# Europos Sąjungos C 101/2020

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 101 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 63 metai2020m. kovo 27d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 101

Leidimas lietuvių kalba

Informacija ir pranešimai

63 metai2020m. kovo 27d.

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| Turinys | Puslapis |
| --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2020/C 101/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2020 m. vasario 1 d. iki 2020 m. vasario 29 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

2020/C 101/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2020 m. vasario 1 d. iki 2020 m. vasario 29 d.(Paskelbta pagal Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 13 straipsnį arba 38 straipsnį)

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

1

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

LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 27.3.2020 | LT | Europos Sąjungos oficialusis leidinys | C 101/1 |
| --- | --- | --- | --- |

27.3.2020

LT

Europos Sąjungos oficialusis leidinys

C 101/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2020 m. vasario 1 d. iki 2020 m. vasario 29 d.

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

(2020/C 101/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2020 2 13 | Amsparity | adalimumabs | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/19/1415 | Injekcinis tirpalas | L04AB04 | 2020 2 17 |
| 2020 2 13 | Azacitidine Accord | Azacitidinas | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | ES/1/19/1413 | Milteliai injekcinei suspensijai | L01BC07 | 2020 2 17 |
| 2020 2 13 | Beovu | brolucizumabas | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/19/1417 | Injekcinis tirpalas | S01LA06 | 2020 2 17 |
| 2020 2 13 | Dexmedetomidine Accord | deksmedetomidinas | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | ES/1/19/1418 | Koncentratas infuziniam tirpalui | N05CM18 | 2020 2 17 |
| 2020 2 13 | Recarbrio | imipenemas/cilastatinas/relebaktamas | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/19/1420 | Milteliai infuziniam tirpalui | J01DH56 | 2020 2 17 |

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

2020 2 13

Amsparity

adalimumabs

Pfizer Europe MA EEIG

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

ES/1/19/1415

Injekcinis tirpalas

L04AB04

2020 2 17

2020 2 13

Azacitidine Accord

Azacitidinas

Accord Healthcare S.L.U.

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

ES/1/19/1413

Milteliai injekcinei suspensijai

L01BC07

2020 2 17

2020 2 13

Beovu

brolucizumabas

Novartis Europharm Limited

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

ES/1/19/1417

Injekcinis tirpalas

S01LA06

2020 2 17

2020 2 13

Dexmedetomidine Accord

deksmedetomidinas

Accord Healthcare S.L.U.

