# Eiropas Savienības C 61/2017

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 61 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 60. gadagājums2017. gada 24. februāris |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 61

Izdevums latviešu valodā

Informācija un paziņojumi

60. gadagājums2017. gada 24. februāris

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| Paziņojums Nr. | Saturs | Lappuse |
| --- | --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2017/C 61/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2017. gada 1. janvāra līdz 2017. gada 31. janvārim(Publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004) | 1 |

Paziņojums Nr.

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2017/C 61/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2017. gada 1. janvāra līdz 2017. gada 31. janvārim(Publicēts saskaņā ar 13. vai 38. pantu Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004)

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

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

| 24.2.2017 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 61/1 |
| --- | --- | --- | --- |

24.2.2017

LV

Eiropas Savienības Oficiālais Vēstnesis

C 61/1

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2017. gada 1. janvāra līdz 2017. gada 31. janvārim

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

(2017/C 061/01)

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

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Tirdzniecības atļaujas izsniegšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.1.2017. | AFSTYLA | lonoctocog alfa | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/16/1158 | Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | B02BD02 | 6.1.2017. |
| 4.1.2017. | Darunavir Mylan | darunavirum | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1140 | Apvalkotās tabletes | J05AE10 | 6.1.2017. |
| 4.1.2017. | Lusduna | Insulīns, glargīna | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/16/1162 | Šķīdums injekcijai | A10AE04 | 6.1.2017. |
| 4.1.2017. | Terrosa | teriparatide | Gedeon Richter Plc.
  Gyömrői út 19-21., H-1103 Budapest, Magyarország | EU/1/16/1159 | Šķīdums injekcijai | H05AA02 | 6.1.2017. |
| 9.1.2017. | Fiasp | Asparta insulīns | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsværd, Danmark | EU/1/16/1160 | Šķīdums injekcijai | A10AB05 | 11.1.2017. |
| 9.1.2017. | Tadalafil Generics | tadalafils | Mylan S.A.S.
  117 Allée des Parcs, 69800 Saint-Priest, France | EU/1/16/1153 | Apvalkotās tabletes | G04BE08 | 11.1.2017. |
| 9.1.2017. | Vemlidy | tenofovir alafenamide | Gilead Sciences International Ltd.
  Cambridge, CB21 6GT, United Kingdom | EU/1/16/1154 | Apvalkotās tabletes | J05AF13 | 11.1.2017. |
| 11.1.2017. | Movymia | teriparatide | STADA Arzneimittel AG
  Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland | EU/1/16/1161 | Šķīdums injekcijai | H05AA02 | 13.1.2017. |
| 11.1.2017. | Suliqua | glargīna insulīns/liksizenatīds | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/16/1157 | Šķīdums injekcijai | A10AE54 | 13.1.2017. |
| 18.1.2017. | ZINPLAVA | bezlotoksumabs | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/16/1156 | Koncentrāts infūziju šķīduma pagatavošanai | J06BB21 | 20.1.2017. |
| 19.1.2017. | Cystadrops | mercaptamine | Orphan Europe SARL
  Immeuble “Le Wilson”, 70, Avenue du Général de Gaulle, 92800 Puteaux, France | EU/1/15/1049 | Acu pilieni, šķīdums | S01XA21 | 23.1.2017. |

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

4.1.2017.

AFSTYLA

lonoctocog alfa

CSL Behring GmbH

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

EU/1/16/1158

Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

B02BD02

6.1.2017.

4.1.2017.

Darunavir Mylan

darunavirum

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/16/1140

Apvalkotās tabletes

J05AE10

6.1.2017.

4.1.2017.

Lusduna

Insulīns, glargīna

Merck Sharp & Dohme Limited

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

EU/1/16/1162

Šķīdums injekcijai

A10AE04

6.1.2017.

4.1.2017.

Terrosa

teriparatide

Gedeon Richter Plc.

Gyömrői út 19-21., H-1103 Budapest, Magyarország

EU/1/16/1159

Šķīdums injekcijai

H05AA02

6.1.2017.

9.1.2017.

