# Europos Sąjungos C 150/2018

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 150 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 61 metai2018m. balandžio 27d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 150

Leidimas lietuvių kalba

Informacija ir pranešimai

61 metai2018m. balandžio 27d.

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| Pranešimo Nr. | Turinys | Puslapis |
| --- | --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2018/C 150/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. kovo 1 d. iki 2018 m. kovo 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 1 |

Pranešimo Nr.

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2018/C 150/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. kovo 1 d. iki 2018 m. kovo 31 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

1

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| LT | |
| --- | --- |

LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 27.4.2018 | LT | Europos Sąjungos oficialusis leidinys | C 150/1 |
| --- | --- | --- | --- |

27.4.2018

LT

Europos Sąjungos oficialusis leidinys

C 150/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. kovo 1 d. iki 2018 m. kovo 31 d.

(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 (1) 13 straipsnį arba 38 straipsnį)

(2018/C 150/01)

| — | Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta |
| --- | --- |

—

Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2018 3 21 | Shingrix | Herpes zoster vakcina (rekombinantinė, su adjuvantu) | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/18/1272 | Milteliai ir suspensija injekcinei suspensijai | J07BK03 | 2018 3 23 |
| 2018 3 21 | Steglatro | ertugliflozinas | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1267 | Plėvele dengta tabletė | A10BK04 | 2018 3 23 |
| 2018 3 22 | Lokelma | Cirkonio ciklosilikato natrio druska | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1173 | Milteliai geriamai suspensijai | V03AE10 | 2018 3 26 |
| 2018 3 23 | Alofisel | Darvadstrocelis | TiGenix S.A.U.
  C/Marconi 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, España | EU/1/17/1261 | Injekcinė suspensija | L04 | 2018 3 27 |
| 2018 3 23 | Lamzede | velmanazė alfa | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/17/1258 | Milteliai infuziniam tirpalui | A16AB | 2018 3 27 |
| 2018 3 23 | Segluromet | ertugliflozinas/metformino hidrochloridas | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1265 | Plėvele dengta tabletė | A10BD23 | 2018 3 27 |
| 2018 3 23 | Semglee | Insulinas glarginas | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1270 | Injekcinis tirpalas užpildytoje švirkštimo priemonėje | A10AE04 | 2018 3 27 |
| 2018 3 23 | Steglujan | ertugliflozinas/sitagliptinas | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1266 | Plėvele dengta tabletė | A10BD24 | 2018 3 27 |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2018 3 21

Shingrix

Herpes zoster vakcina (rekombinantinė, su adjuvantu)

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

Milteliai ir suspensija injekcinei suspensijai

J07BK03

2018 3 23

2018 3 21

Steglatro

ertugliflozinas

Merck Sharp & Dohme Limited

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

EU/1/18/1267

Plėvele dengta tabletė

A10BK04

2018 3 23

2018 3 22

Lokelma

Cirkonio ciklosilikato natrio druska

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

Milteliai geriamai suspensijai

V03AE10

2018 3 26

2018 3 23

Alofisel

Darvadstrocelis

TiGenix S.A.U.

