# Il-Ġurnal Uffiċjali C 118/29 t

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 118 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 6229 ta' Marzu 2019 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 118

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 6229 ta' Marzu 2019

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| Werrej | Paġna |
| --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2019/C 118/01 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Frar 2019 sat-28 ta’ Frar 2019(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |

Werrej

Paġna

IV   Informazzjoni

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

Il-Kummissjoni Ewropea

2019/C 118/01

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Frar 2019 sat-28 ta’ Frar 2019(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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MT

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IV Informazzjoni

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

Il-Kummissjoni Ewropea

| 29.3.2019 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 118/1 |
| --- | --- | --- | --- |

29.3.2019

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 118/1

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Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Frar 2019 sat-28 ta’ Frar 2019

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

(2019/C 118/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.2.2019 | Zirabev | bevacizumab | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/18/1344 | Konċentrat għal soluzzjoni għal infużjoni | L01XC07 | 18.2.2019 |
| 15.2.2019 | Besremi | ropeginterferon alfa-2b | AOP Orphan Pharmaceuticals AG
  Wilhelminenstraβe 91/II f, 1160 Wien, Österreich | EU/1/18/1352 | Soluzzjoni għall-injezzjoni | L03AB15 | 19.2.2019 |
| 18.2.2019 | Lusutrombopag Shionogi | lusutrombopag | Shionogi B.V.
  Kingsfordweg 151, 1043GR Amsterdam, Nederland | EU/1/18/1348 | Pillola miksija b’rita | B02BX07 | 20.2.2019 |
| 18.2.2019 | Miglustat Dipharma | miglustat | Dipharma B.V.
  Prins Bernhardplein 200, 1097 JB Amsterdam, Netherlands | EU/1/18/1346 | Kapsula, iebsa | A16AX06 | 20.2.2019 |
| 18.2.2019 | Rizmoic | naldemedine | Shionogi B.V.
  Kingsfordweg 151, 1043GR Amsterdam, Nederland | EU/1/18/1291 | Pillola miksija b’rita | A06AH05 | 20.2.2019 |
| 18.2.2019 | Tobramycin PARI | Tobramycin | PARI Pharma GmbH
  Moosstraße 3, 82319 Starnberg, Deutschland | EU/1/18/1350 | Soluzzjoni għan-nebulizzatur | J01GB01 | 20.2.2019 |

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

14.2.2019

Zirabev

bevacizumab

Pfizer Europe MA EEIG

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

EU/1/18/1344

Konċentrat għal soluzzjoni għal infużjoni

L01XC07

18.2.2019

15.2.2019

Besremi

ropeginterferon alfa-2b

AOP Orphan Pharmaceuticals AG

Wilhelminenstraβe 91/II f, 1160 Wien, Österreich

EU/1/18/1352

Soluzzjoni għall-injezzjoni

L03AB15

19.2.2019

18.2.2019

Lusutrombopag Shionogi

lusutrombopag

Shionogi B.V.

Kingsfordweg 151, 1043GR Amsterdam, Nederland

EU/1/18/1348

Pillola miksija b’rita

B02BX07

20.2.2019

18.2.2019

Miglustat Dipharma

miglustat

Dipharma B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Netherlands

EU/1/18/1346

Kapsula, iebsa

A16AX06

20.2.2019

18.2.2019

Rizmoic

naldemedine

Shionogi B.V.

