# Eiropas Savienības C 229/2016

| | ISSN 1977-0952 |
| --- | --- |
| Eiropas Savienības
  Oficiālais Vēstnesis | C 229 |
| | |
| Izdevums latviešu valodā | Informācija un paziņojumi | 59. sējums2016. gada 24. jūnijs |

ISSN 1977-0952

Eiropas Savienības

Oficiālais Vēstnesis

C 229

Izdevums latviešu valodā

Informācija un paziņojumi

59. sējums2016. gada 24. jūnijs

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| Paziņojums Nr. | Saturs | Lappuse |
| --- | --- | --- |
| | IV   Paziņojumi |
| | EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI |
| | Eiropas Komisija |
| 2016/C 229/01 | Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2016. gada 1. maija līdz 2016. gada 31. maijam(publicēts saskaņā ar Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 13. vai 38. pantu) | 1 |

Paziņojums Nr.

Saturs

Lappuse

IV   Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

2016/C 229/01

Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2016. gada 1. maija līdz 2016. gada 31. maijam(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 | |
| --- | --- |

LV

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IV Paziņojumi

EIROPAS SAVIENĪBAS IESTĀŽU UN STRUKTŪRU SNIEGTI PAZIŅOJUