# Eiropas Savienības C 309/2018

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 309 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 61. gadagājums2018. gada 31. augusts |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 309

Izdevums latviešu valodā

Informācija un paziņojumi

61. gadagājums2018. gada 31. augusts

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| Saturs | Lappuse |
| --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2018/C 309/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. jūlija līdz 2018. gada 31. jūlijam(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu) | 1 |

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2018/C 309/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. jūlija līdz 2018. gada 31. jūlijam(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)

(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu)

1

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| LV | |
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LV

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IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

| 31.8.2018 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 309/1 |
| --- | --- | --- | --- |

31.8.2018

LV

Eiropas Savienības Oficiālais Vēstnesis

C 309/1

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2018. gada 1. jūlija līdz 2018. gada 31. jūlijam

(Publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 (1) 13. vai 38. pantu)

(2018/C 309/01)

| — | Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas |
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Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.7.2018. | Tegsedi | inotersena | IONIS USA Limited
  Tower 42, Level 30, International Finance Centre, 25 Old Broad Street, EC2N 1HQ London, United Kingdom | EU/1/18/1296 | Šķīdums injekcijai | Pending | 10.7.2018. |
| 6.7.2018. | Verkazia | Ciklosporīns | Santen Oy
  Niittyhaankatu 20, 33720 Tampere, Suomi | EU/1/17/1219 | Acu pilieni, emulsija | S01XA18 | 10.7.2018. |
| 26.7.2018. | Aimovig | erenumabs | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/18/1293 | Šķīdums injekcijai | N02C | 30.7.2018. |
| 26.7.2018. | Halimatoz | adalimumabs | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1288 | Šķīdums injekcijai | L04AB04 | 30.7.2018. |
| 26.7.2018. | Hefiya | adalimumabs | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1287 | Šķīdums injekcijai | L04AB04 | 30.7.2018. |
| 26.7.2018. | Hyrimoz | adalimumabs | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1286 | Šķīdums injekcijai | L04AB04 | 30.7.2018. |
| 26.7.2018. | Nityr | nitizinons | Cycle Pharmaceuticals Ltd
  Bailey Grundy Barrett Building, Little St Mary’s Lane, CB2 1RR, Cambridge, United Kingdom | EU/1/18/1290 | Tabletes | A16AX04 | 30.7.2018. |
| 26.7.2018. | RXULTI | brexpiprazolum | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/18/1294 | Apvalkotās tabletes | N05AX16 | 30.7.2018. |
| 26.7.2018. | Trazimera | trastuzumabs | Pfizer Europe MA EEIG
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/18/1295 | Pulveris infūziju šķīduma koncentrāta pagatavošanai | L01XC03 | 30.7.2018. |
| 30.7.2018. | Myalepta | metreleptin | Aegerion Pharmaceuticals B.V.
  Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland | EU/1/18/1276 | Pulveris injekciju šķīduma pagatavošanai | A16AA07 | 1.8.2018. |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

6.7.2018.

Tegsedi

inotersena

IONIS USA Limited

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

EU/1/18/1296

Šķīdums injekcijai

Pending

10.7.2018.

6.7.2018.

Verkazia

Ciklosporīns

Santen Oy

Niittyhaankatu 20, 33720 Tampere, Suomi

EU/1/17/1219

Acu pilieni, emulsija

S01XA18

10.7.2018.

26.7.2018.

Aimovig

erenumabs

Novartis Europharm Limited

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

EU/1/18/1293

Šķīdums injekcijai

N02C

30.7.2018.

26.7.2018.

Halimatoz

adalimumabs

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1288

Šķīdums injekcijai

L04AB04

30.7.2018.

26.7.2018.

Hefiya

adalimumabs

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1287

Šķīdums injekcijai

L04AB04

30.7.2018.

26.7.2018.

Hyrimoz

adalimumabs

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1286

Šķīdums injekcijai

L04AB04

30.7.2018.

26.7.2018.

Nityr

nitizinons

Cycle Pharmaceuticals Ltd

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

EU/1/18/1290

Tabletes

A16AX04

30.7.2018.

26.7.2018.

RXULTI

brexpiprazolum

Otsuka Pharmaceutical Europe Ltd

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

EU/1/18/1294

Apvalkotās tabletes

N05AX16

30.7.2018.

26.7.2018.

Trazimera

trastuzumabs

Pfizer Europe MA EEIG

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

EU/1/18/1295

Pulveris infūziju šķīduma koncentrāta pagatavošanai

L01XC03

30.7.2018.

