# Europos Sąjungos C 465/2018

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 465 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 61 metai2018m. gruodžio 27d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 465

Leidimas lietuvių kalba

Informacija ir pranešimai

61 metai2018m. gruodžio 27d.

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| Turinys | Puslapis |
| --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2018/C 465/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. lapkričio 1 d. iki 2018 m. lapkričio 30 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

2018/C 465/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. lapkričio 1 d. iki 2018 m. lapkričio 30 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 | |
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LT

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IV Pranešimai

EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI

Europos Komisija

| 27.12.2018 | LT | Europos Sąjungos oficialusis leidinys | C 465/1 |
| --- | --- | --- | --- |

27.12.2018

LT

Europos Sąjungos oficialusis leidinys

C 465/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. lapkričio 1 d. iki 2018 m. lapkričio 30 d.

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

(2018/C 465/01)

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

—

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

| Sprendimo data | Vaisto pavadinimas | INN (Tarptautinis nepatentuotas pavadinimas) | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Farmacinė forma | ATC kodas (Anatominis terapinis cheminis kodas) | Pranešimo data |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2018 11 14 | Emgality | galkanezumabas | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | ES/1/18/1330 | Injekcinis tirpalas | N02CX08 | 2018 11 16 |
| 2018 11 20 | Apealea | paklitakselis | Oasmia Pharmaceutical AB
  Vallongatan 1, 75228 Uppsala, Sverige | ES/1/18/1292 | Milteliai infuziniam tirpalui | L01CD01 | 2018 11 22 |
| 2018 11 20 | Buvidal | Buprenorfinas | Camurus AB
  Ideon Science Park, 223 70 Lund, Sverige | ES/1/18/1336 | Pailginto atpalaidavimo injekcinis tirpalas | N07BC01 | 2018 11 22 |
| 2018 11 20 | Fulphila | pegfilgrastimas | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/18/1329 | Injekcinis tirpalas | L03AA13 | 2018 11 22 |
| 2018 11 20 | Pelmeg | pegfilgrastimas (pegfilgrastim) | Cinfa Biotech S.L.
  Travesía de Roncesvalles 1, 31699 Olloki (Navarra), España | ES/1/18/1328 | Injekcinis tirpalas | L03AA13 | 2018 11 22 |
| 2018 11 20 | Vabomere | Meropenemas, vaborbaktamas | Rempex London Limited
  115L Milton Park, Abingdon, Oxfordshire, OX14 4SA United Kingdom | ES/1/18/1334 | Milteliai koncentratui infuziniam tirpalui | J01DH52 | 2018 11 22 |
| 2018 11 20 | Venclyxto | Venetoklaksas | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | ES/1/16/1138 | Plėvele dengta tabletė | L01XX52 | 2018 11 22 |
| 2018 11 22 | Alunbrig | Brigatinibas | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | ES/1/18/1264 | Plėvele dengta tabletė | L01XE43 | 2018 11 26 |
| 2018 11 22 | Delstrigo | doravirinas/lamivudinas/tenofoviro dizoproksilis | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/18/1333 | Plėvele dengta tabletė | J05AG24 | 2018 11 26 |
| 2018 11 22 | Jivi | damoktokogas alfa pegolas | Bayer AG
  D-51368 Leverkusen, Deutschland | ES/1/18/1324 | Milteliai ir tirpiklis injekciniam tirpalui | B02BD02 | 2018 11 26 |
| 2018 11 22 | Luxturna | voretigenas neparvovekas | Spark Therapeutics Ireland Ltd
  Studio G3,The Tower, Trinity Technology & Enterprise Campus, Pearse Street, Dublin 2, Ireland | ES/1/18/1331 | Koncentratas ir skiediklis injekciniam tirpalui ruošti | Pending | 2018 12 5 |
| 2018 11 22 | Pifeltro | doravirinas | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | ES/1/18/1332 | Plėvele dengta tabletė | J05AG06 | 2018 11 27 |
| 2018 11 22 | Poteligeo | Mogamulizumabas | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | ES/1/18/1335 | Koncentratas infuziniam tirpalui | L01XC25 | 2018 11 26 |
| 2018 11 22 | TAKHZYRO | lanadelumabas | Shire Pharmaceuticals Ireland Limited
  Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, IRELAND | ES/1/18/1340 | Injekcinis tirpalas | B06AC05 | 2018 11 26 |
| 2018 11 22 | Ziextenzo | pegfilgrastim | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | ES/1/18/1327 | Injekcinis tirpalas | L03AA13 | 2018 11 26 |

Sprendimo data

Vaisto pavadinimas

INN (Tarptautinis nepatentuotas pavadinimas)

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Farmacinė forma

ATC kodas (Anatominis terapinis cheminis kodas)

Pranešimo data

2018 11 14

Emgality

galkanezumabas

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

ES/1/18/1330

Injekcinis tirpalas

N02CX08

2018 11 16

2018 11 20

Apealea

paklitakselis

Oasmia Pharmaceutical AB

Vallongatan 1, 75228 Uppsala, Sverige

ES/1/18/1292

Milteliai infuziniam tirpalui

L01CD01

2018 11 22

2018 11 20

Buvidal

Buprenorfinas

Camurus AB

Ideon Science Park, 223 70 Lund, Sverige

ES/1/18/1336

Pailginto atpalaidavimo injekcinis tirpalas

N07BC01

2018 11 22

2018 11 20

Fulphila

pegfilgrastimas

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/18/1329

Injekcinis tirpalas

L03AA13

2018 11 22

2018 11 20

Pelmeg

pegfilgrastimas (pegfilgrastim)

Cinfa Biotech S.L.

Travesía de Roncesvalles 1, 31699 Olloki (Navarra), España

ES/1/18/1328

Injekcinis tirpalas

L03AA13

2018 11 22

2018 11 20

Vabomere

Meropenemas, vaborbaktamas

Rempex London Limited

115L Milton Park, Abingdon, Oxfordshire, OX14 4SA United Kingdom

ES/1/18/1334

Milteliai koncentratui infuziniam tirpalui

J01DH52

2018 11 22

2018 11 20

Venclyxto

Venetoklaksas

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

ES/1/16/1138

Plėvele dengta tabletė

L01XX52

2018 11 22

2018 11 22

Alunbrig

Brigatinibas

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

ES/1/18/1264

Plėvele dengta tabletė

L01XE43

2018 11 26

2018 11 22

Delstrigo

doravirinas/lamivudinas/tenofoviro dizoproksilis

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/18/1333

Plėvele dengta tabletė

J05AG24

2018 11 26

2018 11 22

Jivi

damoktokogas alfa pegolas

Bayer AG

D-51368 Leverkusen, Deutschland

ES/1/18/1324

Milteliai ir tirpiklis injekciniam tirpalui

B02BD02

2018 11 26

2018 11 22

Luxturna

voretigenas neparvovekas

Spark Therapeutics Ireland Ltd

Studio G3,The Tower, Trinity Technology & Enterprise Campus, Pearse Street, Dublin 2, Ireland

