# Il-Ġurnal Uffiċjali C 150/27 t

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 150 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 6127 ta' April 2018 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 150

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 6127 ta' April 2018

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| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2018/C 150/01 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Marzu 2018 sal-31 ta’ Marzu 2018(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2018/C 150/01

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Marzu 2018 sal-31 ta’ Marzu 2018(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

1

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MT

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IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 27.4.2018 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 150/1 |
| --- | --- | --- | --- |

27.4.2018

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 150/1

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Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Marzu 2018 sal-31 ta’ Marzu 2018

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (1))

(2018/C 150/01)

| — | Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat |
| --- | --- |

—

Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.3.2018 | Shingrix | Vaċċin ta’ herpes zoster (rikombinanti, adjuvantati) | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/18/1272 | Trab u suspensjoni għal suspensjoni għall – injezzjoni | J07BK03 | 23.3.2018 |
| 21.3.2018 | Steglatro | ertugliflozin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1267 | Pillola miksija b’rita | A10BK04 | 23.3.2018 |
| 22.3.2018 | Lokelma | sodium zirconium cyclosilicate | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1173 | Trab għal suspensjoni orali | 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 | Suspensjoni għall-injezzjoni | L04 | 27.3.2018 |
| 23.3.2018 | Lamzede | velmanase alfa | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/17/1258 | Trab għal soluzzjoni għall-infużjoni | A16AB | 27.3.2018 |
| 23.3.2018 | Segluromet | ertugliflozin / metformin hydrochloride | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1265 | Pillola miksija b’rita | A10BD23 | 27.3.2018 |
| 23.3.2018 | Semglee | Insulin glargine | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/18/1270 | Soluzzjoni għall-injezzjoni f’siringa mimlija għal-lest | A10AE04 | 27.3.2018 |
| 23.3.2018 | Steglujan | ertugliflozin / sitagliptin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/18/1266 | Pillola miksija b’rita | A10BD24 | 27.3.2018 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

21.3.2018

Shingrix

Vaċċin ta’ herpes zoster (rikombinanti, adjuvantati)

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/18/1272

Trab u suspensjoni għal suspensjoni għall – injezzjoni

J07BK03

23.3.2018

21.3.2018

Steglatro

ertugliflozin

Merck Sharp & Dohme Limited

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

EU/1/18/1267

Pillola miksija b’rita

A10BK04

23.3.2018

22.3.2018

Lokelma

sodium zirconium cyclosilicate

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1173

Trab għal suspensjoni orali

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

Suspensjoni għall-injezzjoni

L04

27.3.2018

23.3.2018

Lamzede

velmanase alfa

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/17/1258

Trab għal soluzzjoni għall-infużjoni

A16AB

27.3.2018

23.3.2018

Segluromet

ertugliflozin / metformin hydrochloride

Merck Sharp & Dohme Limited

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

EU/1/18/1265

Pillola miksija b’rita

A10BD23

27.3.2018

23.3.2018

Semglee

Insulin glargine

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/18/1270

Soluzzjoni għall-injezzjoni f’siringa mimlija għal-lest

A10AE04

27.3.2018

23.3.2018

Steglujan

ertugliflozin / sitagliptin

Merck Sharp & Dohme Limited

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

EU/1/18/1266

Pillola miksija b’rita

A10BD24

27.3.2018

| — | Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat |
| --- | --- |

—

Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 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 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

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

| — | Irtirar ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) |
| --- | --- |

—

Irtirar ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 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 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

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

| — | Sospensjoni ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 20 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) |
| --- | --- |

—

Sospensjoni ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 20 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 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 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

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

| — | Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat |
| --- | --- |

—

Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 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 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

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

Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

| 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)  ĠU L 136, 30.4.04, p. 1.

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