# Eiropas Savienības C 188/2018

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 188 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 61. gadagājums2018. gada 1. jūnijs |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 188

Izdevums latviešu valodā

Informācija un paziņojumi

61. gadagājums2018. gada 1. jūnijs

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| Saturs | Lappuse |
| --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2018/C 188/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. aprīļa līdz 2018. gada 30. aprīlim(Publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004) | 1 |

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2018/C 188/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. aprīļa līdz 2018. gada 30. aprīlim(Publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004)

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

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

| 1.6.2018 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 188/1 |
| --- | --- | --- | --- |

1.6.2018

LV

Eiropas Savienības Oficiālais Vēstnesis

C 188/1

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. aprīļa līdz 2018. gada 30. aprīlim

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

(2018/C 188/01)

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

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Tirdzniecības atļaujas izsniegšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.4.2018. | Alpivab | peramivīrs | BioCryst UK Ltd.
  c/o Morgan Lewis & Bockius, Condor House, 5-10 St. Paul’s Churchyard, London EC4M 8AL, United Kingdom | EU/1/18/1269 | Koncentrāts infūziju šķīduma pagatavošanai | J05AH03 | 17.4.2018. |
| 19.4.2018. | Mylotarg | gemtuzumaba ozogamicīns | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/18/1277 | Pulveris infūziju šķīduma koncentrāta pagatavošanai | L01XC05 | 23.4.2018. |
| 23.4.2018. | Riarify | beklometazons/formoterols/glikopironija bromīds | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/18/1275 | Aerosols inhalācijām, zem spiediena, šķīdums | R03AL | 26.4.2018. |
| 26.4.2018. | Trydonis | beklometazons/formoterols/glikopironija bromīds | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/18/1274 | Aerosols inhalācijām, zem spiediena, šķīdums | R03AL | 2.5.2018. |

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

13.4.2018.

Alpivab

peramivīrs

BioCryst UK Ltd.

c/o Morgan Lewis & Bockius, Condor House, 5-10 St. Paul’s Churchyard, London EC4M 8AL, United Kingdom

EU/1/18/1269

Koncentrāts infūziju šķīduma pagatavošanai

J05AH03

17.4.2018.

19.4.2018.

Mylotarg

gemtuzumaba ozogamicīns

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/18/1277

Pulveris infūziju šķīduma koncentrāta pagatavošanai

L01XC05

23.4.2018.

23.4.2018.

Riarify

beklometazons/formoterols/glikopironija bromīds

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1275

Aerosols inhalācijām, zem spiediena, šķīdums

R03AL

26.4.2018.

26.4.2018.

Trydonis

beklometazons/formoterols/glikopironija bromīds

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/18/1274

Aerosols inhalācijām, zem spiediena, šķīdums

R03AL

2.5.2018.

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

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

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 6.4.2018. | EnCyzix | Renable Pharma Limited
  20-22 Bedford Row, London WC1R 4JS, United Kingdom | — | 23.4.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

6.4.2018.

EnCyzix

Renable Pharma Limited

20-22 Bedford Row, London WC1R 4JS, United Kingdom

—

23.4.2018.