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

ES/1/19/1418

Koncentratas infuziniam tirpalui

N05CM18

2020 2 17

2020 2 13

Recarbrio

imipenemas/cilastatinas/relebaktamas

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/19/1420

Milteliai infuziniam tirpalui

J01DH56

2020 2 17

—   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 |
| --- | --- | --- | --- | --- |
| 2020 2 4 | Ceprotin | Takeda Manufacturing Austria AG
  Industriestraße 67, 1221 Wien, Österreich | ES/1/01/190 | 2020 2 6 |
| 2020 2 4 | CONTROLOC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | ES/1/09/515 | 2020 2 6 |
| 2020 2 4 | ellaOne | Laboratoire HRA Pharma
  200 avenue de Paris, 92320 Chatillon, France | ES/1/09/522 | 2020 2 6 |
| 2020 2 4 | 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 | 2020 2 6 |
| 2020 2 4 | Lacosamide Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/17/1230 | 2020 2 6 |
| 2020 2 4 | LIFMIOR | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/16/1165 | 2020 2 6 |
| 2020 2 4 | Mekinist | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/14/931 | 2020 2 6 |
| 2020 2 4 | PANTOZOL Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | ES/1/09/517 | 2020 2 6 |
| 2020 2 4 | Suboxone | Indivior Europe Limited
  27 Windsor Place, Dublin 2, Ireland | ES/1/06/359 | 2020 2 6 |
| 2020 2 4 | Ucedane | Eurocept International B.V.
  Trapgans 5, 1244 RL Ankeveen, Nederland | ES/1/17/1202 | 2020 2 6 |
| 2020 2 4 | Ziagen | ViiV Healthcare BV
  Huis ter Heideweg 62, 3705 LZ Zeist, Nederland | ES/1/99/112 | 2020 2 6 |
| 2020 2 4 | Zoely | Theramex Ireland Limited
  3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland | ES/1/11/690 | 2020 2 6 |
| 2020 2 6 | Aranesp | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | ES/1/01/185 | 2020 2 10 |
| 2020 2 6 | Bronchitol | Pharmaxis Europe Limited
  108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland | ES/1/12/760 | 2020 2 10 |
| 2020 2 6 | Fasenra | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/17/1252 | 2020 2 10 |
| 2020 2 6 | Granpidam | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España | ES/1/16/1137 | 2020 2 10 |
| 2020 2 6 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/14/930 | 2020 2 10 |
| 2020 2 6 | Neuraceq | Life Radiopharma Berlin GmbH
  Max-Planck-Straße 4, 12489 Berlin, Deutschland | ES/1/13/906 | 2020 2 10 |
| 2020 2 6 | SOMAC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | ES/1/09/516 | 2020 2 10 |
| 2020 2 6 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/14/918 | 2020 2 10 |
| 2020 2 10 | Inhixa | Techdow Pharma Netherlands B.V.
  Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland | ES/1/16/1132 | 2020 2 12 |
| 2020 2 11 | Alimta | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/04/290 | 2020 2 13 |
| 2020 2 11 | ALPROLIX | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | ES/1/16/1098 | 2020 2 13 |
| 2020 2 11 | 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 | 2020 2 13 |
| 2020 2 11 | OCALIVA | Intercept Pharma International Limited
  Ormond Building, 31–36 Ormond Quay Upper, Dublin 7, Ireland | ES/1/16/1139 | 2020 2 13 |
| 2020 2 11 | Orkambi | Vertex Pharmaceuticals (Ireland) Limited
  28–32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | ES/1/15/1059 | 2020 2 13 |
| 2020 2 11 | Pemetrexed Fresenius Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | ES/1/16/1115 | 2020 2 13 |
| 2020 2 11 | Rebetol | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/99/107 | 2020 2 13 |
| 2020 2 11 | Symkevi | Vertex Pharmaceuticals (Ireland) Limited
  28–32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | ES/1/18/1306 | 2020 2 13 |
| 2020 2 11 | Zeffix | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/99/114 | 2020 2 13 |
| 2020 2 11 | Zevalin | Ceft Biopharma s.r.o
  Trtinova 260/1 Cakovice, 196 00 Praha 9, Česká republika | ES/1/03/264 | 2020 2 13 |
| 2020 2 12 | Zoledronic acid Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/12/800 | 2020 2 14 |
| 2020 2 13 | Aimovig | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/18/1293 | 2020 2 17 |
| 2020 2 13 | Bosulif | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/13/818 | 2020 2 17 |
| 2020 2 13 | Brineura | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | ES/1/17/1192 | 2020 2 17 |
| 2020 2 13 | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | ES/1/11/733 | 2020 2 17 |
| 2020 2 13 | Duloxetine Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/15/1010 | 2020 2 17 |
| 2020 2 13 | Ebixa | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | ES/1/02/219 | 2020 2 17 |
| 2020 2 13 | IBRANCE | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/16/1147 | 2020 2 17 |
| 2020 2 13 | Mvasi | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | ES/1/17/1246 | 2020 2 17 |
| 2020 2 13 | Quinsair | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | ES/1/14/973 | 2020 2 17 |
| 2020 2 13 | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | ES/1/06/363 | 2020 2 17 |