ES/1/18/1331

Koncentratas ir skiediklis injekciniam tirpalui ruošti

Pending

2018 12 5

2018 11 22

Pifeltro

doravirinas

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

ES/1/18/1332

Plėvele dengta tabletė

J05AG06

2018 11 27

2018 11 22

Poteligeo

Mogamulizumabas

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

ES/1/18/1335

Koncentratas infuziniam tirpalui

L01XC25

2018 11 26

2018 11 22

TAKHZYRO

lanadelumabas

Shire Pharmaceuticals Ireland Limited

Block 2 & 3 Miesian Plaza, 50–58 Baggot Street Lower, Dublin 2, IRELAND

ES/1/18/1340

Injekcinis tirpalas

B06AC05

2018 11 26

2018 11 22

Ziextenzo

pegfilgrastim

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

ES/1/18/1327

Injekcinis tirpalas

L03AA13

2018 11 26

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

—

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

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2018 11 8 | Benepali | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | ES/1/15/1074 | 2018 11 13 |
| 2018 11 8 | Benepali | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | ES/1/15/1074 | 2018 11 15 |
| 2018 11 8 | Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | ES/1/17/1210 | 2018 11 12 |
| 2018 11 8 | Flixabi | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | ES/1/16/1106 | 2018 11 15 |
| 2018 11 8 | Irbesartan HCT Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | ES/1/06/377 | 2018 11 12 |
| 2018 11 8 | Neupro | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | ES/1/05/331 | 2018 11 12 |
| 2018 11 8 | Ontruzant | Samsung Bioepis NL B.V.
  Olof Palmestraat 10, 2616 LR Delft, Nederland | ES/1/17/1241 | 2018 11 16 |
| 2018 11 8 | Ruconest | Pharming Group N.V.
  Darwinweg 24, 2333 CR Leiden, Nederland | ES/1/10/641 | 2018 11 12 |
| 2018 11 8 | Spinraza | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | ES/1/17/1188 | 2018 11 12 |
| 2018 11 8 | Tracleer | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/02/220 | 2018 11 12 |
| 2018 11 8 | Xeljanz | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/17/1178 | 2018 11 12 |
| 2018 11 12 | Bemfola | Gedeon Richter Plc.
  Gyömrői út 19–21., 1103 Budapest, Magyarország | ES/1/13/909 | 2018 11 14 |
| 2018 11 12 | CABOMETYX | Ipsen Pharma
  65 quai Georges Gorse, 92100 Boulogne-Billancourt, France | ES/1/16/1136 | 2018 11 14 |
| 2018 11 12 | Clopidogrel ratiopharm | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/14/975 | 2018 11 14 |
| 2018 11 12 | Desloratadine ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | ES/1/11/746 | 2018 11 14 |
| 2018 11 12 | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/15/1051 | 2018 11 14 |
| 2018 11 12 | Edistride | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/15/1052 | 2018 11 14 |
| 2018 11 12 | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | ES/1/14/983 | 2018 11 14 |
| 2018 11 12 | Forxiga | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/12/795 | 2018 11 14 |
| 2018 11 12 | Jinarc | Otsuka Pharmaceutical Netherlands B.V.
  Herikerbergweg 292, 1101 CT, Amsterdam, Nederland | ES/1/15/1000 | 2018 11 14 |
| 2018 11 12 | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/14/899 | 2018 11 14 |
| 2018 11 12 | Olanzapinas Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | ES/1/08/475 | 2018 12 7 |
| 2018 11 12 | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/13/900 | 2018 11 14 |
| 2018 11 14 | Benlysta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/11/700 | 2018 11 16 |
| 2018 11 14 | Daptomycin Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom | ES/1/17/1175 | 2018 11 16 |
| 2018 11 14 | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/14/922 | 2018 11 16 |
| 2018 11 14 | Izba | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/13/905 | 2018 11 16 |
| 2018 11 14 | Latuda | Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A.
  Viale Amelia 70, 00181 Roma, Italia | ES/1/14/913 | 2018 11 16 |
| 2018 11 14 | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/14/899 | 2018 11 16 |
| 2018 11 14 | Tecfidera | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | ES/1/13/837 | 2018 11 16 |
| 2018 11 20 | Brineura | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | ES/1/17/1192 | 2018 11 22 |
| 2018 11 20 | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | ES/1/13/891 | 2018 11 22 |
| 2018 11 20 | Emtricitabine/Tenofovir disoproxil Krka | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | ES/1/16/1151 | 2018 11 22 |
| 2018 11 20 | Fluenz Tetra | AstraZeneca AB
  151 85 Södertälje, Sverige | ES/1/13/887 | 2018 11 22 |
| 2018 11 20 | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/14/922 | 2018 11 22 |
| 2018 11 20 | Levetiracetam Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/13/889 | 2018 11 22 |