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

EU/1/17/1261

Injekcinė suspensija

L04

2018 3 27

2018 3 23

Lamzede

velmanazė alfa

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/17/1258

Milteliai infuziniam tirpalui

A16AB

2018 3 27

2018 3 23

Segluromet

ertugliflozinas/metformino hidrochloridas

Merck Sharp & Dohme Limited

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

EU/1/18/1265

Plėvele dengta tabletė

A10BD23

2018 3 27

2018 3 23

Semglee

Insulinas glarginas

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1270

Injekcinis tirpalas užpildytoje švirkštimo priemonėje

A10AE04

2018 3 27

2018 3 23

Steglujan

ertugliflozinas/sitagliptinas

Merck Sharp & Dohme Limited

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

EU/1/18/1266

Plėvele dengta tabletė

A10BD24

2018 3 27

| — | Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta |
| --- | --- |

—

Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2018 3 1 | Ameluz | Biofrontera Bioscience GmbH
  Hemmelrather Weg 201, 51377 Leverkusen, Deutschland | EU/1/11/740 | 2018 3 5 |
| 2018 3 1 | BiResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/921 | 2018 3 5 |
| 2018 3 1 | Galvus | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/414 | 2018 3 5 |
| 2018 3 1 | GONAL-f | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/95/001 | 2018 3 5 |
| 2018 3 1 | IDELVION | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/16/1095 | 2018 3 5 |
| 2018 3 1 | Insulatard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/233 | 2018 3 5 |
| 2018 3 1 | Jalra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/485 | 2018 3 5 |
| 2018 3 1 | Mixtard | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/231 | 2018 3 5 |
| 2018 3 1 | Neparvis | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/16/1103 | 2018 3 5 |
| 2018 3 1 | Protaphane | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/02/234 | 2018 3 5 |
| 2018 3 1 | Xeplion | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/11/672 | 2018 3 5 |
| 2018 3 1 | Xiliarx | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/486 | 2018 3 5 |
| 2018 3 5 | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/447 | 2018 3 7 |
| 2018 3 5 | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005 | 2018 3 7 |
| 2018 3 5 | Epivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/96/015 | 2018 3 7 |
| 2018 3 5 | Hizentra | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/11/687 | 2018 3 7 |
| 2018 3 5 | Myclausen | Passauer Pharma GmbH
  Eiderstedter Weg 3, 14129 Berlin, Deutschland | EU/1/10/647 | 2018 3 8 |
| 2018 3 5 | Mycophenolate mofetil Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/439 | 2018 3 7 |
| 2018 3 5 | Myfenax | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/438 | 2018 3 7 |
| 2018 3 5 | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/13/886 | 2018 3 7 |
| 2018 3 5 | Sirturo | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/13/901 | 2018 3 7 |
| 2018 3 5 | Terrosa | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/16/1159 | 2018 3 7 |
| 2018 3 5 | Viekirax | AbbVie Ltd
  Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom | EU/1/14/982 | 2018 3 7 |
| 2018 3 5 | Zydelig | Gilead Sciences International Limited
  Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom | EU/1/14/938 | 2018 3 7 |
| 2018 3 7 | Aclasta | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/308 | 2018 3 9 |
| 2018 3 7 | Adempas | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/907 | 2018 3 9 |
| 2018 3 7 | Kisplyx | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/16/1128 | 2018 3 9 |
| 2018 3 7 | Levetiracetam Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/11/713 | 2018 3 9 |
| 2018 3 7 | Litak | Lipomed GmbH
  Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland | EU/1/04/275 | 2018 3 9 |
| 2018 3 7 | Lonsurf | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes CEDEX, France | EU/1/16/1096 | 2018 3 9 |
| 2018 3 7 | Pregabalin Pfizer | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/916 | 2018 3 9 |
| 2018 3 7 | PritorPlus | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/02/215 | 2018 3 9 |
| 2018 3 7 | Raplixa | Mallinckrodt Pharmaceuticals Ireland Limited
  College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland | EU/1/14/985 | 2018 3 9 |
| 2018 3 7 | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/929 | 2018 3 9 |
| 2018 3 7 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 2018 3 9 |
| 2018 3 12 | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005 | 2018 3 14 |
| 2018 3 12 | DuoResp Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/920 | 2018 3 14 |
| 2018 3 12 | Latuda | Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.
  Viale Amelia 70, 00181 Roma, Italia | EU/1/14/913 | 2018 3 14 |
| 2018 3 12 | MicardisPlus | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/02/213 | 2018 3 14 |
| 2018 3 12 | Neuraceq | Piramal Imaging Limited
  Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom | EU/1/13/906 | 2018 3 14 |