30.7.2018.

Myalepta

metreleptin

Aegerion Pharmaceuticals B.V.

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

EU/1/18/1276

Pulveris injekciju šķīduma pagatavošanai

A16AA07

1.8.2018.

| — | Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): noraidītas |
| --- | --- |

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Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): noraidītas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 17.7.2018. | Aplidin | Pharma Mar S.A.
  Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España | — | 19.7.2018. |
| 26.7.2018. | Alsitek | AB Science
  3 avenue George V, 75008 Paris, France | — | 30.7.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

17.7.2018.

Aplidin

Pharma Mar S.A.

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

—

19.7.2018.

26.7.2018.

Alsitek

AB Science

3 avenue George V, 75008 Paris, France

—

30.7.2018.

| — | Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas |
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Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 2.7.2018. | Bavencio | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/17/1214 | 4.7.2018. |
| 2.7.2018. | CONTROLOC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/515 | 4.7.2018. |
| 2.7.2018. | DepoCyte | Pacira Limited
  Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom | EU/1/01/187 | 4.7.2018. |
| 2.7.2018. | Docetaxel Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/769 | 4.7.2018. |
| 2.7.2018. | Enurev Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/789 | 4.7.2018. |
| 2.7.2018. | Ifirmacombi | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/673 | 4.7.2018. |
| 2.7.2018. | Lemtrada | Genzyme Therapeutics Ltd
  4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | EU/1/13/869 | 4.7.2018. |
| 2.7.2018. | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 4.7.2018. |
| 2.7.2018. | PANTOZOL Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/517 | 4.7.2018. |
| 2.7.2018. | Prialt | RIEMSER Pharma GmbH
  An der Wiek 7, 17493 Greifswald-Insel Riems, Deutschland | EU/1/04/302 | 4.7.2018. |
| 2.7.2018. | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546 | 4.7.2018. |
| 2.7.2018. | SOMAC Control | Takeda GmbH
  Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland | EU/1/09/516 | 4.7.2018. |
| 2.7.2018. | Sprycel | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363 | 4.7.2018. |
| 2.7.2018. | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 4.7.2018. |
| 2.7.2018. | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/956 | 3.7.2018. |
| 2.7.2018. | Xarelto | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/08/472 | 4.7.2018. |
| 6.7.2018. | Adrovance | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/06/364 | 10.7.2018. |
| 6.7.2018. | ALPROLIX | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/16/1098 | 10.7.2018. |
| 6.7.2018. | Ammonaps | Swedish Orphan Biovitrum International AB
  112 76 Stockholm, Sverige | EU/1/99/120 | 10.7.2018. |
| 6.7.2018. | Ariclaim | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/283 | 10.7.2018. |
| 6.7.2018. | Corbilta | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/13/859 | 10.7.2018. |
| 6.7.2018. | Fertavid | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/09/510 | 10.7.2018. |
| 6.7.2018. | Hirobriz Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/594 | 10.7.2018. |
| 6.7.2018. | KEYTRUDA | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/1024 | 10.7.2018. |
| 6.7.2018. | Ninlaro | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/16/1094 | 10.7.2018. |
| 6.7.2018. | Noxafil | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/05/320 | 10.7.2018. |
| 6.7.2018. | Pemetrexed Fresenius Kabi | Fresenius Kabi Deutschland GmbH
  Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland | EU/1/16/1115 | 10.7.2018. |
| 6.7.2018. | Pemetrexed Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/15/1037 | 10.7.2018. |
| 6.7.2018. | Praxbind | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/15/1056 | 10.7.2018. |
| 6.7.2018. | PREZISTA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/06/380 | 10.7.2018. |
| 6.7.2018. | Puregon | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/96/008 | 10.7.2018. |
| 6.7.2018. | Revolade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/10/612 | 10.7.2018. |
| 6.7.2018. | Sovaldi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/894 | 10.7.2018. |
| 6.7.2018. | Symtuza | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/17/1225 | 10.7.2018. |
| 6.7.2018. | Tafinlar | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/865 | 10.7.2018. |
| 6.7.2018. | Temozolomide HEXAL | Hexal AG
  Industriestraße 25, 83607 Holzkirchen, Deutschland | EU/1/10/616 | 10.7.2018. |
| 6.7.2018. | Temozolomide Sandoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/10/617 | 10.7.2018. |
