# Europos Sąjungos C 118/2019

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 118 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 62 metai2019m. kovo 29d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 118

Leidimas lietuvių kalba

Informacija ir pranešimai

62 metai2019m. kovo 29d.

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| Turinys | Puslapis |
| --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2019/C 118/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2019 m. vasario 1 d. iki 2019 m. vasario 28 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį) | 1 |

Turinys

Puslapis

IV   Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

2019/C 118/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2019 m. vasario 1 d. iki 2019 m. vasario 28 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

| 29.3.2019 | LT | Europos Sąjungos oficialusis leidinys | C 118/1 |
| --- | --- | --- | --- |

29.3.2019

LT

Europos Sąjungos oficialusis leidinys

C 118/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2019 m. vasario 1 d. iki 2019 m. vasario 28 d.

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

(2019/C 118/01)

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2019 2 14 | Zirabev | bevacizumabas | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/18/1344 | Koncentratas infuziniam tirpalui | L01XC07 | 2019 2 18 |
| 2019 2 15 | Besremi | alfa-2b ropeginterferonas | AOP Orphan Pharmaceuticals AG
  Wilhelminenstraβe 91/II f, 1160 Wien, Österreich | ES/1/18/1352 | Injekcinis tirpalas | L03AB15 | 2019 2 19 |
| 2019 2 18 | Lusutrombopag Shionogi | luzutrombopagas | Shionogi B.V.
  Kingsfordweg 151, 1043GR Amsterdam, Nederland | ES/1/18/1348 | Plėvele dengta tabletė | B02BX07 | 2019 2 20 |
| 2019 2 18 | Miglustat Dipharma | miglustatas | Dipharma B.V.
  Prins Bernhardplein 200, 1097 JB Amsterdam, Netherlands | ES/1/18/1346 | Kieta kapsulė | A16AX06 | 2019 2 20 |
| 2019 2 18 | Rizmoic | naldemedinas | Shionogi B.V.
  Kingsfordweg 151, 1043GR Amsterdam, Nederland | ES/1/18/1291 | Plėvele dengta tabletė | A06AH05 | 2019 2 20 |
| 2019 2 18 | Tobramycin PARI | Tobramicinas | PARI Pharma GmbH
  Moosstraße 3, 82319 Starnberg, Deutschland | ES/1/18/1350 | Purškiamasis tirpalas | J01GB01 | 2019 2 20 |

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

2019 2 14

Zirabev

bevacizumabas

Pfizer Europe MA EEIG

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

ES/1/18/1344

Koncentratas infuziniam tirpalui

L01XC07

2019 2 18

2019 2 15

Besremi

alfa-2b ropeginterferonas

AOP Orphan Pharmaceuticals AG

Wilhelminenstraβe 91/II f, 1160 Wien, Österreich

ES/1/18/1352

Injekcinis tirpalas

L03AB15

2019 2 19

2019 2 18

Lusutrombopag Shionogi

luzutrombopagas

Shionogi B.V.

Kingsfordweg 151, 1043GR Amsterdam, Nederland

ES/1/18/1348

Plėvele dengta tabletė

B02BX07

2019 2 20

2019 2 18

Miglustat Dipharma

miglustatas

Dipharma B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Netherlands

ES/1/18/1346

Kieta kapsulė

A16AX06

2019 2 20

2019 2 18

Rizmoic

naldemedinas

Shionogi B.V.