| 2020 2 13 | Tamiflu | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | ES/1/02/222 | 2020 2 17 |
| 2020 2 13 | Ventavis | Bayer AG
  D-51368 Leverkusen, Deutschland | ES/1/03/255 | 2020 2 17 |
| 2020 2 17 | Adempas | Bayer AG
  D-51368 Leverkusen, Deutschland | ES/1/13/907 | 2020 2 19 |
| 2020 2 17 | Atripla | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | ES/1/07/430 | 2020 2 19 |
| 2020 2 17 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland | ES/1/11/691 | 2020 2 19 |
| 2020 2 17 | Sifrol | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/97/050 | 2020 2 19 |
| 2020 2 17 | Suliqua | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | ES/1/16/1157 | 2020 2 19 |
| 2020 2 17 | Tacforius | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/17/1244 | 2020 3 2 |
| 2020 2 17 | Vyndaqel | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/11/717 | 2020 2 19 |
| 2020 2 18 | Zypadhera | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/08/479 | 2020 2 20 |
| 2020 2 21 | Cholib | Mylan IRE Healthcare Ltd
  Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland | ES/1/13/866 | 2020 2 25 |
| 2020 2 21 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | ES/1/13/890 | 2020 2 25 |
| 2020 2 21 | Docetaxel Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/12/769 | 2020 2 25 |
| 2020 2 21 | 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 | 2020 2 25 |
| 2020 2 21 | Holoclar | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | ES/1/14/987 | 2020 2 25 |
| 2020 2 21 | Imfinzi | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/18/1322 | 2020 2 18 |
| 2020 2 21 | Lyrica | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/04/279 | 2020 2 25 |
| 2020 2 21 | Mirapexin | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | ES/1/97/051 | 2020 2 25 |
| 2020 2 21 | Resolor | Shire Pharmaceuticals Ireland Limited
  Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland | ES/1/09/581 | 2020 2 25 |
| 2020 2 21 | Trelegy Ellipta | GlaxoSmithKline Trading Services Limited
  Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland | ES/1/17/1236 | 2020 2 25 |
| 2020 2 21 | 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 | 2020 2 25 |
| 2020 2 21 | Zalasta | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | ES/1/07/415 | 2020 2 25 |
| 2020 2 21 | Zyprexa | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/96/022 | 2020 2 25 |
| 2020 2 21 | Zyprexa Velotab | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/99/125 | 2020 2 25 |
| 2020 2 24 | Docetaxel Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | ES/1/12/770 | 2020 2 26 |
| 2020 2 24 | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | ES/1/15/993 | 2020 2 26 |
| 2020 2 24 | Slenyto | RAD Neurim Pharmaceuticals EEC SARL
  4 rue de Marivaux, 75002 Paris, France | ES/1/18/1318 | 2020 2 26 |
| 2020 2 25 | Aripiprazole Mylan Pharma | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/15/1005 | 2020 2 27 |
| 2020 2 28 | Advagraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | ES/1/07/387 | 2020 3 3 |
| 2020 2 28 | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | ES/1/12/812 | 2020 3 3 |
| 2020 2 28 | Cuprymina | A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.
  Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia | ES/1/12/784 | 2020 3 3 |
| 2020 2 28 | Hetlioz | Vanda Pharmaceuticals Germany GmbH
  Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland | ES/1/15/1008 | 2020 3 3 |
| 2020 2 28 | Januvia | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/07/383 | 2020 3 3 |
| 2020 2 28 | Ledaga | Helsinn Birex Pharmaceuticals Ltd.
  Damastown, Mulhuddart, Dublin 15, Ireland | ES/1/16/1171 | 2020 3 3 |
| 2020 2 28 | Modigraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | ES/1/09/523 | 2020 3 3 |
| 2020 2 28 | Pegfilgrastim Mundipharma | Mundipharma Corporation (Ireland) Limited
  Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland | ES/1/19/1409 | 2020 3 3 |
| 2020 2 28 | 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 | 2020 3 3 |
| 2020 2 28 | Pemetrexed Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/15/1034 | 2020 3 3 |
| 2020 2 28 | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | ES/1/09/546 | 2020 3 3 |
| 2020 2 28 | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland | ES/1/13/857 | 2020 3 3 |
| 2020 2 28 | Xerava | Tetraphase Pharmaceuticals Ireland Limited
  10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | ES/1/18/1312 | 2020 3 3 |
| 2020 2 28 | Xeristar | Esteve Pharmaceuticals S.A.
  Passeig de la Zona Franca, 109, 08038 Barcelona, España | ES/1/04/297 | 2020 3 3 |
| 2020 2 28 | Xolair | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/05/319 | 2020 3 3 |
| 2020 2 28 | Zoledronic acid Accord | Accord Healthcare S.L.U.
  World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España | ES/1/13/834 | 2020 3 3 |
| 2020 2 28 | Zydelig | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | ES/1/14/938 | 2020 3 3 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2020 2 4