| 6.7.2018. | Visudyne | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/00/140 | 10.7.2018. |
| 6.7.2018. | Zykadia | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/15/999 | 10.7.2018. |
| 9.7.2018. | Betaferon | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/95/003 | 11.7.2018. |
| 9.7.2018. | Fosavance | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/05/310 | 11.7.2018. |
| 9.7.2018. | MAVENCLAD | Merck Europe B.V.
  Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland | EU/1/17/1212 | 11.7.2018. |
| 9.7.2018. | Pylobactell | Torbet Laboratories Limited
  Unit 1 Chestnut Drive, Wymondham, Norfolk, NR18 9SB, United Kingdom | EU/1/98/064 | 11.7.2018. |
| 9.7.2018. | Qutenza | Grünenthal GmbH
  Zieglerstraße 6, 52078, Aachen, Deutschland | EU/1/09/524 | 11.7.2018. |
| 9.7.2018. | Seebri Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/788 | 11.7.2018. |
| 9.7.2018. | Tovanor Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/12/790 | 11.7.2018. |
| 9.7.2018. | Vantavo | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/09/572 | 11.7.2018. |
| 9.7.2018. | Zavesca | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/238 | 11.7.2018. |
| 11.7.2018. | Briviact | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/15/1073 | 13.7.2018. |
| 11.7.2018. | Byetta | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/06/362 | 13.7.2018. |
| 11.7.2018. | Erelzi | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/17/1195 | 13.7.2018. |
| 11.7.2018. | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 13.7.2018. |
| 11.7.2018. | Vizamyl | GE Healthcare Ltd
  Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom | EU/1/14/941 | 13.7.2018. |
| 11.7.2018. | Xagrid | Shire Pharmaceutical Contracts Limited
  1 Kingdom Street, London W2 6BD, United Kingdom | EU/1/04/295 | 13.7.2018. |
| 13.7.2018. | Firdapse | BioMarin Europe Ltd
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/09/601 | 17.7.2018. |
| 13.7.2018. | Karvea | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/97/049 | 17.7.2018. |
| 13.7.2018. | Naglazyme | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork P43 R298, Ireland | EU/1/05/324 | 17.7.2018. |
| 13.7.2018. | Rebif | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063 | 17.7.2018. |
| 19.7.2018. | Dificlir | Astellas Pharma Europe B.V.
  Sylviusweg 62, 2333 BE Leiden, Nederland | EU/1/11/733 | 23.7.2018. |
| 19.7.2018. | Irbesartan Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/06/376 | 23.7.2018. |
| 19.7.2018. | Lopinavir/Ritonavir Mylan | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/15/1067 | 23.7.2018. |
| 19.7.2018. | Optruma | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/98/074 | 23.7.2018. |
| 19.7.2018. | PecFent | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/10/644 | 23.7.2018. |
| 19.7.2018. | Plegridy | Biogen Netherlands B.V.
  Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland | EU/1/14/934 | 23.7.2018. |
| 19.7.2018. | Qarziba | EUSA Pharma (UK) Limited
  Breakspear Park, Breakspear Way, Hemel Hempstead HP2 4TZ, United Kingdom | EU/1/17/1191 | 23.7.2018. |
| 19.7.2018. | Rituzena | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/17/1206 | 23.7.2018. |
| 19.7.2018. | SANCUSO | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/12/766 | 23.7.2018. |
| 19.7.2018. | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 23.7.2018. |
| 23.7.2018. | Bemfola | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/13/909 | 25.7.2018. |
| 23.7.2018. | Eperzan | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/13/908 | 25.7.2018. |
| 23.7.2018. | Exjade | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/356 | 25.7.2018. |
| 23.7.2018. | Ivemend | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/07/437 | 25.7.2018. |
| 23.7.2018. | Moventig | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/14/962 | 25.7.2018. |
| 23.7.2018. | Parsabiv | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1142 | 25.7.2018. |
| 23.7.2018. | PREVYMIS | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/17/1245 | 25.7.2018. |
| 23.7.2018. | Translarna | PTC Therapeutics International Limited
  5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland | EU/1/13/902 | 25.7.2018. |
| 23.7.2018. | Ultibro Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/862 | 25.7.2018. |
| 23.7.2018. | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 25.7.2018. |
| 23.7.2018. | Viread | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/01/200 | 25.7.2018. |
| 23.7.2018. | Xoterna Breezhaler | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/13/863 | 25.7.2018. |
| 26.7.2018. | Besponsa | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/17/1200 | 30.7.2018. |
| 26.7.2018. | Ceplene | Noventia Pharma Srl
  Via Carlo Pisacane 31, 47121 Forli, Italia | EU/1/08/477 | 30.7.2018. |