Kingsfordweg 151, 1043GR Amsterdam, Nederland

ES/1/18/1291

Plėvele dengta tabletė

A06AH05

2019 2 20

2019 2 18

Tobramycin PARI

Tobramicinas

PARI Pharma GmbH

Moosstraße 3, 82319 Starnberg, Deutschland

ES/1/18/1350

Purškiamasis tirpalas

J01GB01

2019 2 20

| — | 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 |
| --- | --- | --- | --- | --- |
| 2019 2 6 | Accofil | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/14/946 | 2019 2 8 |
| 2019 2 6 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | ES/1/12/794 | 2019 2 8 |
| 2019 2 6 | Ammonaps | Swedish Orphan Biovitrum International AB
  112 76 Stockholm, Sverige | ES/1/99/120 | 2019 2 11 |
| 2019 2 6 | Axumin | Blue Earth Diagnostics Ireland Ltd
  6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland | ES/1/17/1186 | 2019 2 8 |
| 2019 2 6 | Epivir | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | ES/1/96/015 | 2019 2 8 |
| 2019 2 6 | Eptifibatide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/15/1065 | 2019 2 8 |
| 2019 2 6 | Ivabradine Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/17/1190 | 2019 2 8 |
| 2019 2 6 | Mirapexin | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/97/051 | 2019 2 8 |
| 2019 2 6 | Mvasi | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | ES/1/17/1246 | 2019 2 8 |
| 2019 2 6 | Revolade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/10/612 | 2019 2 8 |
| 2019 2 6 | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | ES/1/06/363 | 2019 2 8 |
| 2019 2 6 | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/15/1085 | 2019 2 8 |
| 2019 2 6 | Terrosa | Gedeon Richter Plc.
  Gyömrői út 19–21., 1103 Budapest, Magyarország | ES/1/16/1159 | 2019 2 8 |
| 2019 2 6 | Tolucombi | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | ES/1/13/821 | 2019 2 11 |
| 2019 2 6 | Zyprexa Velotab | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/99/125 | 2019 2 8 |
| 2019 2 7 | Circadin | RAD Neurim Pharmaceuticals EEC SARL
  4 rue de Marivaux, 75002 Paris, France | ES/1/07/392 | 2019 2 15 |
| 2019 2 7 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/12/792 | 2019 2 11 |
| 2019 2 7 | Dasselta | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | ES/1/11/739 | 2019 2 11 |
| 2019 2 7 | Kisplyx | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | ES/1/16/1128 | 2019 2 11 |
| 2019 2 7 | Lenvima | Eisai GmbH
  Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland | ES/1/15/1002 | 2019 2 11 |
| 2019 2 7 | Raxone | Santhera Pharmaceuticals (Deutschland) GmbH
  Marie-Curie Straße 8, 79539 Lörrach, Deutschland | ES/1/15/1020 | 2019 2 11 |
| 2019 2 7 | Sifrol | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/97/050 | 2019 2 11 |
| 2019 2 7 | Sycrest | Organon N.V.
  Kloosterstraat 6, 5349 AB Oss, Nederland | ES/1/10/640 | 2019 2 11 |
| 2019 2 7 | Tarceva | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | ES/1/05/311 | 2019 2 11 |
| 2019 2 7 | Teysuno | Nordic Group B.V.
  Siriusdreef 22, 2132 WT Hoofddorp, Nederland | ES/1/11/669 | 2019 2 11 |
| 2019 2 8 | Helicobacter Test INFAI | INFAI GmbH
  Gottfried-Hagen-Straße 60–62, 51105 Köln, Deutschland | ES/1/97/045 | 2019 2 12 |
| 2019 2 12 | Buccolam | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | ES/1/11/709 | 2019 2 14 |
| 2019 2 12 | Caspofungin Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/15/1081 | 2019 2 15 |
| 2019 2 12 | Ebilfumin | Actavis Group PTC ehf.
  Reykjavíkurvegi 76–78, 220 Hafnarfjörður, Íceland | ES/1/14/915 | 2019 2 14 |
| 2019 2 12 | Envarsus | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | ES/1/14/935 | 2019 2 14 |
| 2019 2 12 | Imraldi | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | ES/1/17/1216 | 2019 2 14 |
| 2019 2 12 | Jinarc | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland | ES/1/15/1000 | 2019 2 14 |
| 2019 2 12 | Liprolog | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/01/195 | 2019 2 14 |
| 2019 2 12 | Yargesa | Piramal Critical Care B.V.
  Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland | ES/1/17/1176 | 2019 2 14 |
| 2019 2 14 | Aripiprazole Mylan Pharma | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/15/1005 | 2019 2 18 |
| 2019 2 14 | Bortezomib Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/16/1114 | 2019 2 18 |
| 2019 2 14 | Fotivda | EUSA Pharma (Netherlands) B.V.
  Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland | ES/1/17/1215 | 2019 2 18 |
| 2019 2 14 | Hemlibra | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | ES/1/18/1271 | 2019 2 18 |
| 2019 2 14 | Imatinib Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/13/845 | 2019 2 18 |
