# Eiropas Savienības C 150/2018

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 150 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 61. gadagājums2018. gada 27. aprīlis |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 150

Izdevums latviešu valodā

Informācija un paziņojumi

61. gadagājums2018. gada 27. aprīlis

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| Paziņojums Nr. | Saturs | Lappuse |
| --- | --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2018/C 150/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. marta līdz 2018. gada 31. martam(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu) | 1 |

Paziņojums Nr.

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2018/C 150/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. marta līdz 2018. gada 31. martam(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

| 27.4.2018 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 150/1 |
| --- | --- | --- | --- |

27.4.2018

LV

Eiropas Savienības Oficiālais Vēstnesis

C 150/1

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. marta līdz 2018. gada 31. martam

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

(2018/C 150/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.3.2018. | Shingrix | Herpes zoster vakcīna (rekombinanta, ar adjuvantu) | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/18/1272 | Pulveris un suspensija injekciju suspensijas pagatavošanai | J07BK03 | 23.3.2018. |
| 21.3.2018. | Steglatro | ertugliflozīns | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1267 | Apvalkotās tabletes | A10BK04 | 23.3.2018. |
| 22.3.2018. | Lokelma | Nātrija cirkonija ciklosilikāts | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1173 | Pulveris iekšķīgi lietojamas suspensijas pagatavošanai | V03AE10 | 26.3.2018. |
| 23.3.2018. | Alofisel | Darvadstrocel | TiGenix S.A.U.
  C/Marconi 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, España | EU/1/17/1261 | Suspensija injekcijai | L04 | 27.3.2018. |
| 23.3.2018. | Lamzede | alfa velmanāze (Velmanase alfa) / Velmanase alfa | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/17/1258 | Pulveris infūziju šķīduma pagatavošanai | A16AB | 27.3.2018. |
| 23.3.2018. | Segluromet | ertugliflozīns/metformīna hidrohlorīds | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1265 | Apvalkotās tabletes | A10BD23 | 27.3.2018. |
| 23.3.2018. | Semglee | Insulīns, glargīna | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1270 | Šķīdums injekcijām pildspalvveida pilnšļircē | A10AE04 | 27.3.2018. |
| 23.3.2018. | Steglujan | ertugliflozīns/sitagliptīns | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1266 | Apvalkotās tabletes | A10BD24 | 27.3.2018. |

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

21.3.2018.

Shingrix

Herpes zoster vakcīna (rekombinanta, ar adjuvantu)

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

Pulveris un suspensija injekciju suspensijas pagatavošanai

J07BK03

23.3.2018.

21.3.2018.

Steglatro

ertugliflozīns

Merck Sharp & Dohme Limited

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

EU/1/18/1267

Apvalkotās tabletes

A10BK04

23.3.2018.

22.3.2018.

Lokelma

Nātrija cirkonija ciklosilikāts

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

Pulveris iekšķīgi lietojamas suspensijas pagatavošanai

V03AE10

26.3.2018.

23.3.2018.

Alofisel

Darvadstrocel

TiGenix S.A.U.

C/Marconi 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, España

EU/1/17/1261

Suspensija injekcijai

L04

27.3.2018.

23.3.2018.

Lamzede

alfa velmanāze (Velmanase alfa) / Velmanase alfa

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/17/1258

Pulveris infūziju šķīduma pagatavošanai

A16AB

27.3.2018.

23.3.2018.

Segluromet

ertugliflozīns/metformīna hidrohlorīds

Merck Sharp & Dohme Limited

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

EU/1/18/1265

Apvalkotās tabletes

A10BD23

27.3.2018.

23.3.2018.

Semglee

Insulīns, glargīna

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1270

Šķīdums injekcijām pildspalvveida pilnšļircē

A10AE04

27.3.2018.

23.3.2018.

Steglujan

ertugliflozīns/sitagliptīns

Merck Sharp & Dohme Limited

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

EU/1/18/1266

Apvalkotās tabletes

A10BD24

27.3.2018.