| 26.7.2018. | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/12/750 | 30.7.2018. |
| 26.7.2018. | Fareston | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/96/004 | 30.7.2018. |
| 26.7.2018. | Genvoya | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/15/1061 | 30.7.2018. |
| 26.7.2018. | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/13/884 | 30.7.2018. |
| 26.7.2018. | Jinarc | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | 30.7.2018. |
| 26.7.2018. | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/15/993 | 30.7.2018. |
| 26.7.2018. | NovoEight | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/13/888 | 30.7.2018. |
| 26.7.2018. | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 30.7.2018. |
| 26.7.2018. | Procysbi | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/13/861 | 30.7.2018. |
| 26.7.2018. | Rasagiline ratiopharm | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/977 | 30.7.2018. |
| 26.7.2018. | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/13/886 | 30.7.2018. |
| 26.7.2018. | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/929 | 30.7.2018. |
| 26.7.2018. | Segluromet | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/18/1265 | 30.7.2018. |
| 26.7.2018. | Trisenox | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/02/204 | 30.7.2018. |
| 26.7.2018. | Tybost | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/13/872 | 30.7.2018. |
| 26.7.2018. | Zalmoxis | MolMed S.p.A.
  Via Olgettina 58, 20132 Milano, Italia | EU/1/16/1121 | 30.7.2018. |
| 30.7.2018. | Abraxane | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/07/428 | 1.8.2018. |
| 30.7.2018. | Aprovel | Sanofi Clir SNC
  54 rue La Boétie, 75008 Paris, France | EU/1/97/046 | 1.8.2018. |
| 30.7.2018. | Arzerra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/625 | 1.8.2018. |
| 30.7.2018. | Bridion | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/08/466 | 1.8.2018. |
| 30.7.2018. | Champix | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/06/360 | 1.8.2018. |
| 30.7.2018. | Cyanokit | SERB S.A.
  Avenue Louise 480, 1050 Bruxelles, Belgique / Louizalaan 480, 1050 Brussel, België | EU/1/07/420 | 1.8.2018. |
| 30.7.2018. | Enbrel | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/99/126 | 1.8.2018. |
| 30.7.2018. | Eylea | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/12/797 | 1.8.2018. |
| 30.7.2018. | Grastofil | Apotex Europe B.V.
  Archimedesweg 2, 2333 CN Leiden, Nederland | EU/1/13/877 | 1.8.2018. |
| 30.7.2018. | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/11/678 | 1.8.2018. |
| 30.7.2018. | IBRANCE | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/16/1147 | 1.8.2018. |
| 30.7.2018. | Ilaris | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/09/564 | 1.8.2018. |
| 30.7.2018. | Imlygic | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/15/1064 | 1.8.2018. |
| 30.7.2018. | Inflectra | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/13/854 | 1.8.2018. |
| 30.7.2018. | Intelence | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/468 | 1.8.2018. |
| 30.7.2018. | Lyrica | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/04/279 | 1.8.2018. |
| 30.7.2018. | Mylotarg | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/18/1277 | 1.8.2018. |
| 30.7.2018. | Nimenrix | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/12/767 | 1.8.2018. |
| 30.7.2018. | NovoEight | Novo Nordisk A/S
  Novo Allé, 2880 Bagsværd, Danmark | EU/1/13/888 | 1.8.2018. |
| 30.7.2018. | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 1.8.2018. |
| 30.7.2018. | Pregabalin Pfizer | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/14/916 | 1.8.2018. |
| 30.7.2018. | Revatio | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/05/318 | 1.8.2018. |
| 30.7.2018. | Stocrin | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/99/111 | 1.8.2018. |
| 30.7.2018. | Strimvelis | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/16/1097 | 1.8.2018. |
| 30.7.2018. | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/11/697 | 1.8.2018. |
| 30.7.2018. | Temozolomide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/606 | 1.8.2018. |
| 30.7.2018. | Thalidomide Celgene | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/08/443 | 1.8.2018. |
| 30.7.2018. | Toviaz | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/07/386 | 1.8.2018. |
| 30.7.2018. | Tygacil | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/06/336 | 1.8.2018. |
| 30.7.2018. | Tyverb | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/440 | 1.8.2018. |
| 30.7.2018. | Ucedane | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/17/1202 | 1.8.2018. |
| 30.7.2018. | Viagra | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/98/077 | 1.8.2018. |
| 30.7.2018. | Vidaza | Celgene Europe B.V.
  Winthontlaan 6 N, 3526 KV Utrecht, Nederland | EU/1/08/488 | 1.8.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