| 2019 2 14 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/14/930 | 2019 2 18 |
| 2019 2 14 | Mekinist | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/14/931 | 2019 2 18 |
| 2019 2 14 | Modigraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | ES/1/09/523 | 2019 2 18 |
| 2019 2 14 | Pioglitazone Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/11/722 | 2019 2 18 |
| 2019 2 14 | Quinsair | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | ES/1/14/973 | 2019 2 18 |
| 2019 2 14 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/06/358 | 2019 2 18 |
| 2019 2 14 | Sutent | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/06/347 | 2019 2 18 |
| 2019 2 18 | Advagraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | ES/1/07/387 | 2019 2 20 |
| 2019 2 18 | ATryn | Laboratoire français du Fractionnement et des Biotechnologies
  3 avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France | ES/1/06/355 | 2019 2 20 |
| 2019 2 18 | Bosulif | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/13/818 | 2019 2 20 |
| 2019 2 18 | Pixuvri | CTI Life Sciences Deutschland GmbH
  Universitätsstraβe 71, 50931 Köln, Deutschland | ES/1/12/764 | 2019 2 20 |
| 2019 2 18 | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | ES/1/09/546 | 2019 2 20 |
| 2019 2 18 | Zelboraf | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | ES/1/12/751 | 2019 2 20 |
| 2019 2 18 | Zyprexa | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/96/022 | 2019 2 20 |
| 2019 2 20 | Bortezomib Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/15/1019 | 2019 2 22 |
| 2019 2 20 | Bortezomib SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | ES/1/16/1102 | 2019 2 22 |
| 2019 2 20 | Entyvio | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | ES/1/14/923 | 2019 2 22 |
| 2019 2 20 | Eurartesim | Alfasigma S.p.A.
  Via Ragazzi del ’99, n.5, 40133 Bologna, Italia | ES/1/11/716 | 2019 2 22 |
| 2019 2 20 | Ibandronic acid Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/12/798 | 2019 2 22 |
| 2019 2 20 | Mepact | Takeda France SAS
  Immeuble Pacific, 11–13 cours Valmy, 92800 Puteaux, France | ES/1/08/502 | 2019 2 22 |
| 2019 2 20 | Renvela | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | ES/1/09/521 | 2019 2 26 |
| 2019 2 20 | Simbrinza | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/14/933 | 2019 2 22 |
| 2019 2 20 | Sustiva | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | ES/1/99/110 | 2019 2 22 |
| 2019 2 20 | Vabomere | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | ES/1/18/1334 | 2019 2 25 |
| 2019 2 20 | VELCADE | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/04/274 | 2019 2 22 |
| 2019 2 20 | Voriconazole Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/13/835 | 2019 2 22 |
| 2019 2 20 | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/11/714 | 2019 2 22 |
| 2019 2 25 | AFSTYLA | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | ES/1/16/1158 | 2019 2 27 |
| 2019 2 25 | Amlodipine/Valsartan Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/16/1092 | 2019 2 27 |
| 2019 2 25 | Bortezomib Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/15/1019 | 2019 2 27 |
| 2019 2 25 | Capecitabine Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/12/762 | 2019 2 27 |
| 2019 2 25 | Entecavir Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/17/1211 | 2019 2 27 |
| 2019 2 25 | Fasenra | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/17/1252 | 2019 2 27 |
| 2019 2 25 | Fiasp | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | ES/1/16/1160 | 2019 2 27 |
| 2019 2 25 | Hetlioz | Vanda Pharmaceuticals Germany GmbH
  Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland | ES/1/15/1008 | 2019 2 27 |
| 2019 2 25 | Miglustat Gen.Orph | Gen.Orph
  185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France | ES/1/17/1232 | 2019 2 27 |
| 2019 2 25 | Pemetrexed Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/15/1071 | 2019 3 27 |
| 2019 2 25 | Repaglinide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/11/743 | 2019 2 27 |
| 2019 2 25 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | ES/1/17/1220 | 2019 2 27 |
| 2019 2 25 | Temozolomide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/10/615 | 2019 2 27 |
| 2019 2 25 | Zavicefta | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | ES/1/16/1109 | 2019 2 27 |
| 2019 2 25 | Zyclara | MEDA AB
  Pipers väg 2A, 170 73 Solna, Sverige | ES/1/12/783 | 2019 2 27 |
| 2019 2 25 | Zypadhera | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/08/479 | 2019 2 27 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2019 2 6