Fiasp

Asparta insulīns

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsværd, Danmark

EU/1/16/1160

Šķīdums injekcijai

A10AB05

11.1.2017.

9.1.2017.

Tadalafil Generics

tadalafils

Mylan S.A.S.

117 Allée des Parcs, 69800 Saint-Priest, France

EU/1/16/1153

Apvalkotās tabletes

G04BE08

11.1.2017.

9.1.2017.

Vemlidy

tenofovir alafenamide

Gilead Sciences International Ltd.

Cambridge, CB21 6GT, United Kingdom

EU/1/16/1154

Apvalkotās tabletes

J05AF13

11.1.2017.

11.1.2017.

Movymia

teriparatide

STADA Arzneimittel AG

Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland

EU/1/16/1161

Šķīdums injekcijai

H05AA02

13.1.2017.

11.1.2017.

Suliqua

glargīna insulīns/liksizenatīds

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/16/1157

Šķīdums injekcijai

A10AE54

13.1.2017.

18.1.2017.

ZINPLAVA

bezlotoksumabs

Merck Sharp & Dohme Limited

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

EU/1/16/1156

Koncentrāts infūziju šķīduma pagatavošanai

J06BB21

20.1.2017.

19.1.2017.

Cystadrops

mercaptamine

Orphan Europe SARL

Immeuble “Le Wilson”, 70, Avenue du Général de Gaulle, 92800 Puteaux, France

EU/1/15/1049

Acu pilieni, šķīdums

S01XA21

23.1.2017.

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

—

Tirdzniecības atļaujas grozīšana (13. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): Pieņemtas