2.7.2018.

Bavencio

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1214

4.7.2018.

2.7.2018.

CONTROLOC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/515

4.7.2018.

2.7.2018.

DepoCyte

Pacira Limited

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

EU/1/01/187

4.7.2018.

2.7.2018.

Docetaxel Accord

Accord Healthcare Limited

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

EU/1/12/769

4.7.2018.

2.7.2018.

Enurev Breezhaler

Novartis Europharm Limited

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

EU/1/12/789

4.7.2018.

2.7.2018.

Ifirmacombi

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/673

4.7.2018.

2.7.2018.

Lemtrada

Genzyme Therapeutics Ltd

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

EU/1/13/869

4.7.2018.

2.7.2018.

Mysimba

Orexigen Therapeutics Ireland Limited

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

EU/1/14/988

4.7.2018.

2.7.2018.

PANTOZOL Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/517

4.7.2018.

2.7.2018.

Prialt

RIEMSER Pharma GmbH

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

EU/1/04/302

4.7.2018.

2.7.2018.

Simponi

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546

4.7.2018.

2.7.2018.

SOMAC Control

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland

EU/1/09/516

4.7.2018.

2.7.2018.

Sprycel

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/363

4.7.2018.

2.7.2018.

Tecentriq

Roche Registration GmbH

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

EU/1/17/1220

4.7.2018.

2.7.2018.

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

3.7.2018.

2.7.2018.

Xarelto

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/08/472

4.7.2018.

6.7.2018.

Adrovance

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/06/364

10.7.2018.

6.7.2018.

ALPROLIX

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/16/1098

10.7.2018.

6.7.2018.

Ammonaps

Swedish Orphan Biovitrum International AB

112 76 Stockholm, Sverige

EU/1/99/120

10.7.2018.

6.7.2018.

Ariclaim

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/283

10.7.2018.

6.7.2018.

Corbilta

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/13/859

10.7.2018.

6.7.2018.

Fertavid

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/09/510

10.7.2018.

6.7.2018.

Hirobriz Breezhaler

Novartis Europharm Limited

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

EU/1/09/594

10.7.2018.

6.7.2018.

KEYTRUDA

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/1024

10.7.2018.

6.7.2018.

Ninlaro

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/16/1094

10.7.2018.

6.7.2018.

Noxafil

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/320

10.7.2018.

6.7.2018.

Pemetrexed Fresenius Kabi

Fresenius Kabi Deutschland GmbH

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

EU/1/16/1115

10.7.2018.

6.7.2018.

Pemetrexed Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/15/1037

10.7.2018.

6.7.2018.

Praxbind

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/15/1056

10.7.2018.

6.7.2018.

PREZISTA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/06/380

10.7.2018.

6.7.2018.

Puregon

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/96/008

10.7.2018.

6.7.2018.

Revolade

Novartis Europharm Limited

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

EU/1/10/612

10.7.2018.

6.7.2018.

Sovaldi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/894

10.7.2018.

6.7.2018.

Symtuza

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/17/1225

10.7.2018.

6.7.2018.

Tafinlar

Novartis Europharm Limited

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

EU/1/13/865

10.7.2018.

6.7.2018.

Temozolomide HEXAL

Hexal AG

Industriestraße 25, 83607 Holzkirchen, Deutschland

EU/1/10/616

10.7.2018.

6.7.2018.

Temozolomide Sandoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/10/617

10.7.2018.

6.7.2018.

Visudyne

Novartis Europharm Limited

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

EU/1/00/140

10.7.2018.

6.7.2018.

Zykadia

Novartis Europharm Limited

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

EU/1/15/999

10.7.2018.

9.7.2018.

Betaferon

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/95/003

11.7.2018.

9.7.2018.

Fosavance

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/05/310

11.7.2018.

9.7.2018.

MAVENCLAD

Merck Europe B.V.

Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland

EU/1/17/1212

11.7.2018.

9.7.2018.

Pylobactell

Torbet Laboratories Limited

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

EU/1/98/064

11.7.2018.

9.7.2018.

Qutenza

Grünenthal GmbH

Zieglerstraße 6, 52078, Aachen, Deutschland

EU/1/09/524

11.7.2018.

9.7.2018.

Seebri Breezhaler

Novartis Europharm Limited

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

EU/1/12/788

11.7.2018.

9.7.2018.