Kingsfordweg 151, 1043GR Amsterdam, Nederland

EU/1/18/1291

Pillola miksija b’rita

A06AH05

20.2.2019

18.2.2019

Tobramycin PARI

Tobramycin

PARI Pharma GmbH

Moosstraße 3, 82319 Starnberg, Deutschland

EU/1/18/1350

Soluzzjoni għan-nebulizzatur

J01GB01

20.2.2019

| — | 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 |
| --- | --- | --- | --- | --- |
| 6.2.2019 | Accofil | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/14/946 | 8.2.2019 |
| 6.2.2019 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 8.2.2019 |
| 6.2.2019 | Ammonaps | Swedish Orphan Biovitrum International AB
  112 76 Stockholm, Sverige | EU/1/99/120 | 11.2.2019 |
| 6.2.2019 | Axumin | Blue Earth Diagnostics Ireland Ltd
  6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland | EU/1/17/1186 | 8.2.2019 |
| 6.2.2019 | Epivir | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | EU/1/96/015 | 8.2.2019 |
| 6.2.2019 | Eptifibatide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/15/1065 | 8.2.2019 |
| 6.2.2019 | Ivabradine Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/17/1190 | 8.2.2019 |
| 6.2.2019 | Mirapexin | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/97/051 | 8.2.2019 |
| 6.2.2019 | Mvasi | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/17/1246 | 8.2.2019 |
| 6.2.2019 | Revolade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/612 | 8.2.2019 |
| 6.2.2019 | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363 | 8.2.2019 |
| 6.2.2019 | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | 8.2.2019 |
| 6.2.2019 | Terrosa | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/16/1159 | 8.2.2019 |
| 6.2.2019 | Tolucombi | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | 11.2.2019 |
| 6.2.2019 | Zyprexa Velotab | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/99/125 | 8.2.2019 |
| 7.2.2019 | Circadin | RAD Neurim Pharmaceuticals EEC SARL
  4 rue de Marivaux, 75002 Paris, France | EU/1/07/392 | 15.2.2019 |
| 7.2.2019 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/12/792 | 11.2.2019 |
| 7.2.2019 | Dasselta | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/739 | 11.2.2019 |
| 7.2.2019 | Kisplyx | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/16/1128 | 11.2.2019 |
| 7.2.2019 | Lenvima | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | EU/1/15/1002 | 11.2.2019 |
| 7.2.2019 | Raxone | Santhera Pharmaceuticals (Deutschland) GmbH
  Marie-Curie Straße 8, 79539 Lörrach, Deutschland | EU/1/15/1020 | 11.2.2019 |
| 7.2.2019 | Sifrol | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/97/050 | 11.2.2019 |
| 7.2.2019 | Sycrest | Organon N.V.
  Kloosterstraat 6, 5349 AB Oss, Nederland | EU/1/10/640 | 11.2.2019 |
| 7.2.2019 | Tarceva | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/05/311 | 11.2.2019 |
| 7.2.2019 | Teysuno | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | EU/1/11/669 | 11.2.2019 |
| 8.2.2019 | Helicobacter Test INFAI | INFAI GmbH
  Gottfried-Hagen-Straße 60-62, 51105 Köln, Deutschland | EU/1/97/045 | 12.2.2019 |
| 12.2.2019 | Buccolam | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/709 | 14.2.2019 |
| 12.2.2019 | Caspofungin Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/15/1081 | 15.2.2019 |
| 12.2.2019 | Ebilfumin | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/14/915 | 14.2.2019 |
| 12.2.2019 | Envarsus | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/935 | 14.2.2019 |
| 12.2.2019 | Imraldi | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | EU/1/17/1216 | 14.2.2019 |
| 12.2.2019 | Jinarc | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland | EU/1/15/1000 | 14.2.2019 |
| 12.2.2019 | Liprolog | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/01/195 | 14.2.2019 |
| 12.2.2019 | Yargesa | Piramal Critical Care B.V.
  Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland | EU/1/17/1176 | 14.2.2019 |
| 14.2.2019 | Aripiprazole Mylan Pharma | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1005 | 18.2.2019 |
| 14.2.2019 | Bortezomib Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/16/1114 | 18.2.2019 |
| 14.2.2019 | Fotivda | EUSA Pharma (Netherlands) B.V.
  Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland | EU/1/17/1215 | 18.2.2019 |
| 14.2.2019 | Hemlibra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/18/1271 | 18.2.2019 |
| 14.2.2019 | Imatinib Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/13/845 | 18.2.2019 |
| 14.2.2019 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 18.2.2019 |