| 2018 3 12 | Oprymea | Krka d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/469 | 2018 3 15 |
| 2018 3 12 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 2018 3 14 |
| 2018 3 15 | Alecensa | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/16/1169 | 2018 3 19 |
| 2018 3 15 | Erivedge | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/848 | 2018 3 19 |
| 2018 3 15 | Humira | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/03/256 | 2018 3 19 |
| 2018 3 15 | NeoRecormon | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/97/031 | 2018 3 19 |
| 2018 3 15 | Pegasys | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/02/221 | 2018 3 19 |
| 2018 3 15 | Vaxelis | MCM Vaccine B.V.
  Robert Boyleweg 4, 2333 CG Leiden, Nederland | EU/1/15/1079 | 2018 3 19 |
| 2018 3 16 | Aripiprazole Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1029 | 2018 3 20 |
| 2018 3 16 | Avastin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/04/300 | 2018 3 20 |
| 2018 3 16 | Cetrotide | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/99/100 | 2018 3 22 |
| 2018 3 16 | Cotellic | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/15/1048 | 2018 3 20 |
| 2018 3 16 | Glyxambi | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/16/1146 | 2018 3 20 |
| 2018 3 16 | Herceptin | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/145 | 2018 3 20 |
| 2018 3 16 | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/08/507 | 2018 3 20 |
| 2018 3 16 | Integrilin | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/99/109 | 2018 3 20 |
| 2018 3 16 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 2018 3 20 |
| 2018 3 16 | Kadcyla | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/885 | 2018 3 20 |
| 2018 3 16 | Kinzalkomb | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/02/214 | 2018 3 20 |
| 2018 3 16 | Mabthera | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/98/067 | 2018 3 21 |
| 2018 3 16 | Mircera | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/07/400 | 2018 3 20 |
| 2018 3 16 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 2018 3 21 |
| 2018 3 16 | Vaniqa | Almirall, S.A.
  Ronda General Mitre, 151, 08022 Barcelona, España | EU/1/01/173 | 2018 3 20 |
| 2018 3 16 | Xeloda | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/00/163 | 2018 3 20 |
| 2018 3 16 | Zomarist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/483 | 2018 3 20 |
| 2018 3 19 | Xofigo | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/13/873 | 2018 3 21 |
| 2018 3 20 | Invirase | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026 | 2018 3 22 |
| 2018 3 21 | Aripiprazole Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1009 | 2018 3 23 |
| 2018 3 21 | Faslodex | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/03/269 | 2018 3 23 |
| 2018 3 21 | OCALIVA | Intercept Pharma Ltd
  2 Pancras Square, London N1C 4AG, United Kingdom | EU/1/16/1139 | 2018 3 23 |
| 2018 3 21 | PHEBURANE | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/13/822 | 2018 3 23 |
| 2018 3 21 | Pixuvri | CTI Life Sciences Ltd
  Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 2018 3 23 |
| 2018 3 21 | Vibativ | Theravance Biopharma Ireland Limited
  Connaught House 1, Burlington Road, Fourth Floor, D04 C5Y6 Dublin 4, Ireland | EU/1/11/705 | 2018 3 23 |
| 2018 3 23 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | EU/1/07/430 | 2018 3 27 |
| 2018 3 23 | Blincyto | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1047 | 2018 3 27 |
| 2018 3 23 | Feraccru | Shield TX (UK) Limited
  Gateshead Quays, NE8 3DF, United Kingdom | EU/1/15/1075 | 2018 3 27 |
| 2018 3 23 | Invirase | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026 | 2018 3 27 |
| 2018 3 23 | Isentress | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/436 | 2018 3 27 |
| 2018 3 23 | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 2018 3 27 |
| 2018 3 23 | Nuwiq | Octapharma AB
  Lars Forssells gata 23, 112 75 Stockholm, Sverige | EU/1/14/936 | 2018 3 27 |
| 2018 3 23 | Ocrevus | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1231 | 2018 3 27 |
| 2018 3 23 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 2018 3 27 |
| 2018 3 23 | Perjeta | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/13/813 | 2018 3 27 |
| 2018 3 23 | Pixuvri | CTI Life Sciences Ltd
  Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 2018 3 27 |
| 2018 3 23 | Torisel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/424 | 2018 3 27 |
| 2018 3 23 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 2018 3 27 |
| 2018 3 27 | EndolucinBeta | ITG Isotope Technologies Garching GmbH
  Lichtenbergstraße 1, 85748 Garching, Deutschland | EU/1/16/1105 | 2018 3 29 |
| 2018 3 27 | Ganfort | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/06/340 | 2018 3 29 |
| 2018 3 27 | Xgeva | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/11/703 | 2018 3 29 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 3 1