Accofil

Accord Healthcare S.L.U.

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

ES/1/14/946

2019 2 8

2019 2 6

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

ES/1/12/794

2019 2 8

2019 2 6

Ammonaps

Swedish Orphan Biovitrum International AB

112 76 Stockholm, Sverige

ES/1/99/120

2019 2 11

2019 2 6

Axumin

Blue Earth Diagnostics Ireland Ltd

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

ES/1/17/1186

2019 2 8

2019 2 6

Epivir

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

ES/1/96/015

2019 2 8

2019 2 6

Eptifibatide Accord

Accord Healthcare S.L.U.

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

ES/1/15/1065

2019 2 8

2019 2 6

Ivabradine Accord

Accord Healthcare S.L.U.

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

ES/1/17/1190

2019 2 8

2019 2 6

Mirapexin

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/97/051

2019 2 8

2019 2 6

Mvasi

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

ES/1/17/1246

2019 2 8

2019 2 6

Revolade

Novartis Europharm Limited

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

ES/1/10/612

2019 2 8

2019 2 6

Sprycel

Bristol-Myers Squibb Pharma EEIG

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

ES/1/06/363

2019 2 8

2019 2 6

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/15/1085

2019 2 8

2019 2 6

Terrosa

Gedeon Richter Plc.

Gyömrői út 19–21., 1103 Budapest, Magyarország

ES/1/16/1159

2019 2 8

2019 2 6

Tolucombi

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

ES/1/13/821

2019 2 11

2019 2 6

Zyprexa Velotab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/99/125

2019 2 8

2019 2 7

Circadin

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

ES/1/07/392

2019 2 15

2019 2 7

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/12/792

2019 2 11

2019 2 7

Dasselta

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

ES/1/11/739

2019 2 11

2019 2 7

Kisplyx

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

ES/1/16/1128

2019 2 11

2019 2 7

Lenvima

Eisai GmbH

Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland

ES/1/15/1002

2019 2 11

2019 2 7

Raxone

Santhera Pharmaceuticals (Deutschland) GmbH

Marie-Curie Straße 8, 79539 Lörrach, Deutschland

ES/1/15/1020

2019 2 11

2019 2 7

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/97/050

2019 2 11

2019 2 7

Sycrest

Organon N.V.

Kloosterstraat 6, 5349 AB Oss, Nederland

ES/1/10/640

2019 2 11

2019 2 7

Tarceva

Roche Registration GmbH

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

ES/1/05/311

2019 2 11

2019 2 7

Teysuno

Nordic Group B.V.

Siriusdreef 22, 2132 WT Hoofddorp, Nederland

ES/1/11/669

2019 2 11

2019 2 8

Helicobacter Test INFAI

INFAI GmbH

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

ES/1/97/045

2019 2 12

2019 2 12

Buccolam

Shire Services BVBA

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

ES/1/11/709

2019 2 14

2019 2 12

Caspofungin Accord

Accord Healthcare S.L.U.

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

ES/1/15/1081

2019 2 15

2019 2 12

Ebilfumin

Actavis Group PTC ehf.

Reykjavíkurvegi 76–78, 220 Hafnarfjörður, Íceland

ES/1/14/915

2019 2 14

2019 2 12

Envarsus

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

ES/1/14/935

2019 2 14

2019 2 12

Imraldi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

ES/1/17/1216

2019 2 14

2019 2 12

Jinarc

Otsuka Pharmaceutical Netherlands B.V.

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

ES/1/15/1000

2019 2 14

2019 2 12

Liprolog

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/01/195

2019 2 14

2019 2 12

Yargesa

Piramal Critical Care B.V.

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

ES/1/17/1176

2019 2 14

2019 2 14

Aripiprazole Mylan Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/15/1005

2019 2 18

2019 2 14

Bortezomib Hospira

Pfizer Europe MA EEIG

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

ES/1/16/1114

2019 2 18

2019 2 14

Fotivda

EUSA Pharma (Netherlands) B.V.

Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland

ES/1/17/1215

2019 2 18

2019 2 14

Hemlibra

Roche Registration GmbH

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

ES/1/18/1271

2019 2 18

2019 2 14

Imatinib Accord

Accord Healthcare S.L.U.

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

ES/1/13/845

2019 2 18

2019 2 14

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/14/930

2019 2 18

2019 2 14

Mekinist

Novartis Europharm Limited

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

ES/1/14/931

2019 2 18

2019 2 14

Modigraf

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

ES/1/09/523

2019 2 18

2019 2 14

Pioglitazone Accord

Accord Healthcare S.L.U.