| 14.2.2019 | Mekinist | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/931 | 18.2.2019 |
| 14.2.2019 | Modigraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/09/523 | 18.2.2019 |
| 14.2.2019 | Pioglitazone Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/11/722 | 18.2.2019 |
| 14.2.2019 | Quinsair | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/973 | 18.2.2019 |
| 14.2.2019 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 18.2.2019 |
| 14.2.2019 | Sutent | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/06/347 | 18.2.2019 |
| 18.2.2019 | Advagraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/07/387 | 20.2.2019 |
| 18.2.2019 | ATryn | Laboratoire français du Fractionnement et des Biotechnologies
  3 avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France | EU/1/06/355 | 20.2.2019 |
| 18.2.2019 | Bosulif | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | EU/1/13/818 | 20.2.2019 |
| 18.2.2019 | Pixuvri | CTI Life Sciences Deutschland GmbH
  Universitätsstraβe 71, 50931 Köln, Deutschland | EU/1/12/764 | 20.2.2019 |
| 18.2.2019 | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546 | 20.2.2019 |
| 18.2.2019 | Zelboraf | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/12/751 | 20.2.2019 |
| 18.2.2019 | Zyprexa | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/96/022 | 20.2.2019 |
| 20.2.2019 | Bortezomib Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/15/1019 | 22.2.2019 |
| 20.2.2019 | Bortezomib SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/16/1102 | 22.2.2019 |
| 20.2.2019 | Entyvio | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/923 | 22.2.2019 |
| 20.2.2019 | Eurartesim | Alfasigma S.p.A.
  Via Ragazzi del ‘99, n.5, 40133 Bologna, Italia | EU/1/11/716 | 22.2.2019 |
| 20.2.2019 | Ibandronic acid Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/12/798 | 22.2.2019 |
| 20.2.2019 | Mepact | Takeda France SAS
  Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France | EU/1/08/502 | 22.2.2019 |
| 20.2.2019 | Renvela | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/09/521 | 26.2.2019 |
| 20.2.2019 | Simbrinza | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/933 | 22.2.2019 |
| 20.2.2019 | Sustiva | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/99/110 | 22.2.2019 |
| 20.2.2019 | Vabomere | Menarini International Operations Lussemburgu S.A.
  1 avenue de la Gare, 1611 Lussemburgu, Grand-Duché de Lussemburgu | EU/1/18/1334 | 25.2.2019 |
| 20.2.2019 | VELCADE | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/04/274 | 22.2.2019 |
| 20.2.2019 | Voriconazole Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/13/835 | 22.2.2019 |
| 20.2.2019 | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/11/714 | 22.2.2019 |
| 25.2.2019 | AFSTYLA | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | EU/1/16/1158 | 27.2.2019 |
| 25.2.2019 | Amlodipine/Valsartan Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/16/1092 | 27.2.2019 |
| 25.2.2019 | Bortezomib Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/15/1019 | 27.2.2019 |
| 25.2.2019 | Capecitabine Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/12/762 | 27.2.2019 |
| 25.2.2019 | Entecavir Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/17/1211 | 27.2.2019 |
| 25.2.2019 | Fasenra | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/17/1252 | 27.2.2019 |
| 25.2.2019 | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/16/1160 | 27.2.2019 |
| 25.2.2019 | Hetlioz | Vanda Pharmaceuticals Germany GmbH
  Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland | EU/1/15/1008 | 27.2.2019 |
| 25.2.2019 | Miglustat Gen.Orph | Gen.Orph
  185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France | EU/1/17/1232 | 27.2.2019 |
| 25.2.2019 | Pemetrexed Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/15/1071 | 27.3.2019 |
| 25.2.2019 | Repaglinide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/11/743 | 27.2.2019 |
| 25.2.2019 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 27.2.2019 |
| 25.2.2019 | Temozolomide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | EU/1/10/615 | 27.2.2019 |
| 25.2.2019 | Zavicefta | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | EU/1/16/1109 | 27.2.2019 |
| 25.2.2019 | Zyclara | Meda AB
  Pipers väg 2 A, 170 73 Solna, Sverige | EU/1/12/783 | 27.2.2019 |
| 25.2.2019 | Zypadhera | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/08/479 | 27.2.2019 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