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

—

Tirdzniecības atļaujas grozīšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 4.4.2018. | Bondronat | Atnahs Pharma UK Limited
  Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom | EU/1/96/012 | 6.4.2018. |
| 4.4.2018. | Bonviva | Atnahs Pharma UK Limited
  Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom | EU/1/03/265 | 6.4.2018. |
| 4.4.2018. | Esbriet | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/11/667 | 6.4.2018. |
| 4.4.2018. | Kinzalmono | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/98/091 | 6.4.2018. |
| 4.4.2018. | Lacosamide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/17/1230 | 6.4.2018. |
| 4.4.2018. | Lumark | IDB Holland B.V.
  Weverstraat 17, 5111 PV Baarle-Nassau, Nederland | EU/1/15/1013 | 6.4.2018. |
| 4.4.2018. | Marixino | KRKA, d.d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/820 | 6.4.2018. |
| 4.4.2018. | Pandemic influenza vaccine H5N1 AstraZeneca | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1089 | 6.4.2018. |
| 4.4.2018. | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 6.4.2018. |
| 6.4.2018. | Fuzeon | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/03/252 | 10.4.2018. |
| 6.4.2018. | Gazyvaro | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/14/937 | 10.4.2018. |
| 6.4.2018. | Herceptin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/145 | 10.4.2018. |
| 6.4.2018. | Kineret | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/02/203 | 10.4.2018. |
| 6.4.2018. | Revolade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/612 | 10.4.2018. |
| 6.4.2018. | RoActemra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/08/492 | 10.4.2018. |
| 6.4.2018. | Tamiflu | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/02/222 | 10.4.2018. |
| 6.4.2018. | Tarceva | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/05/311 | 10.4.2018. |
| 6.4.2018. | Zelboraf | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/12/751 | 10.4.2018. |
| 12.4.2018. | Actraphane | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/02/229 | 16.4.2018. |
| 12.4.2018. | Actrapid | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/02/230 | 16.4.2018. |
| 12.4.2018. | Azopt | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/00/129 | 16.4.2018. |
| 12.4.2018. | Extavia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/454 | 16.4.2018. |
| 12.4.2018. | Farydak | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/1023 | 16.4.2018. |
| 12.4.2018. | Ferriprox | Apotex Europe B.V.
  Darwinweg 20, 2333 CR Leiden, Nederland | EU/1/99/108 | 16.4.2018. |
| 12.4.2018. | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/16/1160 | 16.4.2018. |
| 12.4.2018. | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/795 | 16.4.2018. |
| 12.4.2018. | Galafold | Amicus Therapeutics UK Ltd
  Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom | EU/1/15/1082 | 16.4.2018. |
| 12.4.2018. | Icandra | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/484 | 16.4.2018. |
| 12.4.2018. | Kinzalkomb | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/02/214 | 16.4.2018. |
| 12.4.2018. | Kisqali | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/17/1221 | 16.4.2018. |
| 12.4.2018. | Lumigan | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/02/205 | 16.4.2018. |
| 12.4.2018. | Mekinist | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/931 | 16.4.2018. |
| 12.4.2018. | Neparvis | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/16/1103 | 16.4.2018. |
| 12.4.2018. | Pemetrexed Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1034 | 16.4.2018. |
| 12.4.2018. | Ravicti | Horizon Pharma Ireland Limited
  Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland | EU/1/15/1062 | 16.4.2018. |
| 12.4.2018. | RoActemra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/08/492 | 16.4.2018. |
| 12.4.2018. | Sebivo | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/388 | 16.4.2018. |
| 12.4.2018. | Sialanar | Proveca Limited
  Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom | EU/1/16/1135 | 17.4.2018. |
| 12.4.2018. | Signifor | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/753 | 16.4.2018. |
| 12.4.2018. | Simulect | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/084 | 16.4.2018. |
| 12.4.2018. | Sylvant | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/928 | 16.4.2018. |
| 12.4.2018. | Tadalafil Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/14/961 | 16.4.2018. |
| 12.4.2018. | Vidaza | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/488 | 16.4.2018. |
| 12.4.2018. | Zomarist | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/483 | 16.4.2018. |
| 13.4.2018. | Bretaris Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/781 | 17.4.2018. |
| 13.4.2018. | Eklira Genuair | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/12/778 | 17.4.2018. |
| 13.4.2018. | Memantine ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/13/836 | 17.4.2018. |
| 13.4.2018. | Pritor | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/98/089 | 17.4.2018. |
| 13.4.2018. | PritorPlus | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/02/215 | 17.4.2018. |
| 13.4.2018. | Sialanar | Proveca Limited
  Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom | EU/1/16/1135 | 17.4.2018. |
| 13.4.2018. | Travatan | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/199 | 17.4.2018. |
| 19.4.2018. | Aclasta | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/308 | 23.4.2018. |
| 19.4.2018. | Azarga | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/482 | 23.4.2018. |
| 19.4.2018. | Blincyto | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | 23.4.2018. |
| 19.4.2018. | Comtan | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/98/081 | 23.4.2018. |
| 19.4.2018. | Deltyba | Otsuka Novel Products GmbH
  Erika-Mann-Straße 21, 80636 München, Deutschland | EU/1/13/875 | 23.4.2018. |
| 19.4.2018. | Descovy | Gilead Sciences International Limited
  Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom | EU/1/16/1099 | 23.4.2018. |
| 19.4.2018. | Exjade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/356 | 23.4.2018. |
| 19.4.2018. | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 23.4.2018. |
| 19.4.2018. | Imatinib Medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/13/876 | 23.4.2018. |