Ceprotin

Takeda Manufacturing Austria AG

Industriestraße 67, 1221 Wien, Österreich

ES/1/01/190

2020 2 6

2020 2 4

CONTROLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

ES/1/09/515

2020 2 6

2020 2 4

ellaOne

Laboratoire HRA Pharma

200 avenue de Paris, 92320 Chatillon, France

ES/1/09/522

2020 2 6

2020 2 4

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

2020 2 6

2020 2 4

Lacosamide Accord

Accord Healthcare S.L.U.

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

ES/1/17/1230

2020 2 6

2020 2 4

LIFMIOR

Pfizer Europe MA EEIG

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

ES/1/16/1165

2020 2 6

2020 2 4

Mekinist

Novartis Europharm Limited

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

ES/1/14/931

2020 2 6

2020 2 4

PANTOZOL Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

ES/1/09/517

2020 2 6

2020 2 4

Suboxone

Indivior Europe Limited

27 Windsor Place, Dublin 2, Ireland

ES/1/06/359

2020 2 6

2020 2 4

Ucedane

Eurocept International B.V.

Trapgans 5, 1244 RL Ankeveen, Nederland

ES/1/17/1202

2020 2 6

2020 2 4

Ziagen

ViiV Healthcare BV

Huis ter Heideweg 62, 3705 LZ Zeist, Nederland

ES/1/99/112

2020 2 6

2020 2 4

Zoely

Theramex Ireland Limited

3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland

ES/1/11/690

2020 2 6

2020 2 6

Aranesp

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

ES/1/01/185

2020 2 10

2020 2 6

Bronchitol

Pharmaxis Europe Limited

108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland

ES/1/12/760

2020 2 10

2020 2 6

Fasenra

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/17/1252

2020 2 10

2020 2 6

Granpidam

Accord Healthcare S.L.U.