6.2.2019

Accofil

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/14/946

8.2.2019

6.2.2019

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

8.2.2019

6.2.2019

Ammonaps

Swedish Orphan Biovitrum International AB

112 76 Stockholm, Sverige

EU/1/99/120

11.2.2019

6.2.2019

Axumin

Blue Earth Diagnostics Ireland Ltd

6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland

EU/1/17/1186

8.2.2019

6.2.2019

Epivir

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

EU/1/96/015

8.2.2019

6.2.2019

Eptifibatide Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/15/1065

8.2.2019

6.2.2019

Ivabradine Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/17/1190

8.2.2019

6.2.2019

Mirapexin

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/051

8.2.2019

6.2.2019

Mvasi

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/17/1246

8.2.2019

6.2.2019

Revolade

Novartis Europharm Limited

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

EU/1/10/612

8.2.2019

6.2.2019

Sprycel

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/363

8.2.2019

6.2.2019

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

8.2.2019

6.2.2019

Terrosa

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/16/1159

8.2.2019

6.2.2019

Tolucombi

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/821

11.2.2019

6.2.2019

Zyprexa Velotab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/99/125

8.2.2019

7.2.2019

Circadin

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

EU/1/07/392

15.2.2019

7.2.2019

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/12/792

11.2.2019

7.2.2019

Dasselta

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/739

11.2.2019

7.2.2019

Kisplyx

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/16/1128

11.2.2019

7.2.2019

Lenvima

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

EU/1/15/1002

11.2.2019

7.2.2019

Raxone

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Straße 8, 79539 Lörrach, Deutschland

EU/1/15/1020

11.2.2019

7.2.2019

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/97/050

11.2.2019

7.2.2019

Sycrest

Organon N.V.

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/10/640

11.2.2019

7.2.2019

Tarceva

Roche Registration GmbH

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

EU/1/05/311

11.2.2019

7.2.2019

Teysuno

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

EU/1/11/669

11.2.2019

8.2.2019

Helicobacter Test INFAI

INFAI GmbH

Gottfried-Hagen-Straße 60-62, 51105 Köln, Deutschland

EU/1/97/045

12.2.2019

12.2.2019

Buccolam

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/709

14.2.2019

12.2.2019

Caspofungin Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/15/1081

15.2.2019

12.2.2019

Ebilfumin

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/14/915

14.2.2019

12.2.2019

Envarsus

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/935

14.2.2019

12.2.2019

Imraldi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

EU/1/17/1216

14.2.2019

12.2.2019

Jinarc

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland

EU/1/15/1000

14.2.2019

12.2.2019

Liprolog

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/01/195

14.2.2019

12.2.2019

Yargesa

Piramal Critical Care B.V.

Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland

EU/1/17/1176

14.2.2019

14.2.2019

Aripiprazole Mylan Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1005

18.2.2019

14.2.2019

Bortezomib Hospira

Pfizer Europe MA EEIG

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

EU/1/16/1114

18.2.2019

14.2.2019

Fotivda

EUSA Pharma (Netherlands) B.V.

Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland

EU/1/17/1215

18.2.2019

14.2.2019

Hemlibra

Roche Registration GmbH

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

EU/1/18/1271

18.2.2019

14.2.2019

Imatinib Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/13/845

18.2.2019

14.2.2019

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

18.2.2019

14.2.2019

Mekinist

Novartis Europharm Limited

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

EU/1/14/931

18.2.2019

14.2.2019

Modigraf

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/09/523

18.2.2019

14.2.2019

Pioglitazone Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/11/722

18.2.2019

14.2.2019

Quinsair

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/973

18.2.2019

14.2.2019

Silgard

Merck Sharp & Dohme Limited

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

EU/1/06/358

18.2.2019

14.2.2019

Sutent

Pfizer Europe MA EEIG

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

EU/1/06/347

18.2.2019

18.2.2019

Advagraf

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/07/387

20.2.2019

18.2.2019

ATryn

Laboratoire français du Fractionnement et des Biotechnologies

3 avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France

EU/1/06/355

20.2.2019

18.2.2019

Bosulif

Pfizer Europe MA EEIG

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

EU/1/13/818

20.2.2019

18.2.2019

Pixuvri

CTI Life Sciences Deutschland GmbH

Universitätsstraβe 71, 50931 Köln, Deutschland

EU/1/12/764

20.2.2019

18.2.2019

Simponi

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546

20.2.2019

18.2.2019

Zelboraf

Roche Registration GmbH

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

EU/1/12/751

20.2.2019

18.2.2019

Zyprexa

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/022

20.2.2019

20.2.2019

Bortezomib Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/15/1019

22.2.2019

20.2.2019

Bortezomib SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/16/1102

22.2.2019

20.2.2019

Entyvio

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/923

22.2.2019

20.2.2019

Eurartesim

Alfasigma S.p.A.

Via Ragazzi del ‘99, n.5, 40133 Bologna, Italia

EU/1/11/716

22.2.2019

20.2.2019

Ibandronic acid Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/12/798

22.2.2019

20.2.2019

Mepact

Takeda France SAS

Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France

EU/1/08/502

22.2.2019

20.2.2019

Renvela

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/09/521

26.2.2019

20.2.2019

Simbrinza

Novartis Europharm Limited

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

EU/1/14/933

22.2.2019

20.2.2019

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110

22.2.2019

20.2.2019

Vabomere

Menarini International Operations Lussemburgu S.A.

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

EU/1/18/1334

25.2.2019

20.2.2019

VELCADE

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/04/274

22.2.2019

20.2.2019

Voriconazole Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/13/835

22.2.2019

20.2.2019

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/11/714

22.2.2019

25.2.2019

AFSTYLA

CSL Behring GmbH

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

EU/1/16/1158

27.2.2019

25.2.2019

Amlodipine/Valsartan Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/16/1092

27.2.2019

25.2.2019

Bortezomib Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/15/1019

27.2.2019

25.2.2019

Capecitabine Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/12/762

27.2.2019

25.2.2019

Entecavir Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/17/1211

27.2.2019

25.2.2019

Fasenra

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/17/1252

27.2.2019

25.2.2019

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/16/1160

27.2.2019

25.2.2019

Hetlioz

Vanda Pharmaceuticals Germany GmbH

Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland

EU/1/15/1008

27.2.2019

25.2.2019

Miglustat Gen.Orph

Gen.Orph

185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France

EU/1/17/1232

27.2.2019

25.2.2019

Pemetrexed Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/15/1071

27.3.2019

25.2.2019

Repaglinide Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/11/743

27.2.2019

25.2.2019

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

27.2.2019

25.2.2019

Temozolomide Accord

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España

EU/1/10/615

27.2.2019

25.2.2019

Zavicefta

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

EU/1/16/1109

27.2.2019

25.2.2019

Zyclara

Meda AB

Pipers väg 2 A, 170 73 Solna, Sverige

EU/1/12/783

27.2.2019

25.2.2019

Zypadhera

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/08/479

27.2.2019

| — | 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 |
| --- | --- | --- | --- | --- |
| 14.2.2019 | Imatinib Medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | EU/1/13/876 | 18.2.2019 |
| 18.2.2019 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 20.2.2019 |
| 18.2.2019 | Vantobra | PARI Pharma GmbH
  Moosstraße 3, 82319 Starnberg, Deutschland | EU/1/14/932 | 20.2.2019 |
| 20.2.2019 | ATryn | Laboratoire français du Fractionnement et des Biotechnologies
  3 avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France | EU/1/06/355 | 22.2.2019 |
| 25.2.2019 | Altargo | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/390 | 27.2.2019 |
| 25.2.2019 | Arzerra | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/625 | 27.2.2019 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