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

—

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 |
| --- | --- | --- | --- | --- |
| 1.3.2018. | Ameluz | Biofrontera Bioscience GmbH
  Hemmelrather Weg 201, 51377 Leverkusen, Deutschland | EU/1/11/740 | 5.3.2018. |
| 1.3.2018. | BiResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/921 | 5.3.2018. |
| 1.3.2018. | Galvus | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/414 | 5.3.2018. |
| 1.3.2018. | GONAL-f | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/95/001 | 5.3.2018. |
| 1.3.2018. | IDELVION | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/16/1095 | 5.3.2018. |
| 1.3.2018. | Insulatard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/233 | 5.3.2018. |
| 1.3.2018. | Jalra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/485 | 5.3.2018. |
| 1.3.2018. | Mixtard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/231 | 5.3.2018. |
| 1.3.2018. | Neparvis | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/16/1103 | 5.3.2018. |
| 1.3.2018. | Protaphane | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/234 | 5.3.2018. |
| 1.3.2018. | Xeplion | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/11/672 | 5.3.2018. |
| 1.3.2018. | Xiliarx | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/486 | 5.3.2018. |
| 5.3.2018. | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/447 | 7.3.2018. |
| 5.3.2018. | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005 | 7.3.2018. |
| 5.3.2018. | Epivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/96/015 | 7.3.2018. |
| 5.3.2018. | Hizentra | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/11/687 | 7.3.2018. |
| 5.3.2018. | Myclausen | Passauer Pharma GmbH
  Eiderstedter Weg 3, 14129 Berlin, Deutschland | EU/1/10/647 | 8.3.2018. |
| 5.3.2018. | Mycophenolate mofetil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/439 | 7.3.2018. |
| 5.3.2018. | Myfenax | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/438 | 7.3.2018. |
| 5.3.2018. | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/13/886 | 7.3.2018. |
| 5.3.2018. | Sirturo | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/13/901 | 7.3.2018. |
| 5.3.2018. | Terrosa | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/16/1159 | 7.3.2018. |
| 5.3.2018. | Viekirax | AbbVie Ltd
  Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom | EU/1/14/982 | 7.3.2018. |
| 5.3.2018. | Zydelig | Gilead Sciences International Limited
  Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom | EU/1/14/938 | 7.3.2018. |
| 7.3.2018. | Aclasta | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/308 | 9.3.2018. |
| 7.3.2018. | Adempas | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/907 | 9.3.2018. |
| 7.3.2018. | Kisplyx | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/16/1128 | 9.3.2018. |
| 7.3.2018. | Levetiracetam Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/11/713 | 9.3.2018. |
| 7.3.2018. | Litak | Lipomed GmbH
  Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland | EU/1/04/275 | 9.3.2018. |
| 7.3.2018. | Lonsurf | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes CEDEX, France | EU/1/16/1096 | 9.3.2018. |
| 7.3.2018. | Pregabalin Pfizer | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/916 | 9.3.2018. |
| 7.3.2018. | PritorPlus | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/02/215 | 9.3.2018. |
| 7.3.2018. | Raplixa | Mallinckrodt Pharmaceuticals Ireland Limited
  College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland | EU/1/14/985 | 9.3.2018. |
| 7.3.2018. | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/929 | 9.3.2018. |
| 7.3.2018. | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 9.3.2018. |
| 12.3.2018. | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005 | 14.3.2018. |
| 12.3.2018. | DuoResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/920 | 14.3.2018. |
| 12.3.2018. | Latuda | Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.
  Viale Amelia 70, 00181 Roma, Italia | EU/1/14/913 | 14.3.2018. |
| 12.3.2018. | MicardisPlus | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/02/213 | 14.3.2018. |
| 12.3.2018. | Neuraceq | Piramal Imaging Limited
  Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom | EU/1/13/906 | 14.3.2018. |
| 12.3.2018. | Oprymea | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/469 | 15.3.2018. |
| 12.3.2018. | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 14.3.2018. |
| 15.3.2018. | Alecensa | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/16/1169 | 19.3.2018. |
| 15.3.2018. | Erivedge | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/848 | 19.3.2018. |