| 19.4.2018. | Kyprolis | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1060 | 23.4.2018. |
| 19.4.2018. | Movymia | STADA Arzneimittel AG
  Stadastraße 2-18, 61118 Bad Vilbel, Deutschland | EU/1/16/1161 | 23.4.2018. |
| 19.4.2018. | Natpar | Shire Pharmaceuticals Ireland Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/15/1078 | 23.4.2018. |
| 19.4.2018. | Opatanol | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/02/217 | 23.4.2018. |
| 19.4.2018. | Peyona | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/09/528 | 23.4.2018. |
| 19.4.2018. | Repatha | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1016 | 23.4.2018. |
| 19.4.2018. | Simbrinza | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/933 | 23.4.2018. |
| 19.4.2018. | Stribild | Gilead Sciences International Limited
  Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom | EU/1/13/830 | 23.4.2018. |
| 19.4.2018. | Suliqua | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/16/1157 | 23.4.2018. |
| 19.4.2018. | Sutent | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/347 | 23.4.2018. |
| 19.4.2018. | Volibris | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/08/451 | 23.4.2018. |
| 19.4.2018. | Xadago | Zambon S.p.A.
  Via Lillo del Duca 10, 20 091 Bresso (MI), Italia | EU/1/14/984 | 23.4.2018. |
| 19.4.2018. | Yargesa | JensonR+ Limited
  Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom | EU/1/17/1176 | 23.4.2018. |
| 23.4.2018. | Aerinaze | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/399 | 25.4.2018. |
| 23.4.2018. | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 25.4.2018. |
| 23.4.2018. | Daxas | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/10/636 | 25.4.2018. |
| 23.4.2018. | Desloratadine Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/11/745 | 25.4.2018. |
| 23.4.2018. | Duloxetine Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1028 | 25.4.2018. |
| 23.4.2018. | Emadine | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/095 | 25.4.2018. |
| 23.4.2018. | Entresto | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/1058 | 25.4.2018. |
| 23.4.2018. | Eucreas | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/425 | 25.4.2018. |
| 23.4.2018. | Exelon | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/98/066 | 25.4.2018. |
| 23.4.2018. | Fycompa | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/12/776 | 25.4.2018. |
| 23.4.2018. | GILENYA | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/677 | 25.4.2018. |
| 23.4.2018. | Humira | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/03/256 | 25.4.2018. |
| 23.4.2018. | Hycamtin | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/96/027 | 25.4.2018. |
| 23.4.2018. | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 25.4.2018. |
| 23.4.2018. | Imvanex | Bavarian Nordic A/S
  Hejreskovvej 10a, 3490 Kvistgaard, Danmark | EU/1/13/855 | 25.4.2018. |
| 23.4.2018. | Lojuxta | Aegerion Pharmaceuticals Limited
  Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom | EU/1/13/851 | 25.4.2018. |
| 23.4.2018. | NeuroBloc | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/00/166 | 25.4.2018. |
| 23.4.2018. | Nevanac | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/433 | 25.4.2018. |
| 23.4.2018. | Onbrez Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/593 | 25.4.2018. |
| 23.4.2018. | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 25.4.2018. |
| 23.4.2018. | Pregabalin Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1021 | 25.4.2018. |
| 23.4.2018. | Spedra | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/13/841 | 25.4.2018. |
| 23.4.2018. | TOBI Podhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/652 | 25.4.2018. |
| 23.4.2018. | Viread | Gilead Sciences International Limited
  Cambridge CB21 6GT United Kingdom | EU/1/01/200 | 25.4.2018. |
| 23.4.2018. | Zydelig | Gilead Sciences International Limited
  Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom | EU/1/14/938 | 25.4.2018. |
| 23.4.2018. | Zykadia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | 25.4.2018. |
| 26.4.2018. | Aloxi | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Ireland | EU/1/04/306 | 30.4.2018. |
| 26.4.2018. | Avonex | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/97/033 | 30.4.2018. |
| 26.4.2018. | Cosentyx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/980 | 30.4.2018. |
| 26.4.2018. | Elonva | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/609 | 30.4.2018. |
| 26.4.2018. | Firazyr | Shire Orphan Therapies GmbH
  Friedrichstraße 149, 10117 Berlin, Deutschland | EU/1/08/461 | 30.4.2018. |
| 26.4.2018. | Galvus | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/414 | 30.4.2018. |
| 26.4.2018. | Jalra | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/485 | 30.4.2018. |
| 26.4.2018. | Lucentis | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/374 | 30.4.2018. |
| 26.4.2018. | Maviret | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/17/1213 | 30.4.2018. |
| 26.4.2018. | Tasigna | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/422 | 30.4.2018. |
| 26.4.2018. | Truxima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/16/1167 | 2.5.2018. |
| 26.4.2018. | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/13/857 | 30.4.2018. |
| 26.4.2018. | Xiliarx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/08/486 | 30.4.2018. |
| 26.4.2018. | Xolair | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/05/319 | 30.4.2018. |
| 26.4.2018. | Zometa | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/01/176 | 30.4.2018. |
| 30.4.2018. | Avamys | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/434 | 3.5.2018. |
| 30.4.2018. | Clopidogrel Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/08/465 | 3.5.2018. |
| 30.4.2018. | Entresto | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/1058 | 3.5.2018. |
| 30.4.2018. | Hemlibra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/18/1271 | 3.5.2018. |
| 30.4.2018. | Perjeta | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/813 | 3.5.2018. |
| 30.4.2018. | Pramipexole Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/490 | 3.5.2018. |
| 30.4.2018. | Remsima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/13/853 | 3.5.2018. |
| 30.4.2018. | Rydapt | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/17/1218 | 3.5.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