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, 51377 Leverkusen, Deutschland

EU/1/11/740

2018 3 5

2018 3 1

BiResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/921

2018 3 5

2018 3 1

Galvus

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/414

2018 3 5

2018 3 1

GONAL-f

Merck Serono Europe Limited

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

EU/1/95/001

2018 3 5

2018 3 1

IDELVION

CSL Behring GmbH

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

EU/1/16/1095

2018 3 5

2018 3 1

Insulatard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/233

2018 3 5

2018 3 1

Jalra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/485

2018 3 5

2018 3 1

Mixtard

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/231

2018 3 5

2018 3 1

Neparvis

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/16/1103

2018 3 5

2018 3 1

Protaphane

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/02/234

2018 3 5

2018 3 1

Xeplion

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/672

2018 3 5

2018 3 1

Xiliarx

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/486

2018 3 5

2018 3 5

Adenuric

Menarini International Operations Luxembourg S.A.

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

EU/1/08/447

2018 3 7

2018 3 5

CellCept

Roche Registration Limited

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

EU/1/96/005

2018 3 7

2018 3 5

Epivir

ViiV Healthcare UK Limited

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

EU/1/96/015

2018 3 7

2018 3 5

Hizentra

CSL Behring GmbH

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

EU/1/11/687

2018 3 7

2018 3 5

Myclausen

Passauer Pharma GmbH

Eiderstedter Weg 3, 14129 Berlin, Deutschland

EU/1/10/647

2018 3 8

2018 3 5

Mycophenolate mofetil Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/439

2018 3 7

2018 3 5

Myfenax

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/438

2018 3 7

2018 3 5

Relvar Ellipta

Glaxo Group Ltd

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

EU/1/13/886

2018 3 7

2018 3 5

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/901

2018 3 7

2018 3 5

Terrosa

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/16/1159

2018 3 7

2018 3 5

Viekirax

AbbVie Ltd

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

EU/1/14/982

2018 3 7

2018 3 5

Zydelig

Gilead Sciences International Limited

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

EU/1/14/938

2018 3 7

2018 3 7

Aclasta

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/308

2018 3 9

2018 3 7

Adempas

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/907

2018 3 9

2018 3 7

Kisplyx

Eisai Europe Limited

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

EU/1/16/1128

2018 3 9

2018 3 7

Levetiracetam Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/713

2018 3 9

2018 3 7

Litak

Lipomed GmbH

Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland

EU/1/04/275

2018 3 9

2018 3 7

Lonsurf

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/16/1096

2018 3 9

2018 3 7

Pregabalin Pfizer

Pfizer Limited

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

EU/1/14/916

2018 3 9

2018 3 7

PritorPlus

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/215

2018 3 9

2018 3 7

Raplixa

Mallinckrodt Pharmaceuticals Ireland Limited

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

EU/1/14/985

2018 3 9

2018 3 7

Revinty Ellipta

Glaxo Group Ltd

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

EU/1/14/929

2018 3 9

2018 3 7

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

2018 3 9

2018 3 12

CellCept

Roche Registration Limited

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

EU/1/96/005

2018 3 14

2018 3 12

DuoResp Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/920

2018 3 14

2018 3 12

Latuda

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

Viale Amelia 70, 00181 Roma, Italia

EU/1/14/913

2018 3 14

2018 3 12

MicardisPlus

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/02/213

2018 3 14

2018 3 12

Neuraceq

Piramal Imaging Limited

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

EU/1/13/906

2018 3 14

2018 3 12

Oprymea

Krka d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/469

2018 3 15

2018 3 12

Trajenta

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/11/707

2018 3 14

2018 3 15

Alecensa

Roche Registration GmbH

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

EU/1/16/1169

2018 3 19

2018 3 15

Erivedge

Roche Registration GmbH

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

EU/1/13/848

2018 3 19

2018 3 15

Humira

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/03/256

2018 3 19

2018 3 15

NeoRecormon

Roche Registration GmbH

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

EU/1/97/031

2018 3 19

2018 3 15

Pegasys

Roche Registration GmbH

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

EU/1/02/221

2018 3 19

2018 3 15

Vaxelis

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

2018 3 19

2018 3 16

Aripiprazole Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1029

2018 3 20

2018 3 16

Avastin

Roche Registration GmbH

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