| 15.3.2018. | Humira | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/03/256 | 19.3.2018. |
| 15.3.2018. | NeoRecormon | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/97/031 | 19.3.2018. |
| 15.3.2018. | Pegasys | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/02/221 | 19.3.2018. |
| 15.3.2018. | Vaxelis | MCM Vaccine B.V.
  Robert Boyleweg 4, 2333 CG Leiden, Nederland | EU/1/15/1079 | 19.3.2018. |
| 16.3.2018. | Aripiprazole Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1029 | 20.3.2018. |
| 16.3.2018. | Avastin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/04/300 | 20.3.2018. |
| 16.3.2018. | Cetrotide | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/99/100 | 22.3.2018. |
| 16.3.2018. | Cotellic | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/15/1048 | 20.3.2018. |
| 16.3.2018. | Glyxambi | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/16/1146 | 20.3.2018. |
| 16.3.2018. | Herceptin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/145 | 20.3.2018. |
| 16.3.2018. | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/08/507 | 20.3.2018. |
| 16.3.2018. | Integrilin | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/99/109 | 20.3.2018. |
| 16.3.2018. | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 20.3.2018. |
| 16.3.2018. | Kadcyla | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/885 | 20.3.2018. |
| 16.3.2018. | Kinzalkomb | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/02/214 | 20.3.2018. |
| 16.3.2018. | Mabthera | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/98/067 | 21.3.2018. |
| 16.3.2018. | Mircera | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/07/400 | 20.3.2018. |
| 16.3.2018. | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 21.3.2018. |
| 16.3.2018. | Vaniqa | Almirall, S.A.
  Ronda General Mitre, 151, 08022 Barcelona, España | EU/1/01/173 | 20.3.2018. |
| 16.3.2018. | Xeloda | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/163 | 20.3.2018. |
| 16.3.2018. | Zomarist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/483 | 20.3.2018. |
| 19.3.2018. | Xofigo | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/873 | 21.3.2018. |
| 20.3.2018. | Invirase | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026 | 22.3.2018. |
| 21.3.2018. | Aripiprazole Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1009 | 23.3.2018. |
| 21.3.2018. | Faslodex | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/03/269 | 23.3.2018. |
| 21.3.2018. | OCALIVA | Intercept Pharma Ltd
  2 Pancras Square, London N1C 4AG, United Kingdom | EU/1/16/1139 | 23.3.2018. |
| 21.3.2018. | PHEBURANE | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/13/822 | 23.3.2018. |
| 21.3.2018. | Pixuvri | CTI Life Sciences Ltd
  Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 23.3.2018. |
| 21.3.2018. | Vibativ | Theravance Biopharma Ireland Limited
  Connaught House 1, Burlington Road, Fourth Floor, D04 C5Y6 Dublin 4, Ireland | EU/1/11/705 | 23.3.2018. |
| 23.3.2018. | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | EU/1/07/430 | 27.3.2018. |
| 23.3.2018. | Blincyto | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | 27.3.2018. |
| 23.3.2018. | Feraccru | Shield TX (UK) Limited
  Gateshead Quays, NE8 3DF, United Kingdom | EU/1/15/1075 | 27.3.2018. |
| 23.3.2018. | Invirase | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026 | 27.3.2018. |
| 23.3.2018. | Isentress | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/436 | 27.3.2018. |
| 23.3.2018. | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 27.3.2018. |
| 23.3.2018. | Nuwiq | Octapharma AB
  Lars Forssells gata 23, 112 75 Stockholm, Sverige | EU/1/14/936 | 27.3.2018. |
| 23.3.2018. | Ocrevus | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1231 | 27.3.2018. |
| 23.3.2018. | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 27.3.2018. |
| 23.3.2018. | Perjeta | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/813 | 27.3.2018. |
| 23.3.2018. | Pixuvri | CTI Life Sciences Ltd
  Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 27.3.2018. |
| 23.3.2018. | Torisel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/424 | 27.3.2018. |
| 23.3.2018. | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 27.3.2018. |
| 27.3.2018. | EndolucinBeta | ITG Isotope Technologies Garching GmbH
  Lichtenbergstraße 1, 85748 Garching, Deutschland | EU/1/16/1105 | 29.3.2018. |
| 27.3.2018. | Ganfort | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/06/340 | 29.3.2018. |
| 27.3.2018. | Xgeva | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/11/703 | 29.3.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