4.4.2018.

Bondronat

Atnahs Pharma UK Limited

Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom

EU/1/96/012

6.4.2018.

4.4.2018.

Bonviva

Atnahs Pharma UK Limited

Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom

EU/1/03/265

6.4.2018.

4.4.2018.

Esbriet

Roche Registration GmbH

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

EU/1/11/667

6.4.2018.

4.4.2018.

Kinzalmono

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/98/091

6.4.2018.

4.4.2018.

Lacosamide Accord

Accord Healthcare Limited

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

EU/1/17/1230

6.4.2018.

4.4.2018.

Lumark

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

6.4.2018.

4.4.2018.

Marixino

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/820

6.4.2018.

4.4.2018.

Pandemic influenza vaccine H5N1 AstraZeneca

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1089

6.4.2018.

4.4.2018.

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

6.4.2018.

6.4.2018.

Fuzeon

Roche Registration GmbH

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

EU/1/03/252

10.4.2018.

6.4.2018.

Gazyvaro

Roche Registration GmbH

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

EU/1/14/937

10.4.2018.

6.4.2018.

Herceptin

Roche Registration GmbH

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

EU/1/00/145

10.4.2018.

6.4.2018.

Kineret

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/02/203

10.4.2018.

6.4.2018.

Revolade

Novartis Europharm Limited

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

EU/1/10/612

10.4.2018.

6.4.2018.

RoActemra

Roche Registration GmbH

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

EU/1/08/492

10.4.2018.

6.4.2018.

Tamiflu

Roche Registration GmbH

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

EU/1/02/222

10.4.2018.

6.4.2018.

Tarceva

Roche Registration GmbH

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

EU/1/05/311

10.4.2018.

6.4.2018.

Zelboraf

Roche Registration GmbH

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

EU/1/12/751

10.4.2018.

12.4.2018.

Actraphane

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/02/229

16.4.2018.

12.4.2018.

Actrapid

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/02/230

16.4.2018.

12.4.2018.

Azopt

Novartis Europharm Limited

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

EU/1/00/129

16.4.2018.

12.4.2018.

Extavia

Novartis Europharm Limited

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

EU/1/08/454

16.4.2018.

12.4.2018.

Farydak

Novartis Europharm Limited

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

EU/1/15/1023

16.4.2018.

12.4.2018.

Ferriprox

Apotex Europe B.V.

Darwinweg 20, 2333 CR Leiden, Nederland

EU/1/99/108

16.4.2018.

12.4.2018.

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/16/1160

16.4.2018.

12.4.2018.

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/795

16.4.2018.

12.4.2018.

Galafold

Amicus Therapeutics UK Ltd

Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom

EU/1/15/1082

16.4.2018.

