# Europos Sąjungos C 309/2018

| | ISSN 1977-0960 |
| --- | --- |
| Europos Sąjungos
  oficialusis leidinys | C 309 |
| | |
| Leidimas lietuvių kalba | Informacija ir pranešimai | 61 metai2018m. rugpjūčio 31d. |

ISSN 1977-0960

Europos Sąjungos

oficialusis leidinys

C 309

Leidimas lietuvių kalba

Informacija ir pranešimai

61 metai2018m. rugpjūčio 31d.

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| Turinys | Puslapis |
| --- | --- |
| | IV   Pranešimai |
| | EUROPOS SĄJUNGOS INSTITUCIJŲ, ĮSTAIGŲ IR ORGANŲ PRANEŠIMAI |
| | Europos Komisija |
| 2018/C 309/01 | Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. liepos 1 d. iki 2018 m. liepos 31 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 309/01

Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. liepos 1 d. iki 2018 m. liepos 31 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

| 31.8.2018 | LT | Europos Sąjungos oficialusis leidinys | C 309/1 |
| --- | --- | --- | --- |

31.8.2018

LT

Europos Sąjungos oficialusis leidinys

C 309/1

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Europos Sąjungos sprendimų dėl vaistų rinkodaros leidimų santrauka nuo 2018 m. liepos 1 d. iki 2018 m. liepos 31 d.

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

(2018/C 309/01)

| — | 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 7 6 | Tegsedi | inoterseno | IONIS USA Limited
  Tower 42, Level 30, International Finance Centre, 25 Old Broad Street, EC2N 1HQ London, United Kingdom | EU/1/18/1296 | Injekcinis tirpalas | Pending | 2018 7 10 |
| 2018 7 6 | Verkazia | Ciklosporinas | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | EU/1/17/1219 | Akių lašai (emulsija) | S01XA18 | 2018 7 10 |
| 2018 7 26 | Aimovig | erenumabas | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1293 | Injekcinis tirpalas | N02C | 2018 7 30 |
| 2018 7 26 | Halimatoz | adalimumabas | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1288 | Injekcinis tirpalas | L04AB04 | 2018 7 30 |
| 2018 7 26 | Hefiya | adalimumabas | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1287 | Injekcinis tirpalas | L04AB04 | 2018 7 30 |
| 2018 7 26 | Hyrimoz | adalimumabas | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1286 | Injekcinis tirpalas | L04AB04 | 2018 7 30 |
| 2018 7 26 | Nityr | nitizinonas | Cycle Pharmaceuticals Ltd
  Bailey Grundy Barrett Building, Little St Mary’s Lane, CB2 1RR, Cambridge, United Kingdom | EU/1/18/1290 | Tabletės | A16AX04 | 2018 7 30 |
| 2018 7 26 | RXULTI | brexpiprazolum | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/18/1294 | Plėvele dengta tabletė | N05AX16 | 2018 7 30 |
| 2018 7 26 | Trazimera | trastuzumabas | Pfizer Europe MA EEIG
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/18/1295 | Milteliai koncentratui infuziniam tirpalui | L01XC03 | 2018 7 30 |
| 2018 7 30 | Myalepta | metreleptinas | Aegerion Pharmaceuticals B.V.
  Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland | EU/1/18/1276 | Milteliai injekciniam tirpalui | A16AA07 | 2018 8 1 |

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 7 6

Tegsedi

inoterseno

IONIS USA Limited

Tower 42, Level 30, International Finance Centre, 25 Old Broad Street, EC2N 1HQ London, United Kingdom

EU/1/18/1296

Injekcinis tirpalas

Pending

2018 7 10

2018 7 6

Verkazia

Ciklosporinas

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/17/1219

Akių lašai (emulsija)

