J05AR25

3.7.2019.

1.7.2019.

Xromi

hidroksikarbamīds

Nova Laboratories Ireland Limited

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

EU/1/19/1366

Šķīdums iekšķīgai lietošanai

L01XX05

3.7.2019.

2.7.2019.

Ultomiris

Ravulizumab

Alexion Europe SAS

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

EU/1/19/1371

Koncentrāts infūziju šķīduma pagatavošanai

L04AA

5.7.2019.

25.7.2019.

Cufence

trientīna dihidrohlorīda

Univar BV

Schouwburgplein 30-34, 3012 CL Rotterdam, Nederland

EU/1/19/1365

Cietās kapsulas

A16AX12

29.7.2019.

25.7.2019.

LysaKare

arginīns/lizīns

Advanced Accelerator Applications

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

EU/1/19/1381

Šķīdums infūzijām

V03AF11

29.7.2019.

25.7.2019.

Posaconazole Accord

posakonazola

Accord Healthcare S.L.U.

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

EU/1/19/1379

Zarnās šķīstošās tabletes

J02AC04

30.7.2019.

25.7.2019.

Posaconazole AHCL

posaconazolum

Accord Healthcare S.L.U.

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

EU/1/19/1380

Suspensija iekšķīgai lietošanai

J02AC04

29.7.2019.

2.8.2019.

Azacitidīna Celgene

azacitidīns

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/19/1382

Pulveris injekciju suspensijas pagatavošanai

L01BC07

6.8.2019.

23.8.2019.

Giapreza

angiotensīna II acetāts

La Jolla Pharmaceutical II B.V.

Herengracht 500, 1017 CB Amsterdam, Nederland

EU/1/19/1384

Koncentrāts infūziju šķīduma pagatavošanai

C01CX09

27.8.2019.

26.8.2019.

Lacosamide UCB

Lacosamidum

UCB Pharma S.A.

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

EU/1/19/1383

Apvalkotās tabletes Sīrups Šķīdums infūzijām

N03AX18

28.8.2019.

| — | Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): noraidītas |
| --- | --- |

—

Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): noraidītas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 11.7.2019. | Cabazitaxel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | — | 15.7.2019. |
| 8.8.2019. | Doxolipad | TLC Biopharmaceuticals B.V.
  J.H. Oortweg 19, 2333CH Leiden, Netherlands | — | 12.8.2019. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

11.7.2019.

Cabazitaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

—

15.7.2019.

8.8.2019.

Doxolipad

TLC Biopharmaceuticals B.V.

J.H. Oortweg 19, 2333CH Leiden, Netherlands

—

12.8.2019.

| — | Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas |
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Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 1.7.2019. | Benlysta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/11/700 | 3.7.2019. |
| 1.7.2019. | Cetrotide | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/99/100 | 3.7.2019. |
| 1.7.2019. | Comtan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/081 | 3.7.2019. |
| 1.7.2019. | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland | EU/1/11/691 | 3.7.2019. |
| 1.7.2019. | Eviplera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/11/737 | 3.7.2019. |
| 1.7.2019. | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/983 | 3.7.2019. |
| 1.7.2019. | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/16/1160 | 3.7.2019. |
| 1.7.2019. | Instanyl | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/09/531 | 3.7.2019. |
| 1.7.2019. | Mimpara | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/04/292 | 3.7.2019. |
| 1.7.2019. | Ravicti | Immedica Pharma AB
  SE-113 29 Stockholm, Sverige | EU/1/15/1062 | 3.7.2019. |
| 1.7.2019. | Symtuza | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1225 | 3.7.2019. |
| 1.7.2019. | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 3.7.2019. |
| 4.7.2019. | Dukoral | Valneva Sweden AB
  105 21 Stockholm, Sverige | EU/1/03/263 | 8.7.2019. |
| 4.7.2019. | IKERVIS | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | EU/1/15/990 | 8.7.2019. |
| 4.7.2019. | Kaletra | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/01/172 | 8.7.2019. |
| 4.7.2019. | Nerlynx | Pierre Fabre Médicament
  45, place Abel Gance, 92100 Boulogne-Billancourt, France | EU/1/18/1311 | 9.7.2019. |
| 4.7.2019. | Orphacol | Laboratoires CTRS
  63 rue de l’Est, 92100 Boulogne-Billancourt, France | EU/1/13/870 | 8.7.2019. |
| 4.7.2019. | Prolia | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/10/618 | 8.7.2019. |
| 4.7.2019. | Verkazia | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | EU/1/17/1219 | 8.7.2019. |
| 4.7.2019. | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | EU/1/12/785 | 8.7.2019. |
| 8.7.2019. | Emtricitabine/Tenofovir disoproxil Krka d.d. | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1182 | 10.7.2019. |
| 8.7.2019. | Hefiya | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1287 | 10.7.2019. |
| 8.7.2019. | Pazenir | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/18/1317 | 10.7.2019. |
| 8.7.2019. | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 10.7.2019. |
| 8.7.2019. | Tremfya | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1234 | 10.7.2019. |
| 8.7.2019. | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 10.7.2019. |
| 8.7.2019. | Xultophy | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/14/947 | 10.7.2019. |
| 9.7.2019. | Elocta | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/15/1046 | 11.7.2019. |
| 11.7.2019. | Ammonaps | Immedica Pharma AB
  SE-113 29 Stockholm, Sverige | EU/1/99/120 | 15.7.2019. |
| 11.7.2019. | Defitelio | Gentium S.r.I.
  Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia | EU/1/13/878 | 15.7.2019. |
| 11.7.2019. | Gliolan | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/07/413 | 15.7.2019. |
| 11.7.2019. | Halimatoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1288 | 15.7.2019. |
| 11.7.2019. | Tasigna | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/422 | 15.7.2019. |
| 18.7.2019. | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 29.7.2019. |
| 18.7.2019. | Myocet | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/00/141 | 22.7.2019. |
| 18.7.2019. | Norvir | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/96/016 | 22.7.2019. |
| 18.7.2019. | Xadago | Zambon S.p.A.
  Via Lillo del Duca 10, 20091 Bresso (MI), Italia | EU/1/14/984 | 22.7.2019. |
| 18.7.2019. | Xyrem | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/312 | 22.7.2019. |
| 19.7.2019. | Besponsa | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/17/1200 | 23.7.2019. |
| 19.7.2019. | Colobreathe | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/747 | 23.7.2019. |
| 19.7.2019. | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 23.7.2019. |
| 19.7.2019. | Exjade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/356 | 23.7.2019. |
| 19.7.2019. | HyQvia | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/13/840 | 23.7.2019. |
| 19.7.2019. | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/922 | 23.7.2019. |
| 19.7.2019. | Lartruvo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1143 | 23.7.2019. |
| 19.7.2019. | Truvada | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/04/305 | 23.7.2019. |
| 19.7.2019. | Truxima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/16/1167 | 23.7.2019. |
| 25.7.2019. | Abasaglar | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/944 | 29.7.2019. |
| 25.7.2019. | Abraxane | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/07/428 | 29.7.2019. |
| 25.7.2019. | Anoro Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/898 | 29.7.2019. |
| 25.7.2019. | Blitzima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1205 | 29.7.2019. |
| 25.7.2019. | Corbilta | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/13/859 | 29.7.2019. |
| 25.7.2019. | Deltyba | Otsuka Novel Products GmbH
  Erika-Mann-Straße 21, 80636 München, Deutschland | EU/1/13/875 | 29.7.2019. |
| 25.7.2019. | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 29.7.2019. |
| 25.7.2019. | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/795 | 29.7.2019. |
| 25.7.2019. | Gardasil 9 | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | 29.7.2019. |
| 25.7.2019. | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 29.7.2019. |
| 25.7.2019. | Hepsera | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/03/251 | 29.7.2019. |
| 25.7.2019. | Herceptin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/145 | 29.7.2019. |
| 25.7.2019. | KANJINTI | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/18/1281 | 29.7.2019. |
| 25.7.2019. | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/15/993 | 29.7.2019. |
| 25.7.2019. | Maviret | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/17/1213 | 29.7.2019. |
| 25.7.2019. | NexoBrid | MediWound Germany GmbH
  Eisenstraße 5, 65428 Ruesselsheim, Deutschland | EU/1/12/803 | 29.7.2019. |
| 25.7.2019. | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 29.7.2019. |
| 25.7.2019. | Ontruzant | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/17/1241 | 29.7.2019. |
| 25.7.2019. | Ritemvia | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1207 | 29.7.2019. |
| 25.7.2019. | Rolufta Ellipta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1174 | 29.7.2019. |
| 25.7.2019. | Roteas | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/16/1152 | 29.7.2019. |
| 25.7.2019. | Telmisartan Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/719 | 29.7.2019. |
| 25.7.2019. | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/11/697 | 29.7.2019. |
| 25.7.2019. | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 29.7.2019. |
| 25.7.2019. | Uptravi | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/15/1083 | 29.7.2019. |
| 25.7.2019. | Visudyne | CHEPLAPHARM Arzneimittel GmbH
  Ziegelhof 24, 17489 Greifswald, Deutschland | EU/1/00/140 | 29.7.2019. |
| 25.7.2019. | Vizamyl | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/14/941 | 29.7.2019. |
| 25.7.2019. | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/900 | 29.7.2019. |
| 25.7.2019. | Zalmoxis | MolMed S.p.A.
  Via Olgettina 58, 20132 Milano, Italia | EU/1/16/1121 | 29.7.2019. |
| 25.7.2019. | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | EU/1/12/785 | 29.7.2019. |
| 25.7.2019. | Zometa | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/176 | 29.7.2019. |
| 31.7.2019. | Aclasta | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/308 | 2.8.2019. |
| 31.7.2019. | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/447 | 5.8.2019. |
| 31.7.2019. | Adjupanrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/09/578 | 2.8.2019. |
| 31.7.2019. | Duloxetine Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/972 | 2.8.2019. |
| 31.7.2019. | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/16/1160 | 2.8.2019. |
| 31.7.2019. | Flebogamma DIF | Instituto Grifols, S.A.
  Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa | EU/1/07/404 | 2.8.2019. |
| 31.7.2019. | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/795 | 2.8.2019. |
| 31.7.2019. | Inovelon | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/06/378 | 2.8.2019. |
| 31.7.2019. | Invirase | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/96/026 | 2.8.2019. |
| 31.7.2019. | Ketoconazole HRA | Laboratoire HRA Pharma
  200 avenue de Paris, 92320 Chatillon, France | EU/1/14/965 | 2.8.2019. |
| 31.7.2019. | Nucala | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/15/1043 | 2.8.2019. |
| 31.7.2019. | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 2.8.2019. |
| 31.7.2019. | Stalevo | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/03/260 | 2.8.2019. |
| 31.7.2019. | Tadalafil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/14/961 | 2.8.2019. |
| 31.7.2019. | Thalidomide Celgene | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/08/443 | 2.8.2019. |
| 31.7.2019. | Trazimera | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/18/1295 | 2.8.2019. |
| 31.7.2019. | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 2.8.2019. |
| 31.7.2019. | Vimpat | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/08/470 | 2.8.2019. |
| 31.7.2019. | Xydalba | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/14/986 | 2.8.2019. |
| 1.8.2019. | Cyramza | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/957 | 5.8.2019. |
| 1.8.2019. | Dupixent | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/17/1229 | 5.8.2019. |
| 1.8.2019. | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1051 | 5.8.2019. |
| 1.8.2019. | Faslodex | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/03/269 | 5.8.2019. |
| 1.8.2019. | Harvoni | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/14/958 | 6.8.2019. |
| 1.8.2019. | Herzuma | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1257 | 6.8.2019. |
| 1.8.2019. | Hirobriz Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/594 | 6.8.2019. |
