# Eiropas Savienības C 465/2018

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 465 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 61. gadagājums2018. gada 27. decembris |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 465

Izdevums latviešu valodā

Informācija un paziņojumi

61. gadagājums2018. gada 27. decembris

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| Saturs | Lappuse |
| --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2018/C 465/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. novembra līdz 2018. gada 30. novembrim(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu) | 1 |

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2018/C 465/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. novembra līdz 2018. gada 30. novembrim(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

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| LV | |
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LV

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IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

| 27.12.2018 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 465/1 |
| --- | --- | --- | --- |

27.12.2018

LV

Eiropas Savienības Oficiālais Vēstnesis

C 465/1

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. novembra līdz 2018. gada 30. novembrim

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

(2018/C 465/01)

| — | Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas |
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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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.11.2018. | Emgality | galkanezumabs | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/18/1330 | Šķīdums injekcijai | N02CX08 | 16.11.2018. |
| 20.11.2018. | Apealea | paclitaxel | Oasmia Pharmaceutical AB
  Vallongatan 1, 75228 Uppsala, Sverige | EU/1/18/1292 | Pulveris infūziju šķīduma pagatavošanai | L01CD01 | 22.11.2018. |
| 20.11.2018. | Buvidal | buprenorphine | Camurus AB
  Ideon Science Park, 223 70 Lund, Sverige | EU/1/18/1336 | Ilgstošās darbības šķīdums injekcijai | N07BC01 | 22.11.2018. |
| 20.11.2018. | Fulphila | pegfilgrastīms | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1329 | Šķīdums injekcijai | L03AA13 | 22.11.2018. |
| 20.11.2018. | Pelmeg | pegfilgrastīms | Cinfa Biotech S.L.
  Travesía de Roncesvalles 1, 31699 Olloki (Navarra), España | EU/1/18/1328 | Šķīdums injekcijai | L03AA13 | 22.11.2018. |
| 20.11.2018. | Vabomere | meropenem/vaborbactam | Rempex London Limited
  115L Milton Park, Abingdon, Oxfordshire, OX14 4SA United Kingdom | EU/1/18/1334 | Pulveris infūziju šķīduma koncentrāta pagatavošanai | J01DH52 | 22.11.2018. |
| 20.11.2018. | Venclyxto | venetoklakss | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/16/1138 | Apvalkotās tabletes | L01XX52 | 22.11.2018. |
| 22.11.2018. | Alunbrig | brigatinib | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/18/1264 | Apvalkotās tabletes | L01XE43 | 26.11.2018. |
| 22.11.2018. | Delstrigo | doravirīns/lamivudīns/tenofovīra disoproksils | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1333 | Apvalkotās tabletes | J05AG24 | 26.11.2018. |
| 22.11.2018. | Jivi | damoctocog alfa pegol | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/18/1324 | Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | B02BD02 | 26.11.2018. |
| 22.11.2018. | Luxturna | voretigēna neparvoveks | Spark Therapeutics Ireland Ltd
  Studio G3,The Tower, Trinity Technology & Enterprise Campus, Pearse Street, Dublin 2, Ireland | EU/1/18/1331 | Koncentrāts un šķīdinātājs injekciju šķīduma pagatavošanai | Pending | 5.12.2018. |
| 22.11.2018. | Pifeltro | doravirīns | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1332 | Apvalkotās tabletes | J05AG06 | 27.11.2018. |
| 22.11.2018. | Poteligeo | Mogamulizumabs | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/18/1335 | Koncentrāts infūziju šķīduma pagatavošanai | L01XC25 | 26.11.2018. |
| 22.11.2018. | TAKHZYRO | lanadelumabs | Shire Pharmaceuticals Ireland Limited
  Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, IRELAND | EU/1/18/1340 | Šķīdums injekcijai | B06AC05 | 26.11.2018. |
| 22.11.2018. | Ziextenzo | pegfilgrastim | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1327 | Šķīdums injekcijai | L03AA13 | 26.11.2018. |

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

14.11.2018.

Emgality

galkanezumabs

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/18/1330

Šķīdums injekcijai

N02CX08

16.11.2018.

20.11.2018.

Apealea

paclitaxel

Oasmia Pharmaceutical AB

Vallongatan 1, 75228 Uppsala, Sverige

EU/1/18/1292

Pulveris infūziju šķīduma pagatavošanai

L01CD01

22.11.2018.

20.11.2018.

Buvidal

buprenorphine

Camurus AB

Ideon Science Park, 223 70 Lund, Sverige

EU/1/18/1336

Ilgstošās darbības šķīdums injekcijai

N07BC01

22.11.2018.

20.11.2018.

Fulphila

pegfilgrastīms

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1329

Šķīdums injekcijai

L03AA13

22.11.2018.

20.11.2018.

Pelmeg

pegfilgrastīms

Cinfa Biotech S.L.

Travesía de Roncesvalles 1, 31699 Olloki (Navarra), España

EU/1/18/1328

Šķīdums injekcijai

L03AA13

22.11.2018.

20.11.2018.

Vabomere

meropenem/vaborbactam

Rempex London Limited

115L Milton Park, Abingdon, Oxfordshire, OX14 4SA United Kingdom

EU/1/18/1334

Pulveris infūziju šķīduma koncentrāta pagatavošanai

J01DH52

22.11.2018.

20.11.2018.

Venclyxto

venetoklakss

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/16/1138

Apvalkotās tabletes

L01XX52

22.11.2018.

22.11.2018.

Alunbrig

brigatinib

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/18/1264

Apvalkotās tabletes

L01XE43

26.11.2018.

22.11.2018.

Delstrigo

doravirīns/lamivudīns/tenofovīra disoproksils

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1333

Apvalkotās tabletes

J05AG24

26.11.2018.

22.11.2018.

Jivi

damoctocog alfa pegol

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/18/1324

Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

B02BD02

26.11.2018.

22.11.2018.

Luxturna

voretigēna neparvoveks

Spark Therapeutics Ireland Ltd

Studio G3,The Tower, Trinity Technology & Enterprise Campus, Pearse Street, Dublin 2, Ireland

EU/1/18/1331

Koncentrāts un šķīdinātājs injekciju šķīduma pagatavošanai

Pending

5.12.2018.

22.11.2018.

Pifeltro

doravirīns

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1332

Apvalkotās tabletes

J05AG06

27.11.2018.

22.11.2018.

Poteligeo

Mogamulizumabs

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/18/1335

Koncentrāts infūziju šķīduma pagatavošanai

L01XC25

26.11.2018.

22.11.2018.

TAKHZYRO

lanadelumabs

Shire Pharmaceuticals Ireland Limited

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

EU/1/18/1340

Šķīdums injekcijai

B06AC05

26.11.2018.

22.11.2018.