S01XA18

2018 7 10

2018 7 26

Aimovig

erenumabas

Novartis Europharm Limited

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

EU/1/18/1293

Injekcinis tirpalas

N02C

2018 7 30

2018 7 26

Halimatoz

adalimumabas

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1288

Injekcinis tirpalas

L04AB04

2018 7 30

2018 7 26

Hefiya

adalimumabas

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

Injekcinis tirpalas

L04AB04

2018 7 30

2018 7 26

Hyrimoz

adalimumabas

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1286

Injekcinis tirpalas

L04AB04

2018 7 30

2018 7 26

Nityr

nitizinonas

Cycle Pharmaceuticals Ltd

Bailey Grundy Barrett Building, Little St Mary’s Lane, CB2 1RR, Cambridge, United Kingdom

EU/1/18/1290

Tabletės

A16AX04

2018 7 30

2018 7 26

RXULTI

brexpiprazolum

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/18/1294

Plėvele dengta tabletė

N05AX16

2018 7 30

2018 7 26

Trazimera

trastuzumabas

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/18/1295

Milteliai koncentratui infuziniam tirpalui

L01XC03

2018 7 30

2018 7 30

Myalepta

metreleptinas

Aegerion Pharmaceuticals B.V.

Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland

EU/1/18/1276

Milteliai injekciniam tirpalui

A16AA07

2018 8 1

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

—

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

| Sprendimo data | Vaisto pavadinimas | Rinkodaros leidimo turėtojas | Įrašo numeris Bendrijos vaistų registre | Pranešimo data |
| --- | --- | --- | --- | --- |
| 2018 7 17 | Aplidin | Pharma Mar S.A.
  Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España | — | 2018 7 19 |
| 2018 7 26 | Alsitek | AB Science
  3 avenue George V, 75008 Paris, France | — | 2018 7 30 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 7 17

Aplidin

Pharma Mar S.A.

Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España

—

2018 7 19

2018 7 26

Alsitek

AB Science

3 avenue George V, 75008 Paris, France

—

2018 7 30

| — | 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 7 2 | Bavencio | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/17/1214 | 2018 7 4 |
| 2018 7 2 | CONTROLOC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/515 | 2018 7 4 |
| 2018 7 2 | DepoCyte | Pacira Limited
  Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom | EU/1/01/187 | 2018 7 4 |
| 2018 7 2 | Docetaxel Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/769 | 2018 7 4 |
| 2018 7 2 | Enurev Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/789 | 2018 7 4 |
| 2018 7 2 | Ifirmacombi | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/673 | 2018 7 4 |
| 2018 7 2 | Lemtrada | Genzyme Therapeutics Ltd
  4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | EU/1/13/869 | 2018 7 4 |
| 2018 7 2 | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 2018 7 4 |
| 2018 7 2 | PANTOZOL Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/517 | 2018 7 4 |
| 2018 7 2 | Prialt | RIEMSER Pharma GmbH
  An der Wiek 7, 17493 Greifswald-Insel Riems, Deutschland | EU/1/04/302 | 2018 7 4 |
| 2018 7 2 | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546 | 2018 7 4 |
| 2018 7 2 | SOMAC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/516 | 2018 7 4 |
| 2018 7 2 | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363 | 2018 7 4 |
| 2018 7 2 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 2018 7 4 |
| 2018 7 2 | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/956 | 2018 7 3 |
| 2018 7 2 | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 2018 7 4 |
| 2018 7 6 | Adrovance | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/06/364 | 2018 7 10 |
| 2018 7 6 | ALPROLIX | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/16/1098 | 2018 7 10 |
| 2018 7 6 | Ammonaps | Swedish Orphan Biovitrum International AB
  112 76 Stockholm, Sverige | EU/1/99/120 | 2018 7 10 |
| 2018 7 6 | Ariclaim | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/283 | 2018 7 10 |
| 2018 7 6 | Corbilta | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/13/859 | 2018 7 10 |
| 2018 7 6 | Fertavid | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/09/510 | 2018 7 10 |
| 2018 7 6 | Hirobriz Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/594 | 2018 7 10 |
| 2018 7 6 | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 2018 7 10 |
| 2018 7 6 | Ninlaro | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/16/1094 | 2018 7 10 |
| 2018 7 6 | Noxafil | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/05/320 | 2018 7 10 |
| 2018 7 6 | Pemetrexed Fresenius Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/16/1115 | 2018 7 10 |
| 2018 7 6 | Pemetrexed Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1037 | 2018 7 10 |
| 2018 7 6 | Praxbind | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1056 | 2018 7 10 |
| 2018 7 6 | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/06/380 | 2018 7 10 |
| 2018 7 6 | Puregon | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/96/008 | 2018 7 10 |
| 2018 7 6 | Revolade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/612 | 2018 7 10 |
| 2018 7 6 | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/894 | 2018 7 10 |
| 2018 7 6 | Symtuza | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1225 | 2018 7 10 |
| 2018 7 6 | Tafinlar | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/865 | 2018 7 10 |
| 2018 7 6 | Temozolomide HEXAL | Hexal AG
  Industriestraße 25, 83607 Holzkirchen, Deutschland | EU/1/10/616 | 2018 7 10 |
| 2018 7 6 | Temozolomide Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/10/617 | 2018 7 10 |
| 2018 7 6 | Visudyne | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/00/140 | 2018 7 10 |
| 2018 7 6 | Zykadia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/999 | 2018 7 10 |
| 2018 7 9 | Betaferon | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/95/003 | 2018 7 11 |
| 2018 7 9 | Fosavance | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/05/310 | 2018 7 11 |
| 2018 7 9 | MAVENCLAD | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/17/1212 | 2018 7 11 |
| 2018 7 9 | Pylobactell | Torbet Laboratories Limited
  Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB, United Kingdom | EU/1/98/064 | 2018 7 11 |
| 2018 7 9 | Qutenza | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/09/524 | 2018 7 11 |
| 2018 7 9 | Seebri Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/788 | 2018 7 11 |
| 2018 7 9 | Tovanor Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/790 | 2018 7 11 |
| 2018 7 9 | Vantavo | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/09/572 | 2018 7 11 |
| 2018 7 9 | Zavesca | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/238 | 2018 7 11 |
| 2018 7 11 | Briviact | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/15/1073 | 2018 7 13 |
| 2018 7 11 | Byetta | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/06/362 | 2018 7 13 |
| 2018 7 11 | Erelzi | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/17/1195 | 2018 7 13 |
| 2018 7 11 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 2018 7 13 |
| 2018 7 11 | Vizamyl | GE Healthcare Ltd
  Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom | EU/1/14/941 | 2018 7 13 |
| 2018 7 11 | Xagrid | Shire Pharmaceutical Contracts Limited
  1 Kingdom Street, London W2 6BD, United Kingdom | EU/1/04/295 | 2018 7 13 |
| 2018 7 13 | Firdapse | BioMarin Europe Ltd
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/09/601 | 2018 7 17 |
| 2018 7 13 | Karvea | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/97/049 | 2018 7 17 |
| 2018 7 13 | Naglazyme | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork P43 R298, Ireland | EU/1/05/324 | 2018 7 17 |
| 2018 7 13 | Rebif | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063 | 2018 7 17 |
| 2018 7 19 | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/11/733 | 2018 7 23 |
| 2018 7 19 | Irbesartan Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/06/376 | 2018 7 23 |
| 2018 7 19 | Lopinavir/Ritonavir Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1067 | 2018 7 23 |
| 2018 7 19 | Optruma | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/98/074 | 2018 7 23 |
| 2018 7 19 | PecFent | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/10/644 | 2018 7 23 |
| 2018 7 19 | Plegridy | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/14/934 | 2018 7 23 |
| 2018 7 19 | Qarziba | EUSA Pharma (UK) Limited
  Breakspear Park, Breakspear Way, Hemel Hempstead HP2 4TZ, United Kingdom | EU/1/17/1191 | 2018 7 23 |
| 2018 7 19 | Rituzena | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1206 | 2018 7 23 |
| 2018 7 19 | SANCUSO | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/12/766 | 2018 7 23 |
| 2018 7 19 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 2018 7 23 |
| 2018 7 23 | Bemfola | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/13/909 | 2018 7 25 |
| 2018 7 23 | Eperzan | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/13/908 | 2018 7 25 |
| 2018 7 23 | Exjade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/356 | 2018 7 25 |
| 2018 7 23 | Ivemend | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/437 | 2018 7 25 |
| 2018 7 23 | Moventig | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/14/962 | 2018 7 25 |
| 2018 7 23 | Parsabiv | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1142 | 2018 7 25 |
| 2018 7 23 | PREVYMIS | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/17/1245 | 2018 7 25 |
| 2018 7 23 | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 2018 7 25 |
| 2018 7 23 | Ultibro Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/862 | 2018 7 25 |
| 2018 7 23 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 2018 7 25 |
| 2018 7 23 | Viread | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/01/200 | 2018 7 25 |
| 2018 7 23 | Xoterna Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/863 | 2018 7 25 |
| 2018 7 26 | Besponsa | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/17/1200 | 2018 7 30 |
| 2018 7 26 | Ceplene | Noventia Pharma Srl
  Via Carlo Pisacane 31, 47121 Forli, Italia | EU/1/08/477 | 2018 7 30 |
| 2018 7 26 | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/12/750 | 2018 7 30 |
| 2018 7 26 | Fareston | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/96/004 | 2018 7 30 |
| 2018 7 26 | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 2018 7 30 |
| 2018 7 26 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/13/884 | 2018 7 30 |