Tovanor Breezhaler

Novartis Europharm Limited

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

EU/1/12/790

11.7.2018.

9.7.2018.

Vantavo

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/09/572

11.7.2018.

9.7.2018.

Zavesca

Actelion Registration Ltd

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

EU/1/02/238

11.7.2018.

11.7.2018.

Briviact

UCB Pharma S.A.

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

EU/1/15/1073

13.7.2018.

11.7.2018.

Byetta

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/06/362

13.7.2018.

11.7.2018.

Erelzi

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1195

13.7.2018.

11.7.2018.

Imnovid

Celgene Europe Limited

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

EU/1/13/850

13.7.2018.

11.7.2018.

Vizamyl

GE Healthcare Ltd

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

EU/1/14/941

13.7.2018.

11.7.2018.

Xagrid

Shire Pharmaceutical Contracts Limited

1 Kingdom Street, London W2 6BD, United Kingdom

EU/1/04/295

13.7.2018.

13.7.2018.

Firdapse

BioMarin Europe Ltd

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/09/601

17.7.2018.

13.7.2018.

Karvea

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/97/049

17.7.2018.

13.7.2018.

Naglazyme

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork P43 R298, Ireland

EU/1/05/324

17.7.2018.

13.7.2018.

Rebif

Merck Serono Europe Limited

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

EU/1/98/063

17.7.2018.

19.7.2018.

Dificlir

Astellas Pharma Europe B.V.

Sylviusweg 62, 2333 BE Leiden, Nederland

EU/1/11/733

23.7.2018.

19.7.2018.

Irbesartan Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/06/376

23.7.2018.

19.7.2018.

Lopinavir/Ritonavir Mylan

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/15/1067

23.7.2018.

19.7.2018.

Optruma

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/98/074

23.7.2018.

19.7.2018.

PecFent

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/10/644

23.7.2018.

19.7.2018.

Plegridy

Biogen Netherlands B.V.

Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland

EU/1/14/934

23.7.2018.

19.7.2018.

Qarziba

EUSA Pharma (UK) Limited

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

EU/1/17/1191

23.7.2018.

19.7.2018.

Rituzena

Celltrion Healthcare Hungary Kft.

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

EU/1/17/1206

23.7.2018.

19.7.2018.

SANCUSO

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/12/766

23.7.2018.

19.7.2018.

Translarna

PTC Therapeutics International Limited

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

EU/1/13/902

23.7.2018.

23.7.2018.

Bemfola

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/13/909

25.7.2018.

23.7.2018.

Eperzan

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/13/908

25.7.2018.

23.7.2018.

Exjade

Novartis Europharm Limited

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

EU/1/06/356

25.7.2018.

23.7.2018.

Ivemend

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/07/437

25.7.2018.

23.7.2018.

Moventig

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/14/962

25.7.2018.

23.7.2018.

Parsabiv

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1142

25.7.2018.

23.7.2018.

PREVYMIS

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/17/1245

25.7.2018.

23.7.2018.

Translarna

PTC Therapeutics International Limited

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

EU/1/13/902

25.7.2018.

23.7.2018.

Ultibro Breezhaler

Novartis Europharm Limited

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

EU/1/13/862

25.7.2018.

23.7.2018.

Vargatef

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/954

25.7.2018.

23.7.2018.

Viread

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/01/200

25.7.2018.

23.7.2018.

Xoterna Breezhaler

Novartis Europharm Limited

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

EU/1/13/863

25.7.2018.

26.7.2018.

Besponsa

Pfizer Europe MA EEIG

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

EU/1/17/1200

30.7.2018.

26.7.2018.

Ceplene

Noventia Pharma Srl

Via Carlo Pisacane 31, 47121 Forli, Italia

EU/1/08/477

30.7.2018.

26.7.2018.

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750

30.7.2018.

26.7.2018.

Fareston

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/96/004

30.7.2018.

26.7.2018.

Genvoya

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/15/1061

30.7.2018.

26.7.2018.

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/13/884

30.7.2018.

26.7.2018.

Jinarc

Otsuka Pharmaceutical Europe Ltd

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

EU/1/15/1000

30.7.2018.

26.7.2018.

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/15/993

30.7.2018.

26.7.2018.

NovoEight

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/13/888

30.7.2018.

26.7.2018.

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

30.7.2018.

26.7.2018.

Procysbi

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/13/861

30.7.2018.

26.7.2018.

Rasagiline ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/977

30.7.2018.

26.7.2018.