1.3.2018.

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, 51377 Leverkusen, Deutschland

EU/1/11/740

5.3.2018.

1.3.2018.

BiResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/921

5.3.2018.

1.3.2018.

Galvus

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/414

5.3.2018.

1.3.2018.

GONAL-f

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/95/001

5.3.2018.

1.3.2018.

IDELVION

CSL Behring GmbH

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

EU/1/16/1095

5.3.2018.

1.3.2018.

Insulatard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/233

5.3.2018.

1.3.2018.

Jalra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/485

5.3.2018.

1.3.2018.

Mixtard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/231

5.3.2018.

1.3.2018.

Neparvis

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/16/1103

5.3.2018.

1.3.2018.

Protaphane

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/234

5.3.2018.

1.3.2018.

Xeplion

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/672

5.3.2018.

1.3.2018.

Xiliarx

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/486

5.3.2018.

5.3.2018.

Adenuric

Menarini International Operations Luxembourg S.A.

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

EU/1/08/447

7.3.2018.

5.3.2018.

CellCept

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/005

7.3.2018.

5.3.2018.

Epivir

ViiV Healthcare UK Limited

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

EU/1/96/015

7.3.2018.

5.3.2018.

Hizentra

CSL Behring GmbH

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

EU/1/11/687

7.3.2018.

5.3.2018.

Myclausen

Passauer Pharma GmbH

Eiderstedter Weg 3, 14129 Berlin, Deutschland

EU/1/10/647

8.3.2018.

5.3.2018.

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

7.3.2018.

5.3.2018.

Myfenax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/438

7.3.2018.

5.3.2018.

Relvar Ellipta

Glaxo Group Ltd

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

EU/1/13/886

7.3.2018.

5.3.2018.

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

7.3.2018.

5.3.2018.

Terrosa

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/16/1159

7.3.2018.

5.3.2018.

Viekirax

AbbVie Ltd

Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom

EU/1/14/982

7.3.2018.

5.3.2018.

Zydelig

Gilead Sciences International Limited

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

EU/1/14/938

7.3.2018.

7.3.2018.

Aclasta

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/308

9.3.2018.

7.3.2018.

Adempas

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/907

9.3.2018.

7.3.2018.

Kisplyx

Eisai Europe Limited

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

EU/1/16/1128

9.3.2018.

7.3.2018.

Levetiracetam Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/713

9.3.2018.

7.3.2018.

Litak

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/04/275

9.3.2018.

7.3.2018.

Lonsurf

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/16/1096

9.3.2018.

7.3.2018.

Pregabalin Pfizer

Pfizer Limited

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

EU/1/14/916

9.3.2018.

7.3.2018.

PritorPlus

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/215

9.3.2018.

7.3.2018.

Raplixa

Mallinckrodt Pharmaceuticals Ireland Limited

College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland

EU/1/14/985

9.3.2018.

7.3.2018.

Revinty Ellipta

Glaxo Group Ltd

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

EU/1/14/929

9.3.2018.

7.3.2018.

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

9.3.2018.

12.3.2018.

CellCept

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/005

14.3.2018.

12.3.2018.

DuoResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/920

14.3.2018.

12.3.2018.

Latuda

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

Viale Amelia 70, 00181 Roma, Italia

EU/1/14/913

14.3.2018.

12.3.2018.

MicardisPlus

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/02/213

14.3.2018.

12.3.2018.

Neuraceq

Piramal Imaging Limited

Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom

EU/1/13/906

14.3.2018.

12.3.2018.

Oprymea

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/469

15.3.2018.

12.3.2018.

Trajenta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/11/707

14.3.2018.

15.3.2018.

Alecensa

Roche Registration GmbH

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

EU/1/16/1169

19.3.2018.

15.3.2018.

Erivedge

Roche Registration GmbH

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

EU/1/13/848

19.3.2018.

15.3.2018.

Humira

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

19.3.2018.

15.3.2018.

NeoRecormon

Roche Registration GmbH

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

EU/1/97/031

19.3.2018.

15.3.2018.

Pegasys

Roche Registration GmbH

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

EU/1/02/221

19.3.2018.

15.3.2018.

Vaxelis

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

19.3.2018.

16.3.2018.

Aripiprazole Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1029

20.3.2018.

16.3.2018.

Avastin

Roche Registration GmbH

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

EU/1/04/300

20.3.2018.

16.3.2018.