12.4.2018.

Icandra

Novartis Europharm Limited

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

EU/1/08/484

16.4.2018.

12.4.2018.

Kinzalkomb

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/214

16.4.2018.

12.4.2018.

Kisqali

Novartis Europharm Limited

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

EU/1/17/1221

16.4.2018.

12.4.2018.

Lumigan

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/02/205

16.4.2018.

12.4.2018.

Mekinist

Novartis Europharm Limited

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

EU/1/14/931

16.4.2018.

12.4.2018.

Neparvis

Novartis Europharm Limited

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

EU/1/16/1103

16.4.2018.

12.4.2018.

Pemetrexed Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1034

16.4.2018.

12.4.2018.

Ravicti

Horizon Pharma Ireland Limited

Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

EU/1/15/1062

16.4.2018.

12.4.2018.

RoActemra

Roche Registration GmbH

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

EU/1/08/492

16.4.2018.

12.4.2018.

Sebivo

Novartis Europharm Limited

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

EU/1/07/388

16.4.2018.

12.4.2018.

Sialanar

Proveca Limited

Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom

EU/1/16/1135

17.4.2018.

12.4.2018.

Signifor

Novartis Europharm Limited

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

EU/1/12/753

16.4.2018.

12.4.2018.

Simulect

Novartis Europharm Limited

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

EU/1/98/084

16.4.2018.

12.4.2018.

Sylvant

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/928

16.4.2018.

12.4.2018.

Tadalafil Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/14/961

16.4.2018.

12.4.2018.

Vidaza

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/08/488

16.4.2018.

12.4.2018.

Zomarist

Novartis Europharm Limited

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

EU/1/08/483

16.4.2018.

13.4.2018.

Bretaris Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/781

17.4.2018.

13.4.2018.

Eklira Genuair

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/12/778

17.4.2018.

13.4.2018.

Memantine ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/13/836

17.4.2018.

13.4.2018.

Pritor

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/98/089

17.4.2018.

13.4.2018.

PritorPlus

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/02/215

17.4.2018.

13.4.2018.

Sialanar

Proveca Limited

Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom

EU/1/16/1135

17.4.2018.

13.4.2018.

Travatan

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/199

17.4.2018.

19.4.2018.

Aclasta

Novartis Europharm Limited

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

EU/1/05/308

23.4.2018.

19.4.2018.

Azarga

Novartis Europharm Limited

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

EU/1/08/482

23.4.2018.

19.4.2018.

Blincyto

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

23.4.2018.

19.4.2018.

Comtan

Novartis Europharm Limited

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

EU/1/98/081

23.4.2018.

19.4.2018.

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, 80636 München, Deutschland

EU/1/13/875

23.4.2018.

19.4.2018.

Descovy

Gilead Sciences International Limited

Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom

EU/1/16/1099

23.4.2018.

19.4.2018.

Exjade

Novartis Europharm Limited

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

EU/1/06/356

23.4.2018.

19.4.2018.

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

23.4.2018.

19.4.2018.

Imatinib Medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/13/876

23.4.2018.

19.4.2018.

Kyprolis

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1060

23.4.2018.

19.4.2018.

Movymia

STADA Arzneimittel AG

Stadastraße 2-18, 61118 Bad Vilbel, Deutschland

EU/1/16/1161

23.4.2018.

19.4.2018.

Natpar

Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/15/1078

23.4.2018.

19.4.2018.

Opatanol

Novartis Europharm Limited

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

EU/1/02/217

23.4.2018.

19.4.2018.

Peyona

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/09/528

23.4.2018.

19.4.2018.

Repatha

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1016

23.4.2018.

19.4.2018.

Simbrinza

Novartis Europharm Limited

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

EU/1/14/933

23.4.2018.

19.4.2018.

Stribild

Gilead Sciences International Limited

Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom

EU/1/13/830

23.4.2018.

19.4.2018.

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/16/1157

23.4.2018.

19.4.2018.

Sutent

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/347

23.4.2018.

19.4.2018.

Volibris

Glaxo Group Ltd

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

EU/1/08/451

23.4.2018.

19.4.2018.

Xadago

Zambon S.p.A.

Via Lillo del Duca 10, 20 091 Bresso (MI), Italia

EU/1/14/984

23.4.2018.