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 4.1.2017. | Emadine | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/98/095 | 6.1.2017. |
| 4.1.2017. | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 6.1.2017. |
| 4.1.2017. | Incruse | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/922 | 6.1.2017. |
| 4.1.2017. | Kolbam | Retrophin Europe Limited
  Palmerstown House, Fenian Street, Dublin 2, Ireland | EU/1/13/895 | 6.1.2017. |
| 4.1.2017. | Vepacel | Nanotherapeutics Bohumil, s.r.o.
  Bohumil 138, 28163 Jevany, Česká republika | EU/1/12/752 | 6.1.2017. |
| 4.1.2017. | Zonegran | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/04/307 | 6.1.2017. |
| 9.1.2017. | Capecitabine Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/762 | 11.1.2017. |
| 9.1.2017. | Capecitabine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 11.1.2017. |
| 9.1.2017. | DaTSCAN | GE Healthcare Limited
  Little Chalfont, Bucks HP7 9NA, United Kingdom | EU/1/00/135 | 11.1.2017. |
| 9.1.2017. | Foclivia | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/09/577 | 11.1.2017. |
| 9.1.2017. | Naglazyme | BioMarin Europe Ltd.
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/05/324 | 13.1.2017. |
| 9.1.2017. | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 11.1.2017. |
| 9.1.2017. | Relistor | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Česká republika | EU/1/08/463 | 11.1.2017. |
| 9.1.2017. | Riluzole Zentiva | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/12/768 | 11.1.2017. |
| 9.1.2017. | SANCUSO | Kyowa Kirin Limited
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/12/766 | 11.1.2017. |
| 9.1.2017. | Translarna | PTC Therapeutics International Limited
  77 Sir John Rogerson’s Quay, Dublin 2, Ireland | EU/1/13/902 | 11.1.2017. |
| 9.1.2017. | Viagra | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/98/077 | 11.1.2017. |
| 9.1.2017. | Viramune | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/055 | 11.1.2017. |
| 9.1.2017. | Xultophy | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsværd, Danmark | EU/1/14/947 | 11.1.2017. |
| 11.1.2017. | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/447 | 13.1.2017. |
| 11.1.2017. | Brintellix | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/13/891 | 13.1.2017. |
| 11.1.2017. | Bronchitol | Pharmaxis Pharmaceuticals Limited
  25 Moorgate, London, EC2R 6AY, United Kingdom. | EU/1/12/760 | 13.1.2017. |
| 11.1.2017. | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/13/890 | 13.1.2017. |
| 11.1.2017. | Defitelio | Gentium S.r.l
  Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia | EU/1/13/878 | 16.1.2017. |
| 11.1.2017. | Entresto | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1058 | 13.1.2017. |
| 11.1.2017. | Herceptin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/145 | 13.1.2017. |
| 11.1.2017. | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 13.1.2017. |
| 11.1.2017. | Inovelon | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/06/378 | 13.1.2017. |
| 11.1.2017. | Invanz | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/02/216 | 13.1.2017. |
| 11.1.2017. | Ivemend | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/437 | 13.1.2017. |
| 11.1.2017. | Kuvan | BioMarin International Limited
  Shanbally, Ringaskiddy, County Cork, Ireland | EU/1/08/481 | 13.1.2017. |
| 11.1.2017. | Pregabalin Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/997 | 13.1.2017. |
| 11.1.2017. | Pregabalin Mylan Pharma | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/998 | 13.1.2017. |
| 11.1.2017. | Ruconest | Pharming Group N.V.
  Darwinweg 24, NL-2333 CR Leiden, Nederland | EU/1/10/641 | 13.1.2017. |
| 11.1.2017. | Vimizim | BioMarin Europe Ltd.
  10 Bloomsbury Way, London WC1A 2SL, United Kingdom | EU/1/14/914 | 13.1.2017. |
| 11.1.2017. | Xadago | Zambon S.p.A.
  Via Lillo del Duca 10, 20 091 Bresso (MI), Italia | EU/1/14/984 | 13.1.2017. |
| 19.1.2017. | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 23.1.2017. |
| 23.1.2017. | Lymphoseek | Norgine B.V.
  Hogehilweg 7, 1101CA Amsterdam, Nederland | EU/1/14/955 | 25.1.2017. |
| 23.1.2017. | Remsima | Celltrion Healthcare Hungary Kft.
  Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország | EU/1/13/853 | 25.1.2017. |
| 26.1.2017. | Cinryze | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 30.1.2017. |
| 26.1.2017. | Iclusig | Incyte Biosciences UK Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 30.1.2017. |
| 26.1.2017. | NovoSeven | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsværd, Danmark | EU/1/96/006 | 30.1.2017. |
| 26.1.2017. | Orfadin | Swedish Orphan Biovitrum International AB
  SE-112 76 Stockholm, Sverige | EU/1/04/303 | 30.1.2017. |
| 26.1.2017. | Picato | LEO Laboratories Ltd.
  285 Cashel Road, Crumlin, Dublin 12, Ireland | EU/1/12/796 | 30.1.2017. |
| 26.1.2017. | Rezolsta | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/967 | 30.1.2017. |
| 26.1.2017. | Voriconazole Hikma | Hikma Farmacêutica (Portugal), S.A.
  Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal | EU/1/15/1004 | 30.1.2017. |
| 27.1.2017. | Ameluz | Biofrontera Bioscience GmbH
  Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland | EU/1/11/740 | 31.1.2017. |
| 27.1.2017. | Benepali | Samsung Bioepis UK Limited
  3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom | EU/1/15/1074 | 31.1.2017. |
| 27.1.2017. | Docetaxel Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/769 | 31.1.2017. |
| 27.1.2017. | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 31.1.2017. |
| 27.1.2017. | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 31.1.2017. |
| 27.1.2017. | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 31.1.2017. |
| 27.1.2017. | Stivarga | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/858 | 31.1.2017. |
| 27.1.2017. | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 31.1.2017. |
| 27.1.2017. | Vaxelis | MCM Vaccine B.V.
  Robert Boyleweg 4, 2333 CG Leiden, Nederland | EU/1/15/1079 | 31.1.2017. |
| 27.1.2017. | Votubia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | 31.1.2017. |
| 27.1.2017. | Xydalba | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/14/986 | 31.1.2017. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

4.1.2017.

Emadine

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/98/095

6.1.2017.

4.1.2017.

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

6.1.2017.

4.1.2017.