| 1.8.2019. | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/899 | 6.8.2019. |
| 2.8.2019. | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/17/1222 | 6.8.2019. |
| 2.8.2019. | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 6.8.2019. |
| 2.8.2019. | JETREA | Oxurion NV
  Gaston Geenslaan 1, 3001 Leuven, België | EU/1/13/819 | 6.8.2019. |
| 2.8.2019. | Praxbind | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1056 | 7.8.2019. |
| 8.8.2019. | InductOs | Medtronic BioPharma B.V.
  Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland | EU/1/02/226 | 12.8.2019. |
| 8.8.2019. | Levodopa/Carbidopa/Entacapone Orion | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/11/706 | 12.8.2019. |
| 8.8.2019. | Stivarga | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/858 | 12.8.2019. |
| 8.8.2019. | Teysuno | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | EU/1/11/669 | 12.8.2019. |
| 9.8.2019. | Jivi | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/18/1324 | 13.8.2019. |
| 9.8.2019. | Travatan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/199 | 13.8.2019. |
| 9.8.2019. | Truberzi | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/16/1126 | 13.8.2019. |
| 9.8.2019. | Victoza | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/09/529 | 13.8.2019. |
| 14.8.2019. | Oslif Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/586 | 19.8.2019. |
| 23.8.2019. | Aimovig | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1293 | 27.8.2019. |
| 23.8.2019. | Brimica Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/963 | 27.8.2019. |
| 23.8.2019. | Cinacalcet Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1054 | 27.8.2019. |
| 23.8.2019. | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/13/890 | 27.8.2019. |
| 23.8.2019. | Duaklir Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/14/964 | 27.8.2019. |
| 23.8.2019. | Elmiron | bene-Arzneimittel GmbH
  Herterichstraße 1-3, 81479 München, Deutschland | EU/1/17/1189 | 27.8.2019. |
| 23.8.2019. | Empliciti | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/16/1088 | 27.8.2019. |
| 23.8.2019. | Firdapse | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland | EU/1/09/601 | 27.8.2019. |
| 23.8.2019. | Flucelvax Tetra | Seqirus Netherlands B.V.
  Paasheuvelweg 28, 1105BJ Amsterdam, Netherlands | EU/1/18/1326 | 27.8.2019. |
| 23.8.2019. | Fluenz Tetra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/887 | 27.8.2019. |
| 23.8.2019. | Nordimet | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | EU/1/16/1124 | 27.8.2019. |
| 23.8.2019. | Otezla | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/14/981 | 27.8.2019. |
| 23.8.2019. | Ovitrelle | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/00/165 | 27.8.2019. |
| 23.8.2019. | Renagel | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/99/123 | 27.8.2019. |
| 23.8.2019. | Sevelamer carbonate Winthrop | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/14/952 | 27.8.2019. |
| 23.8.2019. | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/894 | 27.8.2019. |
| 23.8.2019. | Spinraza | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/17/1188 | 27.8.2019. |
| 23.8.2019. | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/956 | 27.8.2019. |
| 23.8.2019. | Zerbaxa | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1032 | 27.8.2019. |
| 26.8.2019. | Emadine | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/095 | 28.8.2019. |
| 26.8.2019. | Imraldi | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/17/1216 | 28.8.2019. |
| 26.8.2019. | Jylamvo | Therakind (Europe) Limited
  3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland | EU/1/17/1172 | 28.8.2019. |
| 26.8.2019. | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 28.8.2019. |
| 26.8.2019. | Levitra | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/03/248 | 28.8.2019. |
| 26.8.2019. | Mycophenolate mofetil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/439 | 28.8.2019. |
| 26.8.2019. | Nevanac | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/433 | 28.8.2019. |
| 26.8.2019. | Onbrez Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/593 | 28.8.2019. |
| 26.8.2019. | Prasugrel Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1273 | 28.8.2019. |
| 26.8.2019. | PREVYMIS | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/17/1245 | 28.8.2019. |
| 26.8.2019. | Renvela | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/09/521 | 28.8.2019. |
| 26.8.2019. | Soliris | Alexion Europe SAS
  103-105 rue Anatole France, 92300 Levallois-Perret, France | EU/1/07/393 | 28.8.2019. |
| 26.8.2019. | TAGRISSO | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1086 | 28.8.2019. |
| 26.8.2019. | Tasmar | Meda AB
  Pipers väg 2A, 170 09 Solna, Sverige | EU/1/97/044 | 28.8.2019. |
| 26.8.2019. | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 28.8.2019. |
| 26.8.2019. | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 28.8.2019. |
| 26.8.2019. | Vivanza | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/03/249 | 28.8.2019. |
| 31.8.2019. | Kisqali | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/17/1221 | 2.8.2019. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