19.4.2018.

Yargesa

JensonR+ Limited

Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom

EU/1/17/1176

23.4.2018.

23.4.2018.

Aerinaze

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/399

25.4.2018.

23.4.2018.

Bosulif

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/13/818

25.4.2018.

23.4.2018.

Daxas

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/10/636

25.4.2018.

23.4.2018.

Desloratadine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/745

25.4.2018.

23.4.2018.

Duloxetine Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1028

25.4.2018.

23.4.2018.

Emadine

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/095

25.4.2018.

23.4.2018.

Entresto

Novartis Europharm Limited

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

EU/1/15/1058

25.4.2018.

23.4.2018.

Eucreas

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/425

25.4.2018.

23.4.2018.

Exelon

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/98/066

25.4.2018.

23.4.2018.

Fycompa

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/12/776

25.4.2018.

23.4.2018.

GILENYA

Novartis Europharm Limited

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

EU/1/11/677

25.4.2018.

23.4.2018.

Humira

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

25.4.2018.

23.4.2018.

Hycamtin

Novartis Europharm Limited

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

EU/1/96/027

25.4.2018.

23.4.2018.

Imnovid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

25.4.2018.

23.4.2018.

Imvanex

Bavarian Nordic A/S

Hejreskovvej 10a, 3490 Kvistgaard, Danmark

EU/1/13/855

25.4.2018.

23.4.2018.

Lojuxta

Aegerion Pharmaceuticals Limited

Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom

EU/1/13/851

25.4.2018.

23.4.2018.

NeuroBloc

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/00/166

25.4.2018.

23.4.2018.

Nevanac

Novartis Europharm Limited

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

EU/1/07/433

25.4.2018.

23.4.2018.

Onbrez Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/593

25.4.2018.

23.4.2018.

Opdivo

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/15/1014

25.4.2018.

23.4.2018.

Pregabalin Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1021

25.4.2018.

23.4.2018.

Spedra

Menarini International Operations Luxembourg S.A.

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

EU/1/13/841

25.4.2018.

23.4.2018.

TOBI Podhaler

Novartis Europharm Limited

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

EU/1/10/652

25.4.2018.

23.4.2018.

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200

25.4.2018.

23.4.2018.

Zydelig

Gilead Sciences International Limited

Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom

EU/1/14/938

25.4.2018.

23.4.2018.

Zykadia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

25.4.2018.

26.4.2018.

Aloxi

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/04/306

30.4.2018.

26.4.2018.

Avonex

Biogen Idec Limited

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

EU/1/97/033

30.4.2018.

26.4.2018.

Cosentyx

Novartis Europharm Limited

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

EU/1/14/980

30.4.2018.

26.4.2018.

Elonva

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/09/609

30.4.2018.

26.4.2018.

Firazyr

Shire Orphan Therapies GmbH

Friedrichstraße 149, 10117 Berlin, Deutschland

EU/1/08/461

30.4.2018.

26.4.2018.

Galvus

Novartis Europharm Limited

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

EU/1/07/414

30.4.2018.

26.4.2018.

Jalra

Novartis Europharm Limited

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

EU/1/08/485

30.4.2018.

26.4.2018.

Lucentis

Novartis Europharm Limited

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

EU/1/06/374

30.4.2018.

26.4.2018.

Maviret

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/17/1213

30.4.2018.

26.4.2018.

Tasigna

Novartis Europharm Limited

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

EU/1/07/422

30.4.2018.

26.4.2018.

Truxima

Celltrion Healthcare Hungary Kft.

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

EU/1/16/1167

2.5.2018.

26.4.2018.

Voncento

CSL Behring GmbH

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

EU/1/13/857

30.4.2018.

26.4.2018.

Xiliarx

Novartis Europharm Limited

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

EU/1/08/486

30.4.2018.

26.4.2018.

Xolair

Novartis Europharm Limited

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

EU/1/05/319

30.4.2018.

26.4.2018.

Zometa

Novartis Europharm Limited

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

EU/1/01/176

30.4.2018.

30.4.2018.

Avamys

Glaxo Group Ltd

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

EU/1/07/434

3.5.2018.

30.4.2018.

Clopidogrel Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/08/465

3.5.2018.

30.4.2018.