Ziextenzo

pegfilgrastim

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1327

Šķīdums injekcijai

L03AA13

26.11.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 8.11.2018. | Benepali | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/15/1074 | 13.11.2018. |
| 8.11.2018. | Benepali | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/15/1074 | 15.11.2018. |
| 8.11.2018. | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/17/1210 | 12.11.2018. |
| 8.11.2018. | Flixabi | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/16/1106 | 15.11.2018. |
| 8.11.2018. | Irbesartan HCT Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/06/377 | 12.11.2018. |
| 8.11.2018. | Neupro | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/331 | 12.11.2018. |
| 8.11.2018. | Ontruzant | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/17/1241 | 16.11.2018. |
| 8.11.2018. | Ruconest | Pharming Group N.V.
  Darwinweg 24, 2333 CR Leiden, Nederland | EU/1/10/641 | 12.11.2018. |
| 8.11.2018. | Spinraza | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/17/1188 | 12.11.2018. |
| 8.11.2018. | Tracleer | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/02/220 | 12.11.2018. |
| 8.11.2018. | Xeljanz | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/17/1178 | 12.11.2018. |
| 12.11.2018. | Bemfola | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/13/909 | 14.11.2018. |
| 12.11.2018. | CABOMETYX | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/16/1136 | 14.11.2018. |
| 12.11.2018. | Clopidogrel ratiopharm | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/975 | 14.11.2018. |
| 12.11.2018. | Desloratadine ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/11/746 | 14.11.2018. |
| 12.11.2018. | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1051 | 14.11.2018. |
| 12.11.2018. | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1052 | 14.11.2018. |
| 12.11.2018. | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/983 | 14.11.2018. |
| 12.11.2018. | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/795 | 14.11.2018. |
| 12.11.2018. | Jinarc | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Nederland | EU/1/15/1000 | 14.11.2018. |
| 12.11.2018. | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/899 | 14.11.2018. |
| 12.11.2018. | Olanzapine Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/08/475 | 7.12.2018. |
| 12.11.2018. | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/900 | 14.11.2018. |
| 14.11.2018. | Benlysta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/11/700 | 16.11.2018. |
| 14.11.2018. | Daptomycin Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | EU/1/17/1175 | 16.11.2018. |
| 14.11.2018. | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/922 | 16.11.2018. |
| 14.11.2018. | Izba | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/905 | 16.11.2018. |
| 14.11.2018. | Latuda | Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.
  Viale Amelia 70, 00181 Roma, Italia | EU/1/14/913 | 16.11.2018. |
| 14.11.2018. | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/899 | 16.11.2018. |
| 14.11.2018. | Tecfidera | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/13/837 | 16.11.2018. |
| 20.11.2018. | Brineura | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/17/1192 | 22.11.2018. |
| 20.11.2018. | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/13/891 | 22.11.2018. |
| 20.11.2018. | Emtricitabine/Tenofovir disoproxil Krka | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/16/1151 | 22.11.2018. |
| 20.11.2018. | Fluenz Tetra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/887 | 22.11.2018. |
| 20.11.2018. | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/922 | 22.11.2018. |
| 20.11.2018. | Levetiracetam Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/13/889 | 22.11.2018. |
| 20.11.2018. | Neuraceq | Life Radiopharma Berlin GmbH
  Max-Planck-Straße 4, 12489 Berlin, Deutschland | EU/1/13/906 | 22.11.2018. |
| 20.11.2018. | NovoSeven | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/96/006 | 22.11.2018. |
| 20.11.2018. | Orfadin | Swedish Orphan Biovitrum International AB
  112 76 Stockholm, Sverige | EU/1/04/303 | 23.11.2018. |
| 20.11.2018. | Ozurdex | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/10/638 | 22.11.2018. |
| 20.11.2018. | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/06/380 | 22.11.2018. |
| 20.11.2018. | Rapiscan | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/10/643 | 22.11.2018. |
| 20.11.2018. | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/967 | 22.11.2018. |
| 20.11.2018. | Selincro | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/12/815 | 22.11.2018. |
| 20.11.2018. | Symtuza | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1225 | 22.11.2018. |
| 20.11.2018. | Zoledronic acid Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/834 | 22.11.2018. |
| 22.11.2018. | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | EU/1/07/430 | 26.11.2018. |
| 22.11.2018. | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 26.11.2018. |
| 22.11.2018. | Docetaxel Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/07/384 | 26.11.2018. |
| 22.11.2018. | Efient | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/08/503 | 26.11.2018. |
| 22.11.2018. | Erivedge | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/848 | 26.11.2018. |
| 22.11.2018. | GILENYA | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/677 | 28.11.2018. |
| 22.11.2018. | Inlyta | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/12/777 | 26.11.2018. |
| 22.11.2018. | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, 1030 Wien, Österreich | EU/1/08/501 | 26.11.2018. |
| 22.11.2018. | Kalydeco | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/12/782 | 26.11.2018. |
| 22.11.2018. | Kentera | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/03/270 | 26.11.2018. |
| 22.11.2018. | Kyprolis | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1060 | 26.11.2018. |
| 22.11.2018. | Levetiracetam Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/13/889 | 26.11.2018. |
| 22.11.2018. | Mirvaso | Galderma International
  Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | EU/1/13/904 | 26.11.2018. |
| 22.11.2018. | Nyxoid | Mundipharma Corporation (Ireland) Limited
  Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland | EU/1/17/1238 | 26.11.2018. |
| 22.11.2018. | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/462 | 26.11.2018. |
| 22.11.2018. | Soliris | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/07/393 | 27.11.2018. |
| 22.11.2018. | Synflorix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/09/508 | 26.11.2018. |
| 22.11.2018. | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 26.11.2018. |
| 22.11.2018. | Wakix | Bioprojet Pharma
  9 rue Rameau, 75002 Paris, France | EU/1/15/1068 | 26.11.2018. |
| 22.11.2018. | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | EU/1/12/785 | 26.11.2018. |
| 26.11.2018. | alli | GlaxoSmithKline Dungarvan Limited
  Knockbrack, Dungarvan, Co. Waterford, Ireland | EU/1/07/401 | 29.11.2018. |
| 26.11.2018. | Anoro Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/898 | 28.11.2018. |
| 26.11.2018. | Darunavir Krka d.d. | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/17/1248 | 28.11.2018. |
| 26.11.2018. | Docetaxel Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/07/384 | 28.11.2018. |
| 26.11.2018. | Kalydeco | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/12/782 | 28.11.2018. |
| 26.11.2018. | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/10/654 | 28.11.2018. |
| 26.11.2018. | Orkambi | Vertex Pharmaceuticals (Ireland) Limited
  28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | EU/1/15/1059 | 28.11.2018. |
| 26.11.2018. | PHEBURANE | Eurocept International BV
  Trapgans 5, 1244 RL Ankeveen, Nederland | EU/1/13/822 | 28.11.2018. |
| 26.11.2018. | Zeffix | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/99/114 | 28.11.2018. |
| 28.11.2018. | AMGEVITA | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1164 | 30.11.2018. |
| 28.11.2018. | Pregabalin Zentiva k.s | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1166 | 30.11.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