Cetrotide

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/99/100

22.3.2018.

16.3.2018.

Cotellic

Roche Registration GmbH

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

EU/1/15/1048

20.3.2018.

16.3.2018.

Glyxambi

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/16/1146

20.3.2018.

16.3.2018.

Herceptin

Roche Registration GmbH

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

EU/1/00/145

20.3.2018.

16.3.2018.

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/08/507

20.3.2018.

16.3.2018.

Integrilin

Glaxo Group Ltd

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

EU/1/99/109

20.3.2018.

16.3.2018.

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

20.3.2018.

16.3.2018.

Kadcyla

Roche Registration GmbH

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

EU/1/13/885

20.3.2018.

16.3.2018.

Kinzalkomb

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214

20.3.2018.

16.3.2018.

Mabthera

Roche Registration GmbH

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

EU/1/98/067

21.3.2018.

16.3.2018.

Mircera

Roche Registration GmbH

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

EU/1/07/400

20.3.2018.

16.3.2018.

Silgard

Merck Sharp & Dohme Limited

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

EU/1/06/358

21.3.2018.

16.3.2018.

Vaniqa

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/01/173

20.3.2018.

16.3.2018.

Xeloda

Roche Registration GmbH

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

EU/1/00/163

20.3.2018.

16.3.2018.

Zomarist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/483

20.3.2018.

19.3.2018.

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

21.3.2018.

20.3.2018.

Invirase

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/026

22.3.2018.

21.3.2018.

Aripiprazole Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1009

23.3.2018.

21.3.2018.

Faslodex

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/03/269

23.3.2018.

21.3.2018.

OCALIVA

Intercept Pharma Ltd

2 Pancras Square, London N1C 4AG, United Kingdom

EU/1/16/1139

23.3.2018.

21.3.2018.

PHEBURANE

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/822

23.3.2018.

21.3.2018.

Pixuvri

CTI Life Sciences Ltd

Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

23.3.2018.

21.3.2018.

Vibativ

Theravance Biopharma Ireland Limited

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

EU/1/11/705

23.3.2018.

23.3.2018.

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

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

EU/1/07/430

27.3.2018.

23.3.2018.

Blincyto

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

27.3.2018.

23.3.2018.

Feraccru

Shield TX (UK) Limited

Gateshead Quays, NE8 3DF, United Kingdom

EU/1/15/1075

27.3.2018.

23.3.2018.

Invirase

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/026

27.3.2018.

23.3.2018.

Isentress

Merck Sharp & Dohme Limited

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

EU/1/07/436

27.3.2018.

23.3.2018.

KEYTRUDA

Merck Sharp & Dohme Limited

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

EU/1/15/1024

27.3.2018.

23.3.2018.

Nuwiq

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/14/936

27.3.2018.

23.3.2018.

Ocrevus

Roche Registration GmbH

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

EU/1/17/1231

27.3.2018.

23.3.2018.

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

27.3.2018.

23.3.2018.

Perjeta

Roche Registration GmbH

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

EU/1/13/813

27.3.2018.

23.3.2018.

Pixuvri

CTI Life Sciences Ltd

Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

27.3.2018.

23.3.2018.

Torisel

Pfizer Limited

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

EU/1/07/424

27.3.2018.

23.3.2018.

Translarna

PTC Therapeutics International Limited

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

EU/1/13/902

27.3.2018.

27.3.2018.

EndolucinBeta

ITG Isotope Technologies Garching GmbH

Lichtenbergstraße 1, 85748 Garching, Deutschland

EU/1/16/1105

29.3.2018.

27.3.2018.

Ganfort

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/06/340

29.3.2018.

27.3.2018.

Xgeva

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

29.3.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 5.3.2018. | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/924 | 7.3.2018. |
| 19.3.2018. | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/08/507 | 21.3.2018. |
| 23.3.2018. | Vibativ | Theravance Biopharma Ireland Limited
  Connaught House 1, Burlington Road, Fourth Floor, D04 C5Y6 Dublin 4, Ireland | EU/1/11/705 | 27.3.2018. |
| 27.3.2018. | Raplixa | Mallinckrodt Pharmaceuticals Ireland Limited
  College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland | EU/1/14/985 | 29.3.2018. |
| 27.3.2018. | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 29.3.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

5.3.2018.

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/924

7.3.2018.

19.3.2018.

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/08/507

21.3.2018.

23.3.2018.

Vibativ

Theravance Biopharma Ireland Limited

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

EU/1/11/705

27.3.2018.

27.3.2018.

Raplixa

Mallinckrodt Pharmaceuticals Ireland Limited

College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland

EU/1/14/985

29.3.2018.

27.3.2018.

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

29.3.2018.

| — | Tirdzniecības atļaujas atlikšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 20. pants) |
| --- | --- |

—

Tirdzniecības atļaujas atlikšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 20. pants)

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 8.3.2018. | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 12.3.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

8.3.2018.

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

12.3.2018.

| — | 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 |
| --- | --- | --- | --- | --- |
| 19.3.2018. | Bravecto | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/13/158 | 21.3.2018. |
| 19.3.2018. | Metacam | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/97/004 | 21.3.2018. |
| 19.3.2018. | Porcilis PCV ID | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/15/187 | 21.3.2018. |
| 20.3.2018. | ECOPORC SHIGA | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/13/149 | 22.3.2018. |
| 20.3.2018. | Oncept IL-2 | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/150 | 22.3.2018. |
| 20.3.2018. | Panacur AquaSol | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/11/135 | 22.3.2018. |
| 22.3.2018. | Draxxin | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/03/041 | 26.3.2018. |
| 22.3.2018. | ERAVAC | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/16/199 | 26.3.2018. |
| 22.3.2018. | Palladia | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/100 | 26.3.2018. |
| 22.3.2018. | Suvaxyn CSF Marker | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/179 | 26.3.2018. |
| 22.3.2018. | Suvaxyn PCV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/099 | 26.3.2018. |
| 27.3.2018. | Versican Plus DHPPi | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/169 | 29.3.2018. |
| 27.3.2018. | Versican Plus DHPPi/L4 | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/164 | 29.3.2018. |
| 27.3.2018. | Versican Plus DHPPi/L4R | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/163 | 29.3.2018. |
| 27.3.2018. | Zulvac 1+8 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/139 | 29.3.2018. |
| 27.3.2018. | Zulvac 1+8 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/120 | 29.3.2018. |
| 27.3.2018. | Zulvac SBV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/178 | 29.3.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

19.3.2018.

Bravecto

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/158

21.3.2018.

19.3.2018.

Metacam

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

21.3.2018.

19.3.2018.

Porcilis PCV ID

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/187

21.3.2018.

20.3.2018.

ECOPORC SHIGA

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/13/149

22.3.2018.

20.3.2018.

Oncept IL-2

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/150

22.3.2018.

20.3.2018.

Panacur AquaSol

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/135

22.3.2018.

22.3.2018.

Draxxin

Zoetis Belgium S.A.

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

EU/2/03/041

26.3.2018.

22.3.2018.

ERAVAC

Laboratorios Hipra, S.A.

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

EU/2/16/199

26.3.2018.

22.3.2018.

Palladia

Zoetis Belgium S.A.

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

EU/2/09/100

26.3.2018.

22.3.2018.

Suvaxyn CSF Marker

Zoetis Belgium S.A.

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

EU/2/14/179

26.3.2018.

22.3.2018.

Suvaxyn PCV

Zoetis Belgium S.A.

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

EU/2/09/099

26.3.2018.

27.3.2018.

Versican Plus DHPPi

Zoetis Belgium S.A.

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

EU/2/14/169

29.3.2018.

27.3.2018.

Versican Plus DHPPi/L4

Zoetis Belgium S.A.

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

EU/2/14/164

29.3.2018.

27.3.2018.

Versican Plus DHPPi/L4R

Zoetis Belgium S.A.

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

EU/2/14/163

29.3.2018.

27.3.2018.

Zulvac 1+8 Bovis

Zoetis Belgium S.A.

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

EU/2/12/139

29.3.2018.

27.3.2018.

Zulvac 1+8 Ovis

Zoetis Belgium S.A.

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

EU/2/11/120

29.3.2018.

27.3.2018.

Zulvac SBV

Zoetis Belgium S.A.

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

EU/2/14/178

29.3.2018.

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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