1.7.2019.

Benlysta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/11/700

3.7.2019.

1.7.2019.

Cetrotide

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/99/100

3.7.2019.

1.7.2019.

Comtan

Novartis Europharm Limited

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

EU/1/98/081

3.7.2019.

1.7.2019.

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

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

EU/1/11/691

3.7.2019.

1.7.2019.

Eviplera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/11/737

3.7.2019.

1.7.2019.

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

3.7.2019.

1.7.2019.

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/16/1160

3.7.2019.

1.7.2019.

Instanyl

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/09/531

3.7.2019.

1.7.2019.

Mimpara

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/04/292

3.7.2019.

1.7.2019.

Ravicti

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

EU/1/15/1062

3.7.2019.

1.7.2019.

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

3.7.2019.

1.7.2019.

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

3.7.2019.

4.7.2019.

Dukoral

Valneva Sweden AB

105 21 Stockholm, Sverige

EU/1/03/263

8.7.2019.

4.7.2019.

IKERVIS

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/15/990

8.7.2019.

4.7.2019.

Kaletra

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/01/172

8.7.2019.

4.7.2019.

Nerlynx

Pierre Fabre Médicament

45, place Abel Gance, 92100 Boulogne-Billancourt, France

EU/1/18/1311

9.7.2019.

4.7.2019.

Orphacol

Laboratoires CTRS

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

EU/1/13/870

8.7.2019.

4.7.2019.

Prolia

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/10/618

8.7.2019.

4.7.2019.

Verkazia

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/17/1219

8.7.2019.

4.7.2019.

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

8.7.2019.

8.7.2019.

Emtricitabine/Tenofovir disoproxil Krka d.d.

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1182

10.7.2019.

8.7.2019.

Hefiya

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

10.7.2019.

8.7.2019.

Pazenir

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/18/1317

10.7.2019.

8.7.2019.

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

10.7.2019.

8.7.2019.

Tremfya

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1234

10.7.2019.

8.7.2019.

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

10.7.2019.

8.7.2019.

Xultophy

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/14/947

10.7.2019.

9.7.2019.

Elocta

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/15/1046

11.7.2019.

11.7.2019.

Ammonaps

Immedica Pharma AB

SE-113 29 Stockholm, Sverige

EU/1/99/120

15.7.2019.

11.7.2019.

Defitelio

Gentium S.r.I.

Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia

EU/1/13/878

15.7.2019.

11.7.2019.

Gliolan

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/07/413

15.7.2019.

11.7.2019.

Halimatoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1288

15.7.2019.

11.7.2019.

Tasigna

Novartis Europharm Limited

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

EU/1/07/422

15.7.2019.

18.7.2019.

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

29.7.2019.

18.7.2019.

Myocet

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/00/141

22.7.2019.

18.7.2019.

Norvir

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/96/016

22.7.2019.

18.7.2019.

Xadago

Zambon S.p.A.

Via Lillo del Duca 10, 20091 Bresso (MI), Italia

EU/1/14/984

22.7.2019.

18.7.2019.

Xyrem

UCB Pharma S.A.

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

EU/1/05/312

22.7.2019.

19.7.2019.

Besponsa

Pfizer Europe MA EEIG

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

EU/1/17/1200

23.7.2019.

19.7.2019.

Colobreathe

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/747

23.7.2019.

19.7.2019.

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

23.7.2019.

19.7.2019.

Exjade

Novartis Europharm Limited

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

EU/1/06/356

23.7.2019.

19.7.2019.

HyQvia

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/13/840

23.7.2019.

19.7.2019.

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

23.7.2019.

19.7.2019.

Lartruvo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1143

23.7.2019.

19.7.2019.

Truvada

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/04/305

23.7.2019.

19.7.2019.

Truxima

Celltrion Healthcare Hungary Kft.

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

EU/1/16/1167

23.7.2019.

25.7.2019.

Abasaglar

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/944

29.7.2019.

25.7.2019.

Abraxane

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/428

29.7.2019.

25.7.2019.

Anoro Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/898

29.7.2019.

25.7.2019.

Blitzima

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1205

29.7.2019.