Relvar Ellipta

Glaxo Group Ltd

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

EU/1/13/886

30.7.2018.

26.7.2018.

Revinty Ellipta

Glaxo Group Ltd

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

EU/1/14/929

30.7.2018.

26.7.2018.

Segluromet

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/18/1265

30.7.2018.

26.7.2018.

Trisenox

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/02/204

30.7.2018.

26.7.2018.

Tybost

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/13/872

30.7.2018.

26.7.2018.

Zalmoxis

MolMed S.p.A.

Via Olgettina 58, 20132 Milano, Italia

EU/1/16/1121

30.7.2018.

30.7.2018.

Abraxane

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/07/428

1.8.2018.

30.7.2018.

Aprovel

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/97/046

1.8.2018.

30.7.2018.

Arzerra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/625

1.8.2018.

30.7.2018.

Bridion

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/08/466

1.8.2018.

30.7.2018.

Champix

Pfizer Europe MA EEIG

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

EU/1/06/360

1.8.2018.

30.7.2018.

Cyanokit

SERB S.A.

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

EU/1/07/420

1.8.2018.

30.7.2018.

Enbrel

Pfizer Europe MA EEIG

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

EU/1/99/126

1.8.2018.

30.7.2018.

Eylea

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/12/797

1.8.2018.

30.7.2018.

Grastofil

Apotex Europe B.V.

Archimedesweg 2, 2333 CN Leiden, Nederland

EU/1/13/877

1.8.2018.

30.7.2018.

HALAVEN

Eisai Europe Limited

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

EU/1/11/678

1.8.2018.

30.7.2018.

IBRANCE

Pfizer Europe MA EEIG

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

EU/1/16/1147

1.8.2018.

30.7.2018.

Ilaris

Novartis Europharm Limited

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

EU/1/09/564

1.8.2018.

30.7.2018.

Imlygic

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/15/1064

1.8.2018.

30.7.2018.

Inflectra

Pfizer Europe MA EEIG

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

EU/1/13/854

1.8.2018.

30.7.2018.

Intelence

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/468

1.8.2018.

30.7.2018.

Lyrica

Pfizer Europe MA EEIG

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

EU/1/04/279

1.8.2018.

30.7.2018.

Mylotarg

Pfizer Europe MA EEIG

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

EU/1/18/1277

1.8.2018.

30.7.2018.

Nimenrix

Pfizer Europe MA EEIG

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

EU/1/12/767

1.8.2018.

30.7.2018.

NovoEight

Novo Nordisk A/S

Novo Allé, 2880 Bagsværd, Danmark

EU/1/13/888

1.8.2018.

30.7.2018.

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

1.8.2018.

30.7.2018.

Pregabalin Pfizer

Pfizer Europe MA EEIG

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

EU/1/14/916

1.8.2018.

30.7.2018.

Revatio

Pfizer Europe MA EEIG

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

EU/1/05/318

1.8.2018.

30.7.2018.

Stocrin

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/99/111

1.8.2018.

30.7.2018.

Strimvelis

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/16/1097

1.8.2018.

30.7.2018.

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/697

1.8.2018.

30.7.2018.

Temozolomide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/606

1.8.2018.

30.7.2018.

Thalidomide Celgene

Celgene Europe Limited

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

EU/1/08/443

1.8.2018.

30.7.2018.

Toviaz

Pfizer Europe MA EEIG

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

EU/1/07/386

1.8.2018.

30.7.2018.

Tygacil

Pfizer Europe MA EEIG

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

EU/1/06/336

1.8.2018.

30.7.2018.

Tyverb

Novartis Europharm Limited

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

EU/1/07/440

1.8.2018.

30.7.2018.

Ucedane

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/17/1202

1.8.2018.

30.7.2018.

Viagra

Pfizer Europe MA EEIG

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

EU/1/98/077

1.8.2018.

30.7.2018.

Vidaza

Celgene Europe B.V.

Winthontlaan 6 N, 3526 KV Utrecht, Nederland

EU/1/08/488

1.8.2018.

| — | Tirdzniecības atļaujas izņemšana no aprites (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants) |
| --- | --- |

—

Tirdzniecības atļaujas izņemšana no aprites (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. pants)

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 6.7.2018. | DepoCyte | Pacira Limited
  Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom | EU/1/01/187 | 10.7.2018. |
| 9.7.2018. | Ariclaim | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/283 | 11.7.2018. |
| 19.7.2018. | Trobalt | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/11/681 | 23.7.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

6.7.2018.