14.2.2019

Imatinib Medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

EU/1/13/876

18.2.2019

18.2.2019

Silgard

Merck Sharp & Dohme Limited

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

EU/1/06/358

20.2.2019

18.2.2019

Vantobra

PARI Pharma GmbH

Moosstraße 3, 82319 Starnberg, Deutschland

EU/1/14/932

20.2.2019

20.2.2019

ATryn

Laboratoire français du Fractionnement et des Biotechnologies

3 avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France

EU/1/06/355

22.2.2019

25.2.2019

Altargo

Glaxo Group Ltd

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

EU/1/07/390

27.2.2019

25.2.2019

Arzerra

Novartis Europharm Limited

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

EU/1/10/625

27.2.2019

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

—

Ħruġ 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 | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.2.2019 | EVANT | Il-vaċċin tal-coccidiosis ħaj għat-tiġieġ | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/18/233 | Suspensjoni u solvent għal sprej mill-ħalq | QI01AN01 | 7.2.2019 |
| 8.2.2019 | Kriptazen | halofuginone | Virbac
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | EU/2/18/234 | Soluzzjoni orali | QP51AX08 | 12.2.2019 |

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

5.2.2019

EVANT

Il-vaċċin tal-coccidiosis ħaj għat-tiġieġ

Laboratorios Hipra, S.A.

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

EU/2/18/233

Suspensjoni u solvent għal sprej mill-ħalq

QI01AN01

7.2.2019

8.2.2019

Kriptazen

halofuginone

Virbac

1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France

EU/2/18/234

Soluzzjoni orali

QP51AX08

12.2.2019

| — | 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 |
| --- | --- | --- | --- | --- |
| 4.2.2019 | CYTOPOINT | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/205 | 6.2.2019 |
| 4.2.2019 | Zycortal | Dechra Regulatory B.V.
  Handelsweg 25, 5531 AE Bladel, Nederland | EU/2/15/189 | 6.2.2019 |
| 5.2.2019 | Bravecto | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/13/158 | 7.2.2019 |
| 5.2.2019 | Equisolon | Le Vet B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | EU/2/14/161 | 7.2.2019 |
| 8.2.2019 | Halagon | Emdoka bvba
  J. Lijsenstraat 16, 2321 Hoogstraten, België | EU/2/16/201 | 12.2.2019 |
| 8.2.2019 | STARTVAC | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/08/092 | 12.2.2019 |
| 8.2.2019 | Vaxxitek HVT + IBD | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | EU/2/02/032 | 12.2.2019 |
| 8.2.2019 | Vectra Felis | Ceva Santé Animale
  10 avenue de la Ballastière, 33500 Libourne, France | EU/2/14/165 | 12.2.2019 |
| 21.2.2019 | BLUEVAC BTV8 | CZ Veterinaria, S.A.
  La Relva s/n, P.O. Box 16, 36400 Porriño, España | EU/2/11/122 | 25.2.2019 |
| 21.2.2019 | Zulvac BTV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/17/207 | 25.2.2019 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

4.2.2019

CYTOPOINT

Zoetis Belgium S.A.

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

EU/2/17/205

6.2.2019

4.2.2019

Zycortal

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

EU/2/15/189

6.2.2019

5.2.2019

Bravecto

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/13/158

7.2.2019

5.2.2019

Equisolon

Le Vet B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/14/161

7.2.2019

8.2.2019

Halagon

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

EU/2/16/201

12.2.2019

8.2.2019

STARTVAC

Laboratorios Hipra, S.A.

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

EU/2/08/092

12.2.2019

8.2.2019

Vaxxitek HVT + IBD

Merial

29 avenue Tony Garnier, 69007 Lyon, France

EU/2/02/032

12.2.2019

8.2.2019

Vectra Felis

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/14/165

12.2.2019

21.2.2019

BLUEVAC BTV8

CZ Veterinaria, S.A.

La Relva s/n, P.O. Box 16, 36400 Porriño, España

EU/2/11/122

25.2.2019

21.2.2019

Zulvac BTV

Zoetis Belgium S.A.

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

EU/2/17/207

25.2.2019

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, 30.4.2004, p. 1.

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