25.7.2019.

Corbilta

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/13/859

29.7.2019.

25.7.2019.

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

29.7.2019.

25.7.2019.

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

29.7.2019.

25.7.2019.

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

29.7.2019.

25.7.2019.

Gardasil 9

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

29.7.2019.

25.7.2019.

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

29.7.2019.

25.7.2019.

Hepsera

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/03/251

29.7.2019.

25.7.2019.

Herceptin

Roche Registration GmbH

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

EU/1/00/145

29.7.2019.

25.7.2019.

KANJINTI

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/18/1281

29.7.2019.

25.7.2019.

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

29.7.2019.

25.7.2019.

Maviret

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/17/1213

29.7.2019.

25.7.2019.

NexoBrid

MediWound Germany GmbH

Eisenstraße 5, 65428 Ruesselsheim, Deutschland

EU/1/12/803

29.7.2019.

25.7.2019.

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

29.7.2019.

25.7.2019.

Ontruzant

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1241

29.7.2019.

25.7.2019.

Ritemvia

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1207

29.7.2019.

25.7.2019.

Rolufta Ellipta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1174

29.7.2019.

25.7.2019.

Roteas

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/16/1152

29.7.2019.

25.7.2019.

Telmisartan Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/719

29.7.2019.

25.7.2019.

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/697

29.7.2019.

25.7.2019.

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

29.7.2019.

25.7.2019.

Uptravi

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/15/1083

29.7.2019.

25.7.2019.

Visudyne

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Deutschland

EU/1/00/140

29.7.2019.

25.7.2019.

Vizamyl

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/14/941

29.7.2019.

25.7.2019.

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

29.7.2019.

25.7.2019.

Zalmoxis

MolMed S.p.A.

Via Olgettina 58, 20132 Milano, Italia

EU/1/16/1121

29.7.2019.

25.7.2019.

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

29.7.2019.

25.7.2019.

Zometa

Novartis Europharm Limited

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

EU/1/01/176

29.7.2019.

31.7.2019.

Aclasta

Novartis Europharm Limited

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

EU/1/05/308

2.8.2019.

31.7.2019.

Adenuric

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/08/447

5.8.2019.

31.7.2019.

Adjupanrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/09/578

2.8.2019.

31.7.2019.

Duloxetine Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/972

2.8.2019.

31.7.2019.

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/16/1160

2.8.2019.

31.7.2019.

Flebogamma DIF

Instituto Grifols, S.A.

Can Guasch 2, Parets del Vallès, 08150 Barcelona, Espaňa

EU/1/07/404

2.8.2019.

31.7.2019.

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

2.8.2019.

31.7.2019.

Inovelon

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/06/378

2.8.2019.

31.7.2019.

Invirase

Roche Registration GmbH

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

EU/1/96/026

2.8.2019.

31.7.2019.

Ketoconazole HRA

Laboratoire HRA Pharma

200 avenue de Paris, 92320 Chatillon, France

EU/1/14/965

2.8.2019.

31.7.2019.

Nucala

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/15/1043

2.8.2019.

31.7.2019.

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

2.8.2019.

31.7.2019.

Stalevo

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/03/260

2.8.2019.

31.7.2019.

Tadalafil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/14/961

2.8.2019.

31.7.2019.

Thalidomide Celgene

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/443

2.8.2019.

31.7.2019.

Trazimera

Pfizer Europe MA EEIG

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

EU/1/18/1295

2.8.2019.

31.7.2019.

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

2.8.2019.

31.7.2019.

Vimpat

UCB Pharma S.A.

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

EU/1/08/470

2.8.2019.

31.7.2019.

Xydalba

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/14/986

2.8.2019.

1.8.2019.

Cyramza

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

5.8.2019.

1.8.2019.

Dupixent

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/17/1229

5.8.2019.

1.8.2019.

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

5.8.2019.

1.8.2019.

Faslodex

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/03/269

5.8.2019.

1.8.2019.

Harvoni

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/14/958

6.8.2019.

1.8.2019.

Herzuma

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1257

6.8.2019.

1.8.2019.

Hirobriz Breezhaler

Novartis Europharm Limited

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

EU/1/09/594

6.8.2019.