Incruse

Glaxo Group Ltd

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

EU/1/14/922

6.1.2017.

4.1.2017.

Kolbam

Retrophin Europe Limited

Palmerstown House, Fenian Street, Dublin 2, Ireland

EU/1/13/895

6.1.2017.

4.1.2017.

Vepacel

Nanotherapeutics Bohumil, s.r.o.

Bohumil 138, 28163 Jevany, Česká republika

EU/1/12/752

6.1.2017.

4.1.2017.

Zonegran

Eisai Limited

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

EU/1/04/307

6.1.2017.

9.1.2017.

Capecitabine Accord

Accord Healthcare Limited

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

EU/1/12/762

11.1.2017.

9.1.2017.

Capecitabine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

11.1.2017.

9.1.2017.

DaTSCAN

GE Healthcare Limited

Little Chalfont, Bucks HP7 9NA, United Kingdom

EU/1/00/135

11.1.2017.

9.1.2017.

Foclivia

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/09/577

11.1.2017.

9.1.2017.

Naglazyme

BioMarin Europe Ltd.

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/05/324

13.1.2017.

9.1.2017.

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

11.1.2017.

9.1.2017.

Relistor

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Česká republika

EU/1/08/463

11.1.2017.

9.1.2017.

Riluzole Zentiva

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony CEDEX, France

EU/1/12/768

11.1.2017.

9.1.2017.

SANCUSO

Kyowa Kirin Limited

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

EU/1/12/766

11.1.2017.

9.1.2017.

Translarna

PTC Therapeutics International Limited

77 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/13/902

11.1.2017.

9.1.2017.

Viagra

Pfizer Limited

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

EU/1/98/077

11.1.2017.

9.1.2017.

Viramune

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/055

11.1.2017.

9.1.2017.

Xultophy

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsværd, Danmark

EU/1/14/947

11.1.2017.

11.1.2017.

Adenuric

Menarini International Operations Luxembourg S.A.

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

EU/1/08/447

13.1.2017.

11.1.2017.

Brintellix

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/13/891

13.1.2017.

11.1.2017.

Bronchitol

Pharmaxis Pharmaceuticals Limited

25 Moorgate, London, EC2R 6AY, United Kingdom.

EU/1/12/760

13.1.2017.

11.1.2017.

Cometriq

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/13/890

13.1.2017.

11.1.2017.

Defitelio

Gentium S.r.l

Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia

EU/1/13/878

16.1.2017.

11.1.2017.

Entresto

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1058

13.1.2017.

11.1.2017.

Herceptin

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/00/145

13.1.2017.

11.1.2017.

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

13.1.2017.

11.1.2017.

Inovelon

Eisai Limited

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

EU/1/06/378

13.1.2017.

11.1.2017.

Invanz

Merck Sharp & Dohme Limited

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

EU/1/02/216

13.1.2017.

11.1.2017.

Ivemend

Merck Sharp & Dohme Limited

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

EU/1/07/437

13.1.2017.

11.1.2017.

Kuvan

BioMarin International Limited

Shanbally, Ringaskiddy, County Cork, Ireland

EU/1/08/481

13.1.2017.

11.1.2017.

Pregabalin Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/997

13.1.2017.

11.1.2017.

Pregabalin Mylan Pharma

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/998

13.1.2017.

11.1.2017.

Ruconest

Pharming Group N.V.

Darwinweg 24, NL-2333 CR Leiden, Nederland

EU/1/10/641

13.1.2017.

11.1.2017.

Vimizim

BioMarin Europe Ltd.

10 Bloomsbury Way, London WC1A 2SL, United Kingdom

EU/1/14/914

13.1.2017.

11.1.2017.

Xadago

Zambon S.p.A.

Via Lillo del Duca 10, 20 091 Bresso (MI), Italia

EU/1/14/984

13.1.2017.

19.1.2017.

Jardiance

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/14/930

23.1.2017.

23.1.2017.

Lymphoseek

Norgine B.V.

Hogehilweg 7, 1101CA Amsterdam, Nederland

EU/1/14/955

25.1.2017.