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

ES/1/11/722

2019 2 18

2019 2 14

Quinsair

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

ES/1/14/973

2019 2 18

2019 2 14

Silgard

Merck Sharp & Dohme Limited

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

ES/1/06/358

2019 2 18

2019 2 14

Sutent

Pfizer Europe MA EEIG

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

ES/1/06/347

2019 2 18

2019 2 18

Advagraf

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

ES/1/07/387

2019 2 20

2019 2 18

ATryn

Laboratoire français du Fractionnement et des Biotechnologies

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

ES/1/06/355

2019 2 20

2019 2 18

Bosulif

Pfizer Europe MA EEIG

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

ES/1/13/818

2019 2 20

2019 2 18

Pixuvri

CTI Life Sciences Deutschland GmbH

Universitätsstraβe 71, 50931 Köln, Deutschland

ES/1/12/764

2019 2 20

2019 2 18

Simponi

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

ES/1/09/546

2019 2 20

2019 2 18

Zelboraf

Roche Registration GmbH

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

ES/1/12/751

2019 2 20

2019 2 18

Zyprexa

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/96/022

2019 2 20

2019 2 20

Bortezomib Accord

Accord Healthcare S.L.U.

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

ES/1/15/1019

2019 2 22

2019 2 20

Bortezomib SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

ES/1/16/1102

2019 2 22

2019 2 20

Entyvio

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

ES/1/14/923

2019 2 22

2019 2 20

Eurartesim

Alfasigma S.p.A.

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

ES/1/11/716

2019 2 22

2019 2 20

Ibandronic acid Accord

Accord Healthcare S.L.U.

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

ES/1/12/798

2019 2 22

2019 2 20

Mepact

Takeda France SAS

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

ES/1/08/502

2019 2 22

2019 2 20

Renvela

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

ES/1/09/521

2019 2 26

2019 2 20

Simbrinza

Novartis Europharm Limited

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

ES/1/14/933

2019 2 22

2019 2 20

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

ES/1/99/110

2019 2 22

2019 2 20

Vabomere

Menarini International Operations Luxembourg S.A.

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

ES/1/18/1334

2019 2 25

2019 2 20

VELCADE

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/04/274

2019 2 22

2019 2 20

Voriconazole Accord

Accord Healthcare S.L.U.

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

ES/1/13/835

2019 2 22

2019 2 20

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/11/714

2019 2 22

2019 2 25

AFSTYLA

CSL Behring GmbH

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

ES/1/16/1158

2019 2 27

2019 2 25

Amlodipine/Valsartan Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/16/1092

2019 2 27

2019 2 25

Bortezomib Accord

Accord Healthcare S.L.U.

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

ES/1/15/1019

2019 2 27

2019 2 25

Capecitabine Accord

Accord Healthcare S.L.U.

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

ES/1/12/762

2019 2 27

2019 2 25

Entecavir Accord

Accord Healthcare S.L.U.

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

ES/1/17/1211

2019 2 27

2019 2 25

Fasenra

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/17/1252

2019 2 27

2019 2 25

Fiasp

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

ES/1/16/1160

2019 2 27

2019 2 25

Hetlioz

Vanda Pharmaceuticals Germany GmbH

Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland

ES/1/15/1008

2019 2 27

2019 2 25

Miglustat Gen.Orph

Gen.Orph

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

ES/1/17/1232

2019 2 27

2019 2 25

Pemetrexed Accord

Accord Healthcare S.L.U.

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

ES/1/15/1071

2019 3 27

2019 2 25

Repaglinide Accord

Accord Healthcare S.L.U.

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

ES/1/11/743

2019 2 27

2019 2 25

Tecentriq

Roche Registration GmbH

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

ES/1/17/1220

2019 2 27

2019 2 25

Temozolomide Accord

Accord Healthcare S.L.U.

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

ES/1/10/615

2019 2 27

2019 2 25

Zavicefta

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

ES/1/16/1109

2019 2 27

2019 2 25

Zyclara

MEDA AB

Pipers väg 2A, 170 73 Solna, Sverige

ES/1/12/783

2019 2 27

2019 2 25

Zypadhera

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/08/479

2019 2 27

| — | 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 |
| --- | --- | --- | --- | --- |
| 2019 2 14 | Imatinib Medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstraße 6, 22880 Wedel, Deutschland | ES/1/13/876 | 2019 2 18 |
| 2019 2 18 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | ES/1/06/358 | 2019 2 20 |
| 2019 2 18 | Vantobra | PARI Pharma GmbH
  Moosstraße 3, 82319 Starnberg, Deutschland | ES/1/14/932 | 2019 2 20 |
| 2019 2 20 | ATryn | Laboratoire français du Fractionnement et des Biotechnologies
  3 avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France | ES/1/06/355 | 2019 2 22 |
| 2019 2 25 | Altargo | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ES/1/07/390 | 2019 2 27 |
| 2019 2 25 | Arzerra | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/10/625 | 2019 2 27 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2019 2 14

Imatinib Medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstraße 6, 22880 Wedel, Deutschland

ES/1/13/876

2019 2 18

2019 2 18

Silgard

Merck Sharp & Dohme Limited

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

ES/1/06/358

2019 2 20

2019 2 18

Vantobra

PARI Pharma GmbH

Moosstraße 3, 82319 Starnberg, Deutschland

ES/1/14/932

2019 2 20

2019 2 20

ATryn

Laboratoire français du Fractionnement et des Biotechnologies

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

ES/1/06/355

2019 2 22

2019 2 25

Altargo

Glaxo Group Ltd

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

ES/1/07/390

2019 2 27

2019 2 25

Arzerra

Novartis Europharm Limited

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

ES/1/10/625

2019 2 27

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

—

Rinkodaros leidimo suteikimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2019 2 5 | EVANT | Vakcina nuo paukščių kokcidiozės (gyva) | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | ES/2/18/233 | Suspensija ir tirpiklis burnos purškalui | QI01AN01 | 2019 2 7 |
| 2019 2 8 | Kriptazen | halofuginonas | Virbac
  1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France | ES/2/18/234 | Geriamasis tirpalas | QP51AX08 | 2019 2 12 |

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

2019 2 5

EVANT

Vakcina nuo paukščių kokcidiozės (gyva)

Laboratorios Hipra, S.A.

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

ES/2/18/233

Suspensija ir tirpiklis burnos purškalui

QI01AN01

2019 2 7

2019 2 8

Kriptazen

halofuginonas

Virbac

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

ES/2/18/234

Geriamasis tirpalas

QP51AX08

2019 2 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 |
| --- | --- | --- | --- | --- |
| 2019 2 4 | CYTOPOINT | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | ES/2/17/205 | 2019 2 6 |
| 2019 2 4 | Zycortal | Dechra Regulatory B.V.
  Handelsweg 25, 5531 AE Bladel, Nederland | ES/2/15/189 | 2019 2 6 |
| 2019 2 5 | Bravecto | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | ES/2/13/158 | 2019 2 7 |
| 2019 2 5 | Equisolon | Le Vet B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | ES/2/14/161 | 2019 2 7 |
| 2019 2 8 | Halagon | Emdoka bvba
  J. Lijsenstraat 16, 2321 Hoogstraten, België | ES/2/16/201 | 2019 2 12 |
| 2019 2 8 | STARTVAC | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | ES/2/08/092 | 2019 2 12 |
| 2019 2 8 | Vaxxitek HVT + IBD | Merial
  29 avenue Tony Garnier, 69007 Lyon, France | ES/2/02/032 | 2019 2 12 |
| 2019 2 8 | Vectra Felis | Ceva Santé Animale
  10 avenue de la Ballastière, 33500 Libourne, France | ES/2/14/165 | 2019 2 12 |
| 2019 2 21 | BLUEVAC BTV8 | CZ Veterinaria, S.A.
  La Relva s/n, P.O. Box 16, 36400 Porriño, España | ES/2/11/122 | 2019 2 25 |
| 2019 2 21 | Zulvac BTV | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | ES/2/17/207 | 2019 2 25 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2019 2 4

CYTOPOINT

Zoetis Belgium S.A.

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

ES/2/17/205

2019 2 6

2019 2 4

Zycortal

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

ES/2/15/189

2019 2 6

2019 2 5

Bravecto

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

ES/2/13/158

2019 2 7

2019 2 5

Equisolon

Le Vet B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

ES/2/14/161

2019 2 7

2019 2 8

Halagon

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

ES/2/16/201

2019 2 12

2019 2 8

STARTVAC

Laboratorios Hipra, S.A.

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

ES/2/08/092

2019 2 12

2019 2 8

Vaxxitek HVT + IBD

Merial

29 avenue Tony Garnier, 69007 Lyon, France

ES/2/02/032

2019 2 12

2019 2 8

Vectra Felis

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

ES/2/14/165

2019 2 12

2019 2 21

BLUEVAC BTV8

CZ Veterinaria, S.A.

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

ES/2/11/122

2019 2 25

2019 2 21

Zulvac BTV

Zoetis Belgium S.A.

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

ES/2/17/207

2019 2 25

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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