| 2018 11 20 | Neuraceq | Life Radiopharma Berlin GmbH
  Max-Planck-Straße 4, 12489 Berlin, Deutschland | ES/1/13/906 | 2018 11 22 |
| 2018 11 20 | NovoSeven | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | ES/1/96/006 | 2018 11 22 |
| 2018 11 20 | Orfadin | Swedish Orphan Biovitrum International AB
  112 76 Stockholm, Sverige | ES/1/04/303 | 2018 11 23 |
| 2018 11 20 | Ozurdex | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | ES/1/10/638 | 2018 11 22 |
| 2018 11 20 | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/06/380 | 2018 11 22 |
| 2018 11 20 | Rapiscan | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | ES/1/10/643 | 2018 11 22 |
| 2018 11 20 | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/14/967 | 2018 11 22 |
| 2018 11 20 | Selincro | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | ES/1/12/815 | 2018 11 22 |
| 2018 11 20 | Symtuza | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | ES/1/17/1225 | 2018 11 22 |
| 2018 11 20 | Zoledronic acid Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | ES/1/13/834 | 2018 11 22 |
| 2018 11 22 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | ES/1/07/430 | 2018 11 26 |
| 2018 11 22 | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | ES/1/12/812 | 2018 11 26 |
| 2018 11 22 | Docetaxel Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | ES/1/07/384 | 2018 11 26 |
| 2018 11 22 | Efient | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | ES/1/08/503 | 2018 11 26 |
| 2018 11 22 | Erivedge | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | ES/1/13/848 | 2018 11 26 |
| 2018 11 22 | GILENYA | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | ES/1/11/677 | 2018 11 28 |
| 2018 11 22 | Inlyta | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/12/777 | 2018 11 26 |
| 2018 11 22 | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, 1030 Wien, Österreich | ES/1/08/501 | 2018 11 26 |
| 2018 11 22 | Kalydeco | Vertex Pharmaceuticals (Ireland) Limited
  28–32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | ES/1/12/782 | 2018 11 26 |
| 2018 11 22 | Kentera | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | ES/1/03/270 | 2018 11 26 |
| 2018 11 22 | Kyprolis | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | ES/1/15/1060 | 2018 11 26 |
| 2018 11 22 | Levetiracetam Hospira | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België | ES/1/13/889 | 2018 11 26 |
| 2018 11 22 | Mirvaso | Galderma International
  Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | ES/1/13/904 | 2018 11 26 |
| 2018 11 22 | Nyxoid | Mundipharma Corporation (Ireland) Limited
  Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland | ES/1/17/1238 | 2018 11 26 |
| 2018 11 22 | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | ES/1/08/462 | 2018 11 26 |
| 2018 11 22 | Soliris | Alexion Europe SAS
  1–15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | ES/1/07/393 | 2018 11 27 |
| 2018 11 22 | Synflorix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | ES/1/09/508 | 2018 11 26 |
| 2018 11 22 | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | ES/1/14/982 | 2018 11 26 |
| 2018 11 22 | Wakix | Bioprojet Pharma
  9 rue Rameau, 75002 Paris, France | ES/1/15/1068 | 2018 11 26 |
| 2018 11 22 | Zinforo | Pfizer Ireland Pharmaceuticals
  Operations Support Group, Ringaskiddy, County Cork, Ireland | ES/1/12/785 | 2018 11 26 |
| 2018 11 26 | alli | GlaxoSmithKline Dungarvan Limited
  Knockbrack, Dungarvan, Co. Waterford, Ireland | ES/1/07/401 | 2018 11 29 |
| 2018 11 26 | Anoro Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ES/1/14/898 | 2018 11 28 |
| 2018 11 26 | Darunavir Krka d.d. | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | ES/1/17/1248 | 2018 11 28 |
| 2018 11 26 | Docetaxel Zentiva | Zentiva k.s.
  U kabelovny 130, 102 37 Praha 10, Česká republika | ES/1/07/384 | 2018 11 28 |
| 2018 11 26 | Kalydeco | Vertex Pharmaceuticals (Ireland) Limited
  28–32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | ES/1/12/782 | 2018 11 28 |
| 2018 11 26 | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | ES/1/10/654 | 2018 11 28 |
| 2018 11 26 | Orkambi | Vertex Pharmaceuticals (Ireland) Limited
  28–32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland | ES/1/15/1059 | 2018 11 28 |
| 2018 11 26 | PHEBURANE | Eurocept International BV
  Trapgans 5, 1244 RL Ankeveen, Nederland | ES/1/13/822 | 2018 11 28 |
| 2018 11 26 | Zeffix | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | ES/1/99/114 | 2018 11 28 |
| 2018 11 28 | AMGEVITA | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | ES/1/16/1164 | 2018 11 30 |
| 2018 11 28 | Pregabalin Zentiva k.s | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | ES/1/16/1166 | 2018 11 30 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 11 8