Entresto

Novartis Europharm Limited

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

EU/1/15/1058

3.5.2018.

30.4.2018.

Hemlibra

Roche Registration GmbH

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

EU/1/18/1271

3.5.2018.

30.4.2018.

Perjeta

Roche Registration GmbH

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

EU/1/13/813

3.5.2018.

30.4.2018.

Pramipexole Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/490

3.5.2018.

30.4.2018.

Remsima

Celltrion Healthcare Hungary Kft.

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

EU/1/13/853

3.5.2018.

30.4.2018.

Rydapt

Novartis Europharm Limited

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

EU/1/17/1218

3.5.2018.

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

—

Tirdzniecības atļaujas izsniegšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.4.2018. | Clevor | Ropinirols | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/2/17/222 | Acu pilieni, šķīdums | QN04BC04 | 17.4.2018. |

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

13.4.2018.

Clevor

Ropinirols

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/2/17/222

Acu pilieni, šķīdums

QN04BC04

17.4.2018.

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

—

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

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 4.4.2018. | Convenia | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/06/059 | 6.4.2018. |
| 4.4.2018. | Stronghold | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/99/014 | 6.4.2018. |
| 4.4.2018. | Zulvac 1 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/130 | 6.4.2018. |
| 4.4.2018. | Zulvac 1 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/131 | 6.4.2018. |
| 4.4.2018. | Zulvac 8 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/105 | 6.4.2018. |
| 6.4.2018. | Apoquel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/13/154 | 10.4.2018. |
| 6.4.2018. | Stronghold Plus | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/16/204 | 10.4.2018. |
| 11.4.2018. | Zulvac 8 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/104 | 13.4.2018. |
| 13.4.2018. | Equip WNV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/08/086 | 17.4.2018. |
| 13.4.2018. | ProZinc | Boehringer Ingelheim Vetmedica GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/2/13/152 | 17.4.2018. |
| 16.4.2018. | BTVPUR | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/10/113 | 18.4.2018. |
| 16.4.2018. | Equilis West Nile | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/13/151 | 18.4.2018. |
| 20.4.2018. | Meloxidolor | Le Vet Beheer B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | EU/2/13/148 | 24.4.2018. |
| 26.4.2018. | Naxcel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/05/053 | 30.4.2018. |
| 26.4.2018. | Onsior | Elanco Europe Ltd.
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/08/089 | 30.4.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

4.4.2018.

Convenia

Zoetis Belgium S.A.

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

EU/2/06/059

6.4.2018.

4.4.2018.

Stronghold

Zoetis Belgium S.A.

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

EU/2/99/014

6.4.2018.

4.4.2018.

Zulvac 1 Bovis

Zoetis Belgium S.A.

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

EU/2/11/130

6.4.2018.

4.4.2018.

Zulvac 1 Ovis

Zoetis Belgium S.A.

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

EU/2/11/131

6.4.2018.

4.4.2018.

Zulvac 8 Bovis

Zoetis Belgium S.A.

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

EU/2/09/105

6.4.2018.

6.4.2018.

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

10.4.2018.

6.4.2018.

Stronghold Plus

Zoetis Belgium S.A.

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

EU/2/16/204

10.4.2018.

11.4.2018.

Zulvac 8 Ovis

Zoetis Belgium S.A.

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

EU/2/09/104

13.4.2018.

13.4.2018.

Equip WNV

Zoetis Belgium S.A.

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

EU/2/08/086

17.4.2018.

13.4.2018.

ProZinc

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/2/13/152

17.4.2018.

16.4.2018.

BTVPUR

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/10/113

18.4.2018.

16.4.2018.

Equilis West Nile

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/151

18.4.2018.

20.4.2018.

Meloxidolor

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/13/148

24.4.2018.

26.4.2018.

Naxcel

Zoetis Belgium S.A.

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

EU/2/05/053

30.4.2018.

26.4.2018.

Onsior

Elanco Europe Ltd.

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/08/089

30.4.2018.

| — | Tirdzniecības atļaujas izņemšana no aprites (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004) |
| --- | --- |

—

Tirdzniecības atļaujas izņemšana no aprites (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 26.4.2018. | CERTIFECT | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/11/125 | 30.4.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

26.4.2018.

CERTIFECT

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/11/125

30.4.2018.

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

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

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