DepoCyte

Pacira Limited

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

EU/1/01/187

10.7.2018.

9.7.2018.

Ariclaim

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/283

11.7.2018.

19.7.2018.

Trobalt

Glaxo Group Ltd

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

EU/1/11/681

23.7.2018.

| — | Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas |
| --- | --- |

—

Tirdzniecības atļaujas izsniegšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | INN (starptautiskais nepatentētais nosaukums) | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Farmaceitiskā forma | AĶT kods (Anatomiski ķīmiski terapeitiskais kods) | Paziņojuma datums |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 26.7.2018. | UBAC | Vakcīna (inaktivētas) pret Streptococcus uberis | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/18/227 | Emulsija injekcijai | QI02AB | 30.7.2018. |

Lēmuma datums

Zāļu nosaukums

INN (starptautiskais nepatentētais nosaukums)

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Farmaceitiskā forma

AĶT kods (Anatomiski ķīmiski terapeitiskais kods)

Paziņojuma datums

26.7.2018.

UBAC

Vakcīna (inaktivētas) pret Streptococcus uberis

Laboratorios Hipra, S.A.

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

EU/2/18/227

Emulsija injekcijai

QI02AB

30.7.2018.

| — | Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas |
| --- | --- |

—

Tirdzniecības atļaujas grozīšana (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants): pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 2.7.2018. | ERYSENG PARVO | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/14/167 | 4.7.2018. |
| 2.7.2018. | Zolvix | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/09/101 | 4.7.2018. |
| 5.7.2018. | Pexion | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/147 | 9.7.2018. |
| 9.7.2018. | Coliprotec F4/F18 | Prevtec Microbia GmbH
  Geyerspergerstr 27, 80689 München, Deutschland | EU/2/16/202 | 11.7.2018. |
| 9.7.2018. | Credelio | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/17/206 | 11.7.2018. |
| 9.7.2018. | ERYSENG | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/14/166 | 11.7.2018. |
| 9.7.2018. | Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, 17170 Amer (Girona), España | EU/2/10/114 | 11.7.2018. |
| 9.7.2018. | Trocoxil | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/08/084 | 11.7.2018. |
| 10.7.2018. | Econor | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/98/010 | 12.7.2018. |
| 12.7.2018. | Procox | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/11/123 | 16.7.2018. |
| 13.7.2018. | Reconcile | Nexcyon Pharmaceuticals Ltd
  First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom | EU/2/08/080 | 16.7.2018. |
| 23.7.2018. | Nobivac L4 | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/12/143 | 25.7.2018. |
| 23.7.2018. | Respiporc Flu3 | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/09/103 | 25.7.2018. |
| 26.7.2018. | Apoquel | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/13/154 | 30.7.2018. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

2.7.2018.

ERYSENG PARVO

Laboratorios Hipra, S.A.

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

EU/2/14/167

4.7.2018.

2.7.2018.

Zolvix

Elanco Europe Ltd

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

EU/2/09/101

4.7.2018.

5.7.2018.

Pexion

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/147

9.7.2018.

9.7.2018.

Coliprotec F4/F18

Prevtec Microbia GmbH

Geyerspergerstr 27, 80689 München, Deutschland

EU/2/16/202

11.7.2018.

9.7.2018.

Credelio

Elanco Europe Ltd

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

EU/2/17/206

11.7.2018.

9.7.2018.

ERYSENG

Laboratorios Hipra, S.A.

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

EU/2/14/166

11.7.2018.

9.7.2018.

Hiprabovis IBR Marker Live

Laboratorios Hipra, S.A.

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

EU/2/10/114

11.7.2018.

9.7.2018.

Trocoxil

Zoetis Belgium S.A.

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

EU/2/08/084

11.7.2018.

10.7.2018.

Econor

Elanco Europe Ltd

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

EU/2/98/010

12.7.2018.

12.7.2018.

Procox

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/11/123

16.7.2018.

13.7.2018.

Reconcile

Nexcyon Pharmaceuticals Ltd

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

EU/2/08/080

16.7.2018.

23.7.2018.

Nobivac L4

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/12/143

25.7.2018.

23.7.2018.

Respiporc Flu3

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/09/103

25.7.2018.

26.7.2018.

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

30.7.2018.

Ikvienam, kurš vēlas apskatīt publisko novērtējuma ziņojumu par attiecīgajām zālēm un ar tām saistītos lēmumus, jāsazinās ar:

| 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)  OV L 136, 30.4.2004., 1. lpp.

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