1.8.2019.

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

6.8.2019.

2.8.2019.

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/17/1222

6.8.2019.

2.8.2019.

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

6.8.2019.

2.8.2019.

JETREA

Oxurion NV

Gaston Geenslaan 1, 3001 Leuven, België

EU/1/13/819

6.8.2019.

2.8.2019.

Praxbind

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1056

7.8.2019.

8.8.2019.

InductOs

Medtronic BioPharma B.V.

Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland

EU/1/02/226

12.8.2019.

8.8.2019.

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/706

12.8.2019.

8.8.2019.

Stivarga

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/858

12.8.2019.

8.8.2019.

Teysuno

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/11/669

12.8.2019.

9.8.2019.

Jivi

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/18/1324

13.8.2019.

9.8.2019.

Travatan

Novartis Europharm Limited

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

EU/1/01/199

13.8.2019.

9.8.2019.

Truberzi

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/16/1126

13.8.2019.

9.8.2019.

Victoza

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/09/529

13.8.2019.

14.8.2019.

Oslif Breezhaler

Novartis Europharm Limited

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

EU/1/09/586

19.8.2019.

23.8.2019.

Aimovig

Novartis Europharm Limited

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

EU/1/18/1293

27.8.2019.

23.8.2019.

Brimica Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/963

27.8.2019.

23.8.2019.

Cinacalcet Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1054

27.8.2019.

23.8.2019.

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/13/890

27.8.2019.

23.8.2019.

Duaklir Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/14/964

27.8.2019.

23.8.2019.

Elmiron

bene-Arzneimittel GmbH

Herterichstraße 1-3, 81479 München, Deutschland

EU/1/17/1189

27.8.2019.

23.8.2019.

Empliciti

Bristol-Myers Squibb Pharma EEIG

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

EU/1/16/1088

27.8.2019.

23.8.2019.

Firdapse

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland

EU/1/09/601

27.8.2019.

23.8.2019.

Flucelvax Tetra

Seqirus Netherlands B.V.

Paasheuvelweg 28, 1105BJ Amsterdam, Netherlands

EU/1/18/1326

27.8.2019.

23.8.2019.

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

27.8.2019.

23.8.2019.

Nordimet

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/16/1124

27.8.2019.

23.8.2019.

Otezla

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/14/981

27.8.2019.

23.8.2019.

Ovitrelle

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/00/165

27.8.2019.

23.8.2019.

Renagel

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/99/123

27.8.2019.

23.8.2019.

Sevelamer carbonate Winthrop

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/14/952

27.8.2019.

23.8.2019.

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/894

27.8.2019.

23.8.2019.

Spinraza

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/17/1188

27.8.2019.

23.8.2019.

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

27.8.2019.

23.8.2019.

Zerbaxa

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1032

27.8.2019.

26.8.2019.

Emadine

Novartis Europharm Limited

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

EU/1/98/095

28.8.2019.

26.8.2019.

Imraldi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1216

28.8.2019.

26.8.2019.

Jylamvo

Therakind (Europe) Limited

3 Inn’s Quay, Dublin 7, D07 PW4F, Ireland

EU/1/17/1172

28.8.2019.

26.8.2019.

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

28.8.2019.

26.8.2019.

Levitra

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/248

28.8.2019.

26.8.2019.

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

28.8.2019.

26.8.2019.

Nevanac

Novartis Europharm Limited

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

EU/1/07/433

28.8.2019.

26.8.2019.

Onbrez Breezhaler

Novartis Europharm Limited

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

EU/1/09/593

28.8.2019.

26.8.2019.

Prasugrel Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1273

28.8.2019.

26.8.2019.

PREVYMIS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

28.8.2019.

26.8.2019.

Renvela

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/09/521

28.8.2019.

26.8.2019.

Soliris

Alexion Europe SAS

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

EU/1/07/393

28.8.2019.

26.8.2019.

TAGRISSO

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1086

28.8.2019.

26.8.2019.

Tasmar

Meda AB

Pipers väg 2A, 170 09 Solna, Sverige

EU/1/97/044

28.8.2019.

26.8.2019.

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

28.8.2019.

26.8.2019.

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

28.8.2019.