Benepali

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

ES/1/15/1074

2018 11 13

2018 11 8

Benepali

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

ES/1/15/1074

2018 11 15

2018 11 8

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

ES/1/17/1210

2018 11 12

2018 11 8

Flixabi

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

ES/1/16/1106

2018 11 15

2018 11 8

Irbesartan HCT Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

ES/1/06/377

2018 11 12

2018 11 8

Neupro

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

ES/1/05/331

2018 11 12

2018 11 8

Ontruzant

Samsung Bioepis NL B.V.

Olof Palmestraat 10, 2616 LR Delft, Nederland

ES/1/17/1241

2018 11 16

2018 11 8

Ruconest

Pharming Group N.V.

Darwinweg 24, 2333 CR Leiden, Nederland

ES/1/10/641

2018 11 12

2018 11 8

Spinraza

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

ES/1/17/1188

2018 11 12

2018 11 8

Tracleer

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/02/220

2018 11 12

2018 11 8

Xeljanz

Pfizer Europe MA EEIG

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

ES/1/17/1178

2018 11 12

2018 11 12

Bemfola

Gedeon Richter Plc.

Gyömrői út 19–21., 1103 Budapest, Magyarország

ES/1/13/909

2018 11 14

2018 11 12

CABOMETYX

Ipsen Pharma

65 quai Georges Gorse, 92100 Boulogne-Billancourt, France

ES/1/16/1136

2018 11 14

2018 11 12

Clopidogrel ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/14/975

2018 11 14

2018 11 12

Desloratadine ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

ES/1/11/746

2018 11 14

2018 11 12

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/15/1051

2018 11 14

2018 11 12

Edistride

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/15/1052

2018 11 14

2018 11 12

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

ES/1/14/983

2018 11 14

2018 11 12

Forxiga

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/12/795

2018 11 14

2018 11 12

Jinarc

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292, 1101 CT, Amsterdam, Nederland