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

ES/1/16/1137

2020 2 10

2020 2 6

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/14/930

2020 2 10

2020 2 6

Neuraceq

Life Radiopharma Berlin GmbH

Max-Planck-Straße 4, 12489 Berlin, Deutschland

ES/1/13/906

2020 2 10

2020 2 6

SOMAC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

ES/1/09/516

2020 2 10

2020 2 6

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/14/918

2020 2 10

2020 2 10

Inhixa

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland

ES/1/16/1132

2020 2 12

2020 2 11

Alimta

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/04/290

2020 2 13

2020 2 11

ALPROLIX

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

ES/1/16/1098

2020 2 13

2020 2 11

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

2020 2 13

2020 2 11

OCALIVA

Intercept Pharma International Limited

Ormond Building, 31–36 Ormond Quay Upper, Dublin 7, Ireland

ES/1/16/1139

2020 2 13

2020 2 11

Orkambi

Vertex Pharmaceuticals (Ireland) Limited

28–32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

ES/1/15/1059

2020 2 13

2020 2 11

Pemetrexed Fresenius Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

ES/1/16/1115

2020 2 13

2020 2 11

Rebetol

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/99/107

2020 2 13

2020 2 11

Symkevi

Vertex Pharmaceuticals (Ireland) Limited

28–32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland

ES/1/18/1306

2020 2 13

2020 2 11

Zeffix

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/99/114

2020 2 13

2020 2 11

Zevalin

Ceft Biopharma s.r.o

Trtinova 260/1 Cakovice, 196 00 Praha 9, Česká republika

ES/1/03/264

2020 2 13

2020 2 12

Zoledronic acid Hospira

Pfizer Europe MA EEIG

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

ES/1/12/800

2020 2 14

2020 2 13

Aimovig

Novartis Europharm Limited

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

ES/1/18/1293

2020 2 17

2020 2 13

Bosulif

Pfizer Europe MA EEIG

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

ES/1/13/818

2020 2 17

2020 2 13

Brineura

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

ES/1/17/1192

2020 2 17

2020 2 13

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

ES/1/11/733

2020 2 17

2020 2 13

Duloxetine Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/15/1010

2020 2 17

2020 2 13

Ebixa

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

ES/1/02/219

2020 2 17

2020 2 13

IBRANCE

Pfizer Europe MA EEIG

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

ES/1/16/1147

2020 2 17

2020 2 13

Mvasi

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

ES/1/17/1246

2020 2 17

2020 2 13

Quinsair

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

ES/1/14/973

2020 2 17

2020 2 13

Sprycel

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

ES/1/06/363

2020 2 17

2020 2 13

Tamiflu

Roche Registration GmbH

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

ES/1/02/222

2020 2 17

2020 2 13

Ventavis

Bayer AG

D-51368 Leverkusen, Deutschland

ES/1/03/255

2020 2 17

2020 2 17

Adempas

Bayer AG

D-51368 Leverkusen, Deutschland

ES/1/13/907

2020 2 19

2020 2 17

Atripla

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

ES/1/07/430

2020 2 19

2020 2 17

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

ES/1/11/691

2020 2 19

2020 2 17

Sifrol

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/97/050

2020 2 19

2020 2 17

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

ES/1/16/1157

2020 2 19

2020 2 17

Tacforius

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/17/1244

2020 3 2

2020 2 17

Vyndaqel

Pfizer Europe MA EEIG

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

ES/1/11/717

2020 2 19

2020 2 18

Zypadhera

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/08/479

2020 2 20

2020 2 21

Cholib

Mylan IRE Healthcare Ltd

Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ES/1/13/866

2020 2 25

2020 2 21

Cometriq

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

ES/1/13/890

2020 2 25

2020 2 21

Docetaxel Accord

Accord Healthcare S.L.U.

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

ES/1/12/769

2020 2 25

2020 2 21

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

2020 2 25

2020 2 21

Holoclar

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

ES/1/14/987

2020 2 25

2020 2 21

Imfinzi

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/18/1322

2020 2 18

2020 2 21

Lyrica

Pfizer Europe MA EEIG

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

ES/1/04/279

2020 2 25

2020 2 21

Mirapexin

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

ES/1/97/051

2020 2 25

2020 2 21

Resolor

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland

ES/1/09/581

2020 2 25

2020 2 21

Trelegy Ellipta

GlaxoSmithKline Trading Services Limited

Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland

ES/1/17/1236

2020 2 25

2020 2 21

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

2020 2 25

2020 2 21

Zalasta

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

ES/1/07/415

2020 2 25

2020 2 21

Zyprexa

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/96/022

2020 2 25

2020 2 21

Zyprexa Velotab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/99/125

2020 2 25

2020 2 24

Docetaxel Kabi

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland

ES/1/12/770

2020 2 26

2020 2 24

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

ES/1/15/993

2020 2 26

2020 2 24

Slenyto

RAD Neurim Pharmaceuticals EEC SARL

4 rue de Marivaux, 75002 Paris, France

ES/1/18/1318

2020 2 26

2020 2 25

Aripiprazole Mylan Pharma

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/15/1005

2020 2 27

2020 2 28

Advagraf

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

ES/1/07/387

2020 3 3

2020 2 28

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

ES/1/12/812

2020 3 3

2020 2 28

Cuprymina

A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L.

Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia

ES/1/12/784

2020 3 3

2020 2 28

Hetlioz

Vanda Pharmaceuticals Germany GmbH

Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland

ES/1/15/1008

2020 3 3

2020 2 28

Januvia

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/07/383

2020 3 3

2020 2 28

Ledaga

Helsinn Birex Pharmaceuticals Ltd.

Damastown, Mulhuddart, Dublin 15, Ireland

ES/1/16/1171

2020 3 3

2020 2 28

Modigraf

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

ES/1/09/523

2020 3 3

2020 2 28

Pegfilgrastim Mundipharma

Mundipharma Corporation (Ireland) Limited

Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland

ES/1/19/1409

2020 3 3

2020 2 28

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

2020 3 3

2020 2 28

Pemetrexed Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/15/1034

2020 3 3

2020 2 28

Simponi

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

ES/1/09/546

2020 3 3

2020 2 28

Voncento

CSL Behring GmbH

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

ES/1/13/857

2020 3 3

2020 2 28

Xerava

Tetraphase Pharmaceuticals Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

ES/1/18/1312

2020 3 3

2020 2 28

Xeristar

Esteve Pharmaceuticals S.A.