| 2018 7 26 | Jinarc | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | 2018 7 30 |
| 2018 7 26 | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/15/993 | 2018 7 30 |
| 2018 7 26 | NovoEight | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/13/888 | 2018 7 30 |
| 2018 7 26 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 2018 7 30 |
| 2018 7 26 | Procysbi | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/13/861 | 2018 7 30 |
| 2018 7 26 | Rasagiline ratiopharm | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/977 | 2018 7 30 |
| 2018 7 26 | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/13/886 | 2018 7 30 |
| 2018 7 26 | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/929 | 2018 7 30 |
| 2018 7 26 | Segluromet | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1265 | 2018 7 30 |
| 2018 7 26 | Trisenox | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/02/204 | 2018 7 30 |
| 2018 7 26 | Tybost | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/872 | 2018 7 30 |
| 2018 7 26 | Zalmoxis | MolMed S.p.A.
  Via Olgettina 58, 20132 Milano, Italia | EU/1/16/1121 | 2018 7 30 |
| 2018 7 30 | Abraxane | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/07/428 | 2018 8 1 |
| 2018 7 30 | Aprovel | Sanofi Clir SNC
  54 rue La Boétie, 75008 Paris, France | EU/1/97/046 | 2018 8 1 |
| 2018 7 30 | Arzerra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/625 | 2018 8 1 |
| 2018 7 30 | Bridion | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/466 | 2018 8 1 |
| 2018 7 30 | Champix | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/06/360 | 2018 8 1 |
| 2018 7 30 | Cyanokit | SERB S.A.
  Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België | EU/1/07/420 | 2018 8 1 |
| 2018 7 30 | Enbrel | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/99/126 | 2018 8 1 |
| 2018 7 30 | Eylea | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/12/797 | 2018 8 1 |
| 2018 7 30 | Grastofil | Apotex Europe B.V.
  Archimedesweg 2, 2333 CN Leiden, Nederland | EU/1/13/877 | 2018 8 1 |
| 2018 7 30 | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/11/678 | 2018 8 1 |
| 2018 7 30 | IBRANCE | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/16/1147 | 2018 8 1 |
| 2018 7 30 | Ilaris | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/564 | 2018 8 1 |
| 2018 7 30 | Imlygic | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1064 | 2018 8 1 |
| 2018 7 30 | Inflectra | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/13/854 | 2018 8 1 |
| 2018 7 30 | Intelence | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/468 | 2018 8 1 |
| 2018 7 30 | Lyrica | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/04/279 | 2018 8 1 |
| 2018 7 30 | Mylotarg | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/18/1277 | 2018 8 1 |
| 2018 7 30 | Nimenrix | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/12/767 | 2018 8 1 |
| 2018 7 30 | NovoEight | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/13/888 | 2018 8 1 |
| 2018 7 30 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 2018 8 1 |
| 2018 7 30 | Pregabalin Pfizer | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/14/916 | 2018 8 1 |
| 2018 7 30 | Revatio | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/05/318 | 2018 8 1 |
| 2018 7 30 | Stocrin | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/99/111 | 2018 8 1 |
| 2018 7 30 | Strimvelis | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/16/1097 | 2018 8 1 |
| 2018 7 30 | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/11/697 | 2018 8 1 |
| 2018 7 30 | Temozolomide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/606 | 2018 8 1 |
| 2018 7 30 | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/443 | 2018 8 1 |
| 2018 7 30 | Toviaz | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/07/386 | 2018 8 1 |
| 2018 7 30 | Tygacil | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/06/336 | 2018 8 1 |
| 2018 7 30 | Tyverb | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/440 | 2018 8 1 |
| 2018 7 30 | Ucedane | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/17/1202 | 2018 8 1 |
| 2018 7 30 | Viagra | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/98/077 | 2018 8 1 |
| 2018 7 30 | Vidaza | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/08/488 | 2018 8 1 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 7 2

Bavencio

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

2018 7 4

2018 7 2

CONTROLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/515

2018 7 4

2018 7 2

DepoCyte

Pacira Limited

Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom

EU/1/01/187

2018 7 4

2018 7 2

Docetaxel Accord

Accord Healthcare Limited

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

EU/1/12/769

2018 7 4

2018 7 2

Enurev Breezhaler

Novartis Europharm Limited

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

EU/1/12/789

2018 7 4

2018 7 2

Ifirmacombi

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/673

2018 7 4

2018 7 2

Lemtrada

Genzyme Therapeutics Ltd

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom

EU/1/13/869

2018 7 4

2018 7 2

Mysimba

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/14/988

2018 7 4

2018 7 2

PANTOZOL Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/517

2018 7 4

2018 7 2

Prialt

RIEMSER Pharma GmbH

An der Wiek 7, 17493 Greifswald-Insel Riems, Deutschland

EU/1/04/302

2018 7 4

2018 7 2

Simponi

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546

2018 7 4

2018 7 2

SOMAC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/516

2018 7 4

2018 7 2

Sprycel

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/363

2018 7 4

2018 7 2

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

2018 7 4

2018 7 2

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

2018 7 3

2018 7 2

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

2018 7 4

2018 7 6

Adrovance

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/364

2018 7 10

2018 7 6

ALPROLIX

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/16/1098

2018 7 10

2018 7 6

Ammonaps

Swedish Orphan Biovitrum International AB

112 76 Stockholm, Sverige

EU/1/99/120

2018 7 10

2018 7 6

Ariclaim

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/283

2018 7 10

2018 7 6

Corbilta

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/13/859

2018 7 10

2018 7 6

Fertavid

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/09/510

2018 7 10

2018 7 6

Hirobriz Breezhaler

Novartis Europharm Limited

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

EU/1/09/594

2018 7 10

2018 7 6

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

2018 7 10

2018 7 6

Ninlaro

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/16/1094

2018 7 10

2018 7 6

Noxafil

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/320

2018 7 10

2018 7 6

Pemetrexed Fresenius Kabi

Fresenius Kabi Deutschland GmbH

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

EU/1/16/1115

2018 7 10

2018 7 6

Pemetrexed Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1037

2018 7 10

2018 7 6

Praxbind

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1056

2018 7 10

2018 7 6

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/06/380

2018 7 10

2018 7 6

Puregon

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/96/008

2018 7 10

2018 7 6

Revolade

Novartis Europharm Limited

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

EU/1/10/612

2018 7 10

2018 7 6

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/894

2018 7 10

2018 7 6

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

2018 7 10

2018 7 6

Tafinlar

Novartis Europharm Limited

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

EU/1/13/865

2018 7 10

2018 7 6

Temozolomide HEXAL

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/10/616

2018 7 10

2018 7 6

Temozolomide Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/10/617

2018 7 10

2018 7 6

Visudyne

Novartis Europharm Limited

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

EU/1/00/140

2018 7 10

2018 7 6

Zykadia

Novartis Europharm Limited

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

EU/1/15/999

2018 7 10

2018 7 9

Betaferon

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/95/003

2018 7 11

2018 7 9

Fosavance

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/310

2018 7 11

2018 7 9

MAVENCLAD

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1212

2018 7 11

2018 7 9

Pylobactell

Torbet Laboratories Limited

Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB, United Kingdom

EU/1/98/064

2018 7 11

2018 7 9

Qutenza

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/09/524

2018 7 11

2018 7 9

Seebri Breezhaler

Novartis Europharm Limited

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

EU/1/12/788

2018 7 11

2018 7 9

Tovanor Breezhaler

Novartis Europharm Limited

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

EU/1/12/790

2018 7 11

2018 7 9

Vantavo

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/09/572

2018 7 11

2018 7 9

Zavesca

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/238

2018 7 11

2018 7 11

Briviact

UCB Pharma S.A.