EU/1/04/300

2018 3 20

2018 3 16

Cetrotide

Merck Serono Europe Limited

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

EU/1/99/100

2018 3 22

2018 3 16

Cotellic

Roche Registration GmbH

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

EU/1/15/1048

2018 3 20

2018 3 16

Glyxambi

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/16/1146

2018 3 20

2018 3 16

Herceptin

Roche Registration GmbH

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

EU/1/00/145

2018 3 20

2018 3 16

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/08/507

2018 3 20

2018 3 16

Integrilin

Glaxo Group Ltd

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

EU/1/99/109

2018 3 20

2018 3 16

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

2018 3 20

2018 3 16

Kadcyla

Roche Registration GmbH

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

EU/1/13/885

2018 3 20

2018 3 16

Kinzalkomb

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214

2018 3 20

2018 3 16

Mabthera

Roche Registration GmbH

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

EU/1/98/067

2018 3 21

2018 3 16

Mircera

Roche Registration GmbH

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

EU/1/07/400

2018 3 20

2018 3 16

Silgard

Merck Sharp & Dohme Limited

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

EU/1/06/358

2018 3 21

2018 3 16

Vaniqa

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/01/173

2018 3 20

2018 3 16

Xeloda

Roche Registration GmbH

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

EU/1/00/163

2018 3 20

2018 3 16

Zomarist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/483

2018 3 20

2018 3 19

Xofigo

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/13/873

2018 3 21

2018 3 20

Invirase

Roche Registration Limited

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

EU/1/96/026

2018 3 22

2018 3 21

Aripiprazole Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1009

2018 3 23

2018 3 21

Faslodex

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/03/269

2018 3 23

2018 3 21

OCALIVA

Intercept Pharma Ltd

2 Pancras Square, London N1C 4AG, United Kingdom

EU/1/16/1139

2018 3 23

2018 3 21

PHEBURANE

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/822

2018 3 23

2018 3 21

Pixuvri

CTI Life Sciences Ltd

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

EU/1/12/764

2018 3 23

2018 3 21

Vibativ

Theravance Biopharma Ireland Limited

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

EU/1/11/705

2018 3 23

2018 3 23

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

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

EU/1/07/430

2018 3 27

2018 3 23

Blincyto

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1047

2018 3 27

2018 3 23

Feraccru

Shield TX (UK) Limited

Gateshead Quays, NE8 3DF, United Kingdom

EU/1/15/1075

2018 3 27

2018 3 23

Invirase

Roche Registration Limited

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

EU/1/96/026

2018 3 27

2018 3 23

Isentress

Merck Sharp & Dohme Limited

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

EU/1/07/436

2018 3 27

2018 3 23

KEYTRUDA

Merck Sharp & Dohme Limited

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

EU/1/15/1024

2018 3 27

2018 3 23

Nuwiq

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/14/936

2018 3 27

2018 3 23

Ocrevus

Roche Registration GmbH

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

EU/1/17/1231

2018 3 27

2018 3 23

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

2018 3 27

2018 3 23

Perjeta

Roche Registration GmbH

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

EU/1/13/813

2018 3 27

2018 3 23

Pixuvri

CTI Life Sciences Ltd

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

EU/1/12/764

2018 3 27

2018 3 23

Torisel

Pfizer Limited

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

EU/1/07/424

2018 3 27

2018 3 23

Translarna

PTC Therapeutics International Limited

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

EU/1/13/902

2018 3 27

2018 3 27

EndolucinBeta

ITG Isotope Technologies Garching GmbH

Lichtenbergstraße 1, 85748 Garching, Deutschland

EU/1/16/1105

2018 3 29

2018 3 27

Ganfort

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/06/340

2018 3 29

2018 3 27

Xgeva

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/11/703

2018 3 29

| — | Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis) |
| --- | --- |

—

Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnis)

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2018 3 5 | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/924 | 2018 3 7 |
| 2018 3 19 | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, 69007 Lyon, France | EU/1/08/507 | 2018 3 21 |
| 2018 3 23 | Vibativ | Theravance Biopharma Ireland Limited
  Connaught House 1, Burlington Road, Fourth Floor, D04 C5Y6 Dublin 4, Ireland | EU/1/11/705 | 2018 3 27 |
| 2018 3 27 | Raplixa | Mallinckrodt Pharmaceuticals Ireland Limited
  College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland | EU/1/14/985 | 2018 3 29 |
| 2018 3 27 | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 2018 3 29 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 3 5