Passeig de la Zona Franca, 109, 08038 Barcelona, España

ES/1/04/297

2020 3 3

2020 2 28

Xolair

Novartis Europharm Limited

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

ES/1/05/319

2020 3 3

2020 2 28

Zoledronic acid Accord

Accord Healthcare S.L.U.

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

ES/1/13/834

2020 3 3

2020 2 28

Zydelig

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

ES/1/14/938

2020 3 3

—   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 |
| --- | --- | --- | --- | --- |
| 2020 2 11 | Picato | LEO Laboratories Ltd
  285 Cashel Road, Crumlin, Dublin 12, Ireland | ES/1/12/796 | 2020 2 13 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2020 2 11

Picato

LEO Laboratories Ltd

285 Cashel Road, Crumlin, Dublin 12, Ireland

ES/1/12/796

2020 2 13

—   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 |
| --- | --- | --- | --- | --- |
| 2020 2 4 | Clevor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | ES/2/17/222 | 2020 2 6 |
| 2020 2 11 | Halagon | Emdoka bvba
  J. Lijsenstraat 16, 2321 Hoogstraten, België | ES/2/16/201 | 2020 2 13 |
| 2020 2 11 | Meloxidyl | Ceva Santé Animale
  10 avenue de La Ballastière, 33500 Libourne, France | ES/2/06/070 | 2020 2 13 |
| 2020 2 11 | Oxyglobin | OPK Biotech Netherlands BV
  Teleportboulevard 140, 1043 EJ Amsterdam, Nederland | ES/2/99/015 | 2020 2 14 |
| 2020 2 11 | Palladia | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | ES/2/09/100 | 2020 2 13 |
| 2020 2 17 | Zulvac 1 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | ES/2/11/130 | 2020 2 19 |
| 2020 2 17 | Zulvac 1 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | ES/2/11/131 | 2020 2 19 |
| 2020 2 18 | Emdocam | Emdoka bvba
  J. Lijsenstraat 16, 2321 Hoogstraten, België | ES/2/11/128 | 2020 2 20 |
| 2020 2 18 | Zycortal | Dechra Regulatory B.V.
  Handelsweg 25, 5531 AE Bladel, Nederland | ES/2/15/189 | 2020 2 20 |
| 2020 2 26 | Porcilis ColiClos | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | ES/2/12/141 | 2020 2 28 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2020 2 4

Clevor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

ES/2/17/222

2020 2 6

2020 2 11

Halagon

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

ES/2/16/201

2020 2 13

2020 2 11

Meloxidyl

Ceva Santé Animale

10 avenue de La Ballastière, 33500 Libourne, France

ES/2/06/070

2020 2 13

2020 2 11

Oxyglobin

OPK Biotech Netherlands BV

Teleportboulevard 140, 1043 EJ Amsterdam, Nederland

ES/2/99/015

2020 2 14

2020 2 11

Palladia

Zoetis Belgium S.A.

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

ES/2/09/100

2020 2 13

2020 2 17

Zulvac 1 Bovis

Zoetis Belgium S.A.

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

ES/2/11/130

2020 2 19

2020 2 17

Zulvac 1 Ovis

Zoetis Belgium S.A.

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

ES/2/11/131

2020 2 19

2020 2 18

Emdocam

Emdoka bvba

J. Lijsenstraat 16, 2321 Hoogstraten, België

ES/2/11/128

2020 2 20

2020 2 18

Zycortal

Dechra Regulatory B.V.

Handelsweg 25, 5531 AE Bladel, Nederland

ES/2/15/189

2020 2 20

2020 2 26

Porcilis ColiClos

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

ES/2/12/141

2020 2 28

—   Rinkodaros leidimo atšaukimas (Europos Parlamento ir Tarybos reglamento (EB) Nr. 726/2004 38 straipsnis)

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2020 2 18 | Zulvac 1 Bovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | ES/2/11/130 | 2020 2 20 |
| 2020 2 18 | Zulvac 1 Ovis | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | ES/2/11/131 | 2020 2 20 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2020 2 18

Zulvac 1 Bovis

Zoetis Belgium S.A.

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

ES/2/11/130

2020 2 20

2020 2 18

Zulvac 1 Ovis

Zoetis Belgium S.A.

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

ES/2/11/131

2020 2 20

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

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| NETHERLANDS |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

NETHERLANDS

---

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

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