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

EU/1/15/1073

2018 7 13

2018 7 11

Byetta

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/06/362

2018 7 13

2018 7 11

Erelzi

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

2018 7 13

2018 7 11

Imnovid

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/13/850

2018 7 13

2018 7 11

Vizamyl

GE Healthcare Ltd

Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom

EU/1/14/941

2018 7 13

2018 7 11

Xagrid

Shire Pharmaceutical Contracts Limited

1 Kingdom Street, London W2 6BD, United Kingdom

EU/1/04/295

2018 7 13

2018 7 13

Firdapse

BioMarin Europe Ltd

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/09/601

2018 7 17

2018 7 13

Karvea

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/97/049

2018 7 17

2018 7 13

Naglazyme

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

2018 7 17

2018 7 13

Rebif

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/98/063

2018 7 17

2018 7 19

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/11/733

2018 7 23

2018 7 19

Irbesartan Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/06/376

2018 7 23

2018 7 19

Lopinavir/Ritonavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1067

2018 7 23

2018 7 19

Optruma

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/98/074

2018 7 23

2018 7 19

PecFent

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/10/644

2018 7 23

2018 7 19

Plegridy

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/14/934

2018 7 23

2018 7 19

Qarziba

EUSA Pharma (UK) Limited

Breakspear Park, Breakspear Way, Hemel Hempstead HP2 4TZ, United Kingdom

EU/1/17/1191

2018 7 23

2018 7 19

Rituzena

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/17/1206

2018 7 23

2018 7 19

SANCUSO

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/12/766

2018 7 23

2018 7 19

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

2018 7 23

2018 7 23

Bemfola

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/13/909

2018 7 25

2018 7 23

Eperzan

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/13/908

2018 7 25

2018 7 23

Exjade

Novartis Europharm Limited

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

EU/1/06/356

2018 7 25

2018 7 23

Ivemend

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/437

2018 7 25

2018 7 23

Moventig

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/14/962

2018 7 25

2018 7 23

Parsabiv

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1142

2018 7 25

2018 7 23

PREVYMIS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

2018 7 25

2018 7 23

Translarna

PTC Therapeutics International Limited

5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland

EU/1/13/902

2018 7 25

2018 7 23

Ultibro Breezhaler

Novartis Europharm Limited

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

EU/1/13/862

2018 7 25

2018 7 23

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

2018 7 25

2018 7 23

Viread

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/01/200

2018 7 25

2018 7 23

Xoterna Breezhaler

Novartis Europharm Limited

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

EU/1/13/863

2018 7 25

2018 7 26

Besponsa

Pfizer Europe MA EEIG

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

EU/1/17/1200

2018 7 30

2018 7 26

Ceplene

Noventia Pharma Srl

Via Carlo Pisacane 31, 47121 Forli, Italia

EU/1/08/477

2018 7 30

2018 7 26

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750

2018 7 30

2018 7 26

Fareston

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/96/004

2018 7 30

2018 7 26

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

2018 7 30

2018 7 26

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/884

2018 7 30

2018 7 26

Jinarc

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/15/1000

2018 7 30

2018 7 26

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

2018 7 30

2018 7 26

NovoEight

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/13/888

2018 7 30

2018 7 26

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

2018 7 30

2018 7 26

Procysbi

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/13/861

2018 7 30

2018 7 26

Rasagiline ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/977

2018 7 30

2018 7 26

Relvar Ellipta

Glaxo Group Ltd

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

EU/1/13/886

2018 7 30

2018 7 26

Revinty Ellipta

Glaxo Group Ltd

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

EU/1/14/929

2018 7 30

2018 7 26

Segluromet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1265

2018 7 30

2018 7 26

Trisenox

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/02/204

2018 7 30

2018 7 26

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

2018 7 30

2018 7 26

Zalmoxis

MolMed S.p.A.

Via Olgettina 58, 20132 Milano, Italia

EU/1/16/1121

2018 7 30

2018 7 30

Abraxane

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/428

2018 8 1

2018 7 30

Aprovel

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/97/046

2018 8 1

2018 7 30

Arzerra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/625

2018 8 1

2018 7 30

Bridion

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/466

2018 8 1

2018 7 30

Champix

Pfizer Europe MA EEIG

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

EU/1/06/360

2018 8 1

2018 7 30

Cyanokit

SERB S.A.

Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België

EU/1/07/420

2018 8 1

2018 7 30

Enbrel

Pfizer Europe MA EEIG

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

EU/1/99/126

2018 8 1

2018 7 30

Eylea

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

2018 8 1

2018 7 30

Grastofil

Apotex Europe B.V.

Archimedesweg 2, 2333 CN Leiden, Nederland

EU/1/13/877

2018 8 1

2018 7 30

HALAVEN

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom

EU/1/11/678

2018 8 1

2018 7 30

IBRANCE

Pfizer Europe MA EEIG

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

EU/1/16/1147

2018 8 1

2018 7 30

Ilaris

Novartis Europharm Limited

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

EU/1/09/564

2018 8 1

2018 7 30

Imlygic

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1064

2018 8 1

2018 7 30

Inflectra

Pfizer Europe MA EEIG

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

EU/1/13/854

2018 8 1

2018 7 30

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/468

2018 8 1

2018 7 30

Lyrica

Pfizer Europe MA EEIG

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

EU/1/04/279

2018 8 1

2018 7 30

Mylotarg

Pfizer Europe MA EEIG

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

EU/1/18/1277

2018 8 1

2018 7 30

Nimenrix

Pfizer Europe MA EEIG

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

EU/1/12/767

2018 8 1

2018 7 30

NovoEight

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/13/888

2018 8 1

2018 7 30

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

2018 8 1

2018 7 30

Pregabalin Pfizer

Pfizer Europe MA EEIG

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

EU/1/14/916

2018 8 1

2018 7 30

Revatio

Pfizer Europe MA EEIG

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

EU/1/05/318

2018 8 1

2018 7 30

Stocrin

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

2018 8 1

2018 7 30

Strimvelis

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/16/1097

2018 8 1

2018 7 30

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/697

2018 8 1

2018 7 30

Temozolomide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/606

2018 8 1

2018 7 30

Thalidomide Celgene

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/08/443

2018 8 1

2018 7 30

Toviaz

Pfizer Europe MA EEIG

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

EU/1/07/386

2018 8 1

2018 7 30

Tygacil

Pfizer Europe MA EEIG

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

EU/1/06/336

2018 8 1

2018 7 30

Tyverb

Novartis Europharm Limited

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

EU/1/07/440

2018 8 1

2018 7 30

Ucedane

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/17/1202

2018 8 1

2018 7 30

Viagra

Pfizer Europe MA EEIG

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

EU/1/98/077

2018 8 1

2018 7 30

Vidaza

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/488

2018 8 1

| — | 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 7 6 | DepoCyte | Pacira Limited
  Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom | EU/1/01/187 | 2018 7 10 |
| 2018 7 9 | Ariclaim | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/283 | 2018 7 11 |
| 2018 7 19 | Trobalt | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/11/681 | 2018 7 23 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 7 6