8.11.2018.

Benepali

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/15/1074

13.11.2018.

8.11.2018.

Benepali

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/15/1074

15.11.2018.

8.11.2018.

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/17/1210

12.11.2018.

8.11.2018.

Flixabi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/16/1106

15.11.2018.

8.11.2018.

Irbesartan HCT Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/06/377

12.11.2018.

8.11.2018.

Neupro

UCB Pharma S.A.

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

EU/1/05/331

12.11.2018.

8.11.2018.

Ontruzant

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1241

16.11.2018.

8.11.2018.

Ruconest

Pharming Group N.V.

Darwinweg 24, 2333 CR Leiden, Nederland

EU/1/10/641

12.11.2018.

8.11.2018.

Spinraza

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/17/1188

12.11.2018.

8.11.2018.

Tracleer

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/02/220

12.11.2018.

8.11.2018.

Xeljanz

Pfizer Europe MA EEIG

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

EU/1/17/1178

12.11.2018.

12.11.2018.

Bemfola

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/13/909

14.11.2018.

12.11.2018.

CABOMETYX

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/16/1136

14.11.2018.

12.11.2018.

Clopidogrel ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/975

14.11.2018.

12.11.2018.

Desloratadine ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/11/746

14.11.2018.

12.11.2018.

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

14.11.2018.

12.11.2018.

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1052

14.11.2018.

12.11.2018.

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

14.11.2018.

12.11.2018.

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

14.11.2018.

12.11.2018.

Jinarc

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

EU/1/15/1000

14.11.2018.

12.11.2018.

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

14.11.2018.

12.11.2018.

Olanzapine Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/08/475

7.12.2018.

12.11.2018.

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

14.11.2018.

14.11.2018.

Benlysta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/11/700

16.11.2018.

14.11.2018.

Daptomycin Hospira

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

EU/1/17/1175

16.11.2018.

14.11.2018.

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

16.11.2018.

14.11.2018.

Izba

Novartis Europharm Limited

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

EU/1/13/905

16.11.2018.

14.11.2018.

Latuda

Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.

Viale Amelia 70, 00181 Roma, Italia

EU/1/14/913

16.11.2018.

14.11.2018.

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

16.11.2018.

14.11.2018.

Tecfidera

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/13/837

16.11.2018.

20.11.2018.

Brineura

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/17/1192

22.11.2018.

20.11.2018.

Brintellix

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/13/891

22.11.2018.

20.11.2018.

Emtricitabine/Tenofovir disoproxil Krka

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/16/1151

22.11.2018.

20.11.2018.

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/887

22.11.2018.

20.11.2018.

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

22.11.2018.

20.11.2018.

Levetiracetam Hospira

Pfizer Europe MA EEIG

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

EU/1/13/889

22.11.2018.

20.11.2018.

Neuraceq

Life Radiopharma Berlin GmbH

Max-Planck-Straße 4, 12489 Berlin, Deutschland

EU/1/13/906

22.11.2018.

20.11.2018.

NovoSeven

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/96/006

22.11.2018.

20.11.2018.

Orfadin

Swedish Orphan Biovitrum International AB

112 76 Stockholm, Sverige

EU/1/04/303

23.11.2018.

20.11.2018.

Ozurdex

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/10/638

22.11.2018.

20.11.2018.

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/06/380

22.11.2018.

20.11.2018.

Rapiscan

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/10/643

22.11.2018.

20.11.2018.

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/967

22.11.2018.

20.11.2018.

Selincro

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/12/815

22.11.2018.

20.11.2018.

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

22.11.2018.

20.11.2018.

Zoledronic acid Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

EU/1/13/834

22.11.2018.

22.11.2018.

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430

26.11.2018.

22.11.2018.

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

26.11.2018.

22.11.2018.

Docetaxel Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/07/384

26.11.2018.

22.11.2018.

Efient

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/08/503

26.11.2018.

22.11.2018.

Erivedge

Roche Registration GmbH

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

EU/1/13/848

26.11.2018.

22.11.2018.

GILENYA

Novartis Europharm Limited

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

EU/1/11/677

28.11.2018.

22.11.2018.

Inlyta

Pfizer Europe MA EEIG

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

EU/1/12/777

26.11.2018.

22.11.2018.

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

EU/1/08/501

26.11.2018.

22.11.2018.

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/12/782

26.11.2018.

22.11.2018.

Kentera

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/03/270

26.11.2018.

22.11.2018.

Kyprolis

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

26.11.2018.

22.11.2018.

Levetiracetam Hospira

Pfizer Europe MA EEIG

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

EU/1/13/889

26.11.2018.

22.11.2018.

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

26.11.2018.

22.11.2018.

Nyxoid

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

EU/1/17/1238

26.11.2018.

22.11.2018.

Ranexa

Menarini International Operations Luxembourg S.A.

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

EU/1/08/462

26.11.2018.

22.11.2018.

Soliris

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/07/393

27.11.2018.

22.11.2018.

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/09/508

26.11.2018.

22.11.2018.

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

26.11.2018.

22.11.2018.

Wakix

Bioprojet Pharma

9 rue Rameau, 75002 Paris, France

EU/1/15/1068

26.11.2018.

22.11.2018.

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/12/785

26.11.2018.

26.11.2018.

alli

GlaxoSmithKline Dungarvan Limited

Knockbrack, Dungarvan, Co. Waterford, Ireland

EU/1/07/401

29.11.2018.

26.11.2018.

Anoro Ellipta

Glaxo Group Ltd

980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/14/898

28.11.2018.

26.11.2018.

Darunavir Krka d.d.

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/17/1248

28.11.2018.

26.11.2018.

Docetaxel Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/07/384

28.11.2018.

26.11.2018.

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/12/782

28.11.2018.

26.11.2018.

Leflunomide ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/10/654

28.11.2018.

26.11.2018.

Orkambi

Vertex Pharmaceuticals (Ireland) Limited

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

EU/1/15/1059

28.11.2018.

26.11.2018.

PHEBURANE

Eurocept International BV

Trapgans 5, 1244 RL Ankeveen, Nederland

EU/1/13/822

28.11.2018.

26.11.2018.

Zeffix

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/99/114

28.11.2018.

28.11.2018.

AMGEVITA

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1164

30.11.2018.

28.11.2018.

Pregabalin Zentiva k.s

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1166

30.11.2018.

| — | Tirdzniecības atļaujas izņemšana no aprites (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants) |
| --- | --- |

—

Tirdzniecības atļaujas izņemšana no aprites (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants)

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 12.11.2018. | Eperzan | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/13/908 | 14.11.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

12.11.2018.

Eperzan

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/13/908

14.11.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 19.11.2018. | Osurnia | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/14/170 | 21.11.2018. |
| 19.11.2018. | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/07/078 | 21.11.2018. |
| 26.11.2018. | Econor | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | EU/2/98/010 | 28.11.2018. |
| 26.11.2018. | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/11/134 | 29.11.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

19.11.2018.

Osurnia

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/14/170

21.11.2018.

19.11.2018.

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

21.11.2018.

26.11.2018.

Econor

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

EU/2/98/010

28.11.2018.

26.11.2018.

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/11/134

29.11.2018.

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

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

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