ES/1/15/1000

2018 11 14

2018 11 12

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/14/899

2018 11 14

2018 11 12

Olanzapinas Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

ES/1/08/475

2018 12 7

2018 11 12

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/13/900

2018 11 14

2018 11 14

Benlysta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/11/700

2018 11 16

2018 11 14

Daptomycin Hospira

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom

ES/1/17/1175

2018 11 16

2018 11 14

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/14/922

2018 11 16

2018 11 14

Izba

Novartis Europharm Limited

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

ES/1/13/905

2018 11 16

2018 11 14

Latuda

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

Viale Amelia 70, 00181 Roma, Italia

ES/1/14/913

2018 11 16

2018 11 14

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/14/899

2018 11 16

2018 11 14

Tecfidera

Biogen Idec Limited

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

ES/1/13/837

2018 11 16

2018 11 20

Brineura

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

ES/1/17/1192

2018 11 22

2018 11 20

Brintellix

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

ES/1/13/891

2018 11 22

2018 11 20

Emtricitabine/Tenofovir disoproxil Krka

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

ES/1/16/1151

2018 11 22

2018 11 20

Fluenz Tetra

AstraZeneca AB

151 85 Södertälje, Sverige

ES/1/13/887

2018 11 22

2018 11 20

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/14/922

2018 11 22

2018 11 20

Levetiracetam Hospira

Pfizer Europe MA EEIG

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

ES/1/13/889

2018 11 22

2018 11 20

Neuraceq

Life Radiopharma Berlin GmbH

Max-Planck-Straße 4, 12489 Berlin, Deutschland

ES/1/13/906

2018 11 22

2018 11 20

NovoSeven

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

ES/1/96/006

2018 11 22

2018 11 20

Orfadin

Swedish Orphan Biovitrum International AB

112 76 Stockholm, Sverige

ES/1/04/303

2018 11 23

2018 11 20

Ozurdex

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

ES/1/10/638

2018 11 22

2018 11 20

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/06/380

2018 11 22

2018 11 20

Rapiscan

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

ES/1/10/643

2018 11 22

2018 11 20

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/14/967

2018 11 22

2018 11 20

Selincro

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

ES/1/12/815

2018 11 22

2018 11 20

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

ES/1/17/1225

2018 11 22

2018 11 20

Zoledronic acid Accord

Accord Healthcare Limited

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

ES/1/13/834

2018 11 22

2018 11 22

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

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

ES/1/07/430

2018 11 26

2018 11 22

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

ES/1/12/812

2018 11 26

2018 11 22

Docetaxel Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

ES/1/07/384

2018 11 26

2018 11 22

Efient

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

ES/1/08/503

2018 11 26

2018 11 22

Erivedge

Roche Registration GmbH

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

ES/1/13/848

2018 11 26

2018 11 22

GILENYA

Novartis Europharm Limited

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

ES/1/11/677

2018 11 28

2018 11 22

Inlyta

Pfizer Europe MA EEIG

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

ES/1/12/777

2018 11 26

2018 11 22

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, 1030 Wien, Österreich

ES/1/08/501

2018 11 26

2018 11 22

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

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

ES/1/12/782

2018 11 26

2018 11 22

Kentera

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

ES/1/03/270

2018 11 26

2018 11 22

Kyprolis

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

ES/1/15/1060

2018 11 26

2018 11 22

Levetiracetam Hospira

Pfizer Europe MA EEIG

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

ES/1/13/889

2018 11 26

2018 11 22

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

ES/1/13/904

2018 11 26

2018 11 22

Nyxoid

Mundipharma Corporation (Ireland) Limited

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

ES/1/17/1238

2018 11 26

2018 11 22

Ranexa

Menarini International Operations Luxembourg S.A.

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

ES/1/08/462

2018 11 26

2018 11 22

Soliris

Alexion Europe SAS

1–15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

ES/1/07/393

2018 11 27

2018 11 22

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

ES/1/09/508

2018 11 26

2018 11 22

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

ES/1/14/982

2018 11 26

2018 11 22

Wakix

Bioprojet Pharma

9 rue Rameau, 75002 Paris, France

ES/1/15/1068

2018 11 26

2018 11 22

Zinforo

Pfizer Ireland Pharmaceuticals

Operations Support Group, Ringaskiddy, County Cork, Ireland

ES/1/12/785

2018 11 26

2018 11 26

alli

GlaxoSmithKline Dungarvan Limited

Knockbrack, Dungarvan, Co. Waterford, Ireland

ES/1/07/401

2018 11 29

2018 11 26

Anoro Ellipta

Glaxo Group Ltd

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

ES/1/14/898

2018 11 28

2018 11 26

Darunavir Krka d.d.

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

ES/1/17/1248

2018 11 28

2018 11 26

Docetaxel Zentiva

Zentiva k.s.

U kabelovny 130, 102 37 Praha 10, Česká republika

ES/1/07/384

2018 11 28

2018 11 26

Kalydeco

Vertex Pharmaceuticals (Ireland) Limited

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

ES/1/12/782

2018 11 28

2018 11 26

Leflunomide ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

ES/1/10/654

2018 11 28

2018 11 26

Orkambi

Vertex Pharmaceuticals (Ireland) Limited

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

ES/1/15/1059

2018 11 28

2018 11 26

PHEBURANE

Eurocept International BV

Trapgans 5, 1244 RL Ankeveen, Nederland

ES/1/13/822

2018 11 28

2018 11 26

Zeffix

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ES/1/99/114

2018 11 28

2018 11 28

AMGEVITA

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

ES/1/16/1164

2018 11 30

2018 11 28

Pregabalin Zentiva k.s

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

ES/1/16/1166

2018 11 30

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

—

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

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2018 11 12 | Eperzan | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | ES/1/13/908 | 2018 11 14 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 11 12

Eperzan

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

ES/1/13/908

2018 11 14

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

—

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

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2018 11 19 | Osurnia | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | ES/2/14/170 | 2018 11 21 |
| 2018 11 19 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | ES/2/07/078 | 2018 11 21 |
| 2018 11 26 | Econor | Elanco GmbH
  Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland | ES/2/98/010 | 2018 11 28 |
| 2018 11 26 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | ES/2/11/134 | 2018 11 29 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 11 19

Osurnia

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

ES/2/14/170

2018 11 21

2018 11 19

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

ES/2/07/078

2018 11 21

2018 11 26

Econor

Elanco GmbH

Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland

ES/2/98/010

2018 11 28

2018 11 26

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

ES/2/11/134

2018 11 29

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

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

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