DepoCyte

Pacira Limited

Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom

EU/1/01/187

2018 7 10

2018 7 9

Ariclaim

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/283

2018 7 11

2018 7 19

Trobalt

Glaxo Group Ltd

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

EU/1/11/681

2018 7 23

| — | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2018 7 26 | UBAC | Streptococcus uberis vakcina (inaktyvinta) | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/18/227 | Injekcinė emulsija | QI02AB | 2018 7 30 |

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 7 26

UBAC

Streptococcus uberis vakcina (inaktyvinta)

Laboratorios Hipra, S.A.

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

EU/2/18/227

Injekcinė emulsija

QI02AB

2018 7 30

| — | 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 7 2 | ERYSENG PARVO | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/14/167 | 2018 7 4 |
| 2018 7 2 | Zolvix | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/09/101 | 2018 7 4 |
| 2018 7 5 | Pexion | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/147 | 2018 7 9 |
| 2018 7 9 | Coliprotec F4/F18 | Prevtec Microbia GmbH
  Geyerspergerstr 27, 80689 München, Deutschland | EU/2/16/202 | 2018 7 11 |
| 2018 7 9 | Credelio | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/17/206 | 2018 7 11 |
| 2018 7 9 | ERYSENG | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/14/166 | 2018 7 11 |
| 2018 7 9 | Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/10/114 | 2018 7 11 |
| 2018 7 9 | Trocoxil | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/08/084 | 2018 7 11 |
| 2018 7 10 | Econor | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/98/010 | 2018 7 12 |
| 2018 7 12 | Procox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/11/123 | 2018 7 16 |
| 2018 7 13 | Reconcile | Nexcyon Pharmaceuticals Ltd
  First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom | EU/2/08/080 | 2018 7 16 |
| 2018 7 23 | Nobivac L4 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/12/143 | 2018 7 25 |
| 2018 7 23 | Respiporc Flu3 | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/09/103 | 2018 7 25 |
| 2018 7 26 | Apoquel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/13/154 | 2018 7 30 |

Sprendimo data

Vaisto pavadinimas

Rinkodaros leidimo turėtojas

Įrašo numeris Bendrijos vaistų registre

Pranešimo data

2018 7 2

ERYSENG PARVO

Laboratorios Hipra, S.A.

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

EU/2/14/167

2018 7 4

2018 7 2

Zolvix

Elanco Europe Ltd

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/09/101

2018 7 4

2018 7 5

Pexion

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/147

2018 7 9

2018 7 9

Coliprotec F4/F18

Prevtec Microbia GmbH

Geyerspergerstr 27, 80689 München, Deutschland

EU/2/16/202

2018 7 11

2018 7 9

Credelio

Elanco Europe Ltd

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/17/206

2018 7 11

2018 7 9

ERYSENG

Laboratorios Hipra, S.A.

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

EU/2/14/166

2018 7 11

2018 7 9

Hiprabovis IBR Marker Live

Laboratorios Hipra, S.A.

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

EU/2/10/114

2018 7 11

2018 7 9

Trocoxil

Zoetis Belgium S.A.

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

EU/2/08/084

2018 7 11

2018 7 10

Econor

Elanco Europe Ltd

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/98/010

2018 7 12

2018 7 12

Procox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/11/123

2018 7 16

2018 7 13

Reconcile

Nexcyon Pharmaceuticals Ltd

First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom

EU/2/08/080

2018 7 16

2018 7 23

Nobivac L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/12/143

2018 7 25

2018 7 23

Respiporc Flu3

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/09/103

2018 7 25

2018 7 26

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

2018 7 30

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

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

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