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/924

2018 3 7

2018 3 19

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, 69007 Lyon, France

EU/1/08/507

2018 3 21

2018 3 23

Vibativ

Theravance Biopharma Ireland Limited

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

EU/1/11/705

2018 3 27

2018 3 27

Raplixa

Mallinckrodt Pharmaceuticals Ireland Limited

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

EU/1/14/985

2018 3 29

2018 3 27

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

2018 3 29

| — | Rinkodaros leidimo sustabdymas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 20 straipsnis) |
| --- | --- |

—

Rinkodaros leidimo sustabdymas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 20 straipsnis)

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2018 3 8 | Zinbryta | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1107 | 2018 3 12 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 3 8

Zinbryta

Biogen Idec Limited

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

EU/1/16/1107

2018 3 12

| — | Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta |
| --- | --- |

—

Rinkodaros leidimo pakeitimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis): Priimta

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2018 3 19 | Bravecto | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/13/158 | 2018 3 21 |
| 2018 3 19 | Metacam | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/97/004 | 2018 3 21 |
| 2018 3 19 | Porcilis PCV ID | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/15/187 | 2018 3 21 |
| 2018 3 20 | ECOPORC SHIGA | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/13/149 | 2018 3 22 |
| 2018 3 20 | Oncept IL-2 | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/13/150 | 2018 3 22 |
| 2018 3 20 | Panacur AquaSol | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/11/135 | 2018 3 22 |
| 2018 3 22 | Draxxin | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/03/041 | 2018 3 26 |
| 2018 3 22 | ERAVAC | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/16/199 | 2018 3 26 |
| 2018 3 22 | Palladia | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/100 | 2018 3 26 |
| 2018 3 22 | Suvaxyn CSF Marker | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/179 | 2018 3 26 |
| 2018 3 22 | Suvaxyn PCV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/099 | 2018 3 26 |
| 2018 3 27 | Versican Plus DHPPi | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/169 | 2018 3 29 |
| 2018 3 27 | Versican Plus DHPPi/L4 | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/164 | 2018 3 29 |
| 2018 3 27 | Versican Plus DHPPi/L4R | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/163 | 2018 3 29 |
| 2018 3 27 | Zulvac 1+8 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/139 | 2018 3 29 |
| 2018 3 27 | Zulvac 1+8 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/120 | 2018 3 29 |
| 2018 3 27 | Zulvac SBV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/178 | 2018 3 29 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 3 19

Bravecto

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/158

2018 3 21

2018 3 19

Metacam

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

2018 3 21

2018 3 19

Porcilis PCV ID

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/15/187

2018 3 21

2018 3 20

ECOPORC SHIGA

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/13/149

2018 3 22

2018 3 20

Oncept IL-2

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/13/150

2018 3 22

2018 3 20

Panacur AquaSol

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/11/135

2018 3 22

2018 3 22

Draxxin

Zoetis Belgium S.A.

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

EU/2/03/041

2018 3 26

2018 3 22

ERAVAC

Laboratorios Hipra, S.A.

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

EU/2/16/199

2018 3 26

2018 3 22

Palladia

Zoetis Belgium S.A.

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

EU/2/09/100

2018 3 26

2018 3 22

Suvaxyn CSF Marker

Zoetis Belgium S.A.

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

EU/2/14/179

2018 3 26

2018 3 22

Suvaxyn PCV

Zoetis Belgium S.A.

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

EU/2/09/099

2018 3 26

2018 3 27

Versican Plus DHPPi

Zoetis Belgium S.A.

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

EU/2/14/169

2018 3 29

2018 3 27

Versican Plus DHPPi/L4

Zoetis Belgium S.A.

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

EU/2/14/164

2018 3 29

2018 3 27

Versican Plus DHPPi/L4R

Zoetis Belgium S.A.

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

EU/2/14/163

2018 3 29

2018 3 27

Zulvac 1+8 Bovis

Zoetis Belgium S.A.

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

EU/2/12/139

2018 3 29

2018 3 27

Zulvac 1+8 Ovis

Zoetis Belgium S.A.

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

EU/2/11/120

2018 3 29

2018 3 27

Zulvac SBV

Zoetis Belgium S.A.

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

EU/2/14/178

2018 3 29

Norintieji susipažinti su nagrinėjamųjų vaistų vieša vertinimo ataskaita ir su ja susijusiais sprendimais, gali kreiptis į:

| 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)  OL L 136, 2004 4 30, p. 1.

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