26.8.2019.

Vivanza

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/249

28.8.2019.

31.8.2019.

Kisqali

Novartis Europharm Limited

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

EU/1/17/1221

2.8.2019.

| — | Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas |
| --- | --- |

—

Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 19.7.2019. | EVICTO | selamektīns | VIRBAC
  1ère avenue – 2065m – LID, 06516 Carros, France | EU/2/19/242 | Spot-on šķīdums | QP54AA05 | 23.7.2019. |
| 29.7.2019. | NASYM | Dzīvs novājināts liellopu respiratori sincitiālais vīruss (BRSV), celms Lym-56 | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/19/241 | Liofilizāts un šķīdinātājs suspensijas injekcijām vai deguna aerosola pagatavošanai | QI02AD04 | 31.7.2019. |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

19.7.2019.

EVICTO

selamektīns

VIRBAC

1ère avenue – 2065m – LID, 06516 Carros, France

EU/2/19/242

Spot-on šķīdums

QP54AA05

23.7.2019.

29.7.2019.

NASYM

Dzīvs novājināts liellopu respiratori sincitiālais vīruss (BRSV), celms Lym-56

Laboratorios Hipra, S.A.

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

EU/2/19/241

Liofilizāts un šķīdinātājs suspensijas injekcijām vai deguna aerosola pagatavošanai

QI02AD04

31.7.2019.

| — | Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas |
| --- | --- |

—

Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 1.7.2019. | Osurnia | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/14/170 | 3.7.2019. |
| 4.7.2019. | Bravecto Plus | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/18/224 | 9.7.2019. |
| 29.7.2019. | Advocate | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/03/039 | 31.7.2019. |
| 9.8.2019. | Vectormune ND | CEVA-Phylaxia Co. Ltd
  Szállás u. 5, 1107 Budapest, Magyarország | EU/2/15/188 | 13.8.2019. |
| 19.8.2019. | NexGard | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/159 | 21.8.2019. |
| 19.8.2019. | NEXGARD SPECTRA | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/14/177 | 21.8.2019. |
| 29.8.2019. | Bovilis Blue-8 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/17/218 | 2.9.2019. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

1.7.2019.

Osurnia

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/14/170

3.7.2019.

4.7.2019.

Bravecto Plus

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/18/224

9.7.2019.

29.7.2019.

Advocate

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/03/039

31.7.2019.

9.8.2019.

Vectormune ND

CEVA-Phylaxia Co. Ltd

Szállás u. 5, 1107 Budapest, Magyarország

EU/2/15/188

13.8.2019.

19.8.2019.

NexGard

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/159

21.8.2019.

19.8.2019.

NEXGARD SPECTRA

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/14/177

21.8.2019.

29.8.2019.

Bovilis Blue-8

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/17/218

2.9.2019.

Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

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

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

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(1)  OV L 136, 30.4.2004., 1. lpp.

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EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

| 4.10.2019 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 334/17 |
| --- | --- | --- | --- |

4.10.2019

LV

Eiropas Savienības Oficiālais Vēstnesis

C 334/17

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2019. gada 1. jūlija līdz 2019. gada 31. augustam

(Lēmumi pieņemti saskaņā ar Direktīvas 2001/83/EK
   (1) 34. pantu vai Direktīvas 2001/82/EK (2) 38. pantu)

(2019/C 334/02)

| — | Atteikums grozīt valsts tirdzniecības atļauju |
| --- | --- |

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Atteikums grozīt valsts tirdzniecības atļauju

| Lēmuma datums | Zāļu nosaukums(-i) | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs(-i) | Attiecīgā dalībvalsts | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- |
| 4.7.2019. | Basiron AC and associated names | benzoyl peroxide | Nav piemērojams | Nav piemērojams | 5.7.2019. |

Lēmuma datums

Zāļu nosaukums(-i)

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs(-i)

Attiecīgā dalībvalsts

Paziņojuma datums

4.7.2019.

Basiron AC and associated names

benzoyl peroxide

Nav piemērojams

Nav piemērojams

5.7.2019.

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(1)  OV L 311, 28.11.2001., 1. lpp.

(2)  OV L 311, 28.11.2001., 67. lpp.

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