23.1.2017.

Remsima

Celltrion Healthcare Hungary Kft.

Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország

EU/1/13/853

25.1.2017.

26.1.2017.

Cinryze

Shire Services BVBA

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

EU/1/11/688

30.1.2017.

26.1.2017.

Iclusig

Incyte Biosciences UK Ltd

Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom

EU/1/13/839

30.1.2017.

26.1.2017.

NovoSeven

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsværd, Danmark

EU/1/96/006

30.1.2017.

26.1.2017.

Orfadin

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

EU/1/04/303

30.1.2017.

26.1.2017.

Picato

LEO Laboratories Ltd.

285 Cashel Road, Crumlin, Dublin 12, Ireland

EU/1/12/796

30.1.2017.

26.1.2017.

Rezolsta

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/967

30.1.2017.

26.1.2017.

Voriconazole Hikma

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal

EU/1/15/1004

30.1.2017.

27.1.2017.

Ameluz

Biofrontera Bioscience GmbH

Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland

EU/1/11/740

31.1.2017.

27.1.2017.

Benepali

Samsung Bioepis UK Limited

3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom

EU/1/15/1074

31.1.2017.

27.1.2017.

Docetaxel Accord

Accord Healthcare Limited

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

EU/1/12/769

31.1.2017.

27.1.2017.

Jentadueto

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/12/780

31.1.2017.

27.1.2017.

KEYTRUDA

Merck Sharp & Dohme Limited

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

EU/1/15/1024

31.1.2017.

27.1.2017.

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

31.1.2017.

27.1.2017.

Stivarga

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/858

31.1.2017.

27.1.2017.

Trajenta

Boehringer Ingelheim International GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/11/707

31.1.2017.

27.1.2017.

Vaxelis

MCM Vaccine B.V.

Robert Boyleweg 4, 2333 CG Leiden, Nederland

EU/1/15/1079

31.1.2017.

27.1.2017.

Votubia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

31.1.2017.

27.1.2017.

Xydalba

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/14/986

31.1.2017.

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

—

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

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 9.1.2017. | Vylaer Spiromax | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/949 | 11.1.2017. |
| 18.1.2017. | Clopidogrel Acino | Acino AG
  Am Windfeld 35, 83714 D-Miesbach, Deutschland | EU/1/09/532 | 20.1.2017. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

9.1.2017.

Vylaer Spiromax

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/949

11.1.2017.

18.1.2017.

Clopidogrel Acino

Acino AG

Am Windfeld 35, 83714 D-Miesbach, Deutschland

EU/1/09/532

20.1.2017.

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

—

Tirdzniecības atļaujas izsniegšana (38. pants Eiropas Parlamenta un Padomes Regulā (EK) Nr. 726/2004): 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.1.2017. | Coliprotec F4/F18 | Sivēnu pēcatšķiršanas diarejas vakcīna (dzīva) | Prevtec Microbia GmbH
  Geyerspergerstr 27, 80689 München, Deutschland | EU/2/16/202 | Liofilizāts iekšķīgi lietojamai suspensijai | QI09AE03 | 11.1.2017. |

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

9.1.2017.

Coliprotec F4/F18

Sivēnu pēcatšķiršanas diarejas vakcīna (dzīva)

Prevtec Microbia GmbH

Geyerspergerstr 27, 80689 München, Deutschland

EU/2/16/202

Liofilizāts iekšķīgi lietojamai suspensijai

QI09AE03

11.1.2017.

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

—

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

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 9.1.2017. | Novaquin | Le Vet Beheer B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/15/186 | 11.1.2017. |
| 18.1.2017. | Nobilis IB 4-91 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/98/006 | 20.1.2017. |
| 18.1.2017. | Simparica | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/15/191 | 20.1.2017. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

9.1.2017.

Novaquin

Le Vet Beheer B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/15/186

11.1.2017.

18.1.2017.

Nobilis IB 4-91

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/98/006

20.1.2017.

18.1.2017.

Simparica

Zoetis Belgium S.A.

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

EU/2/15/191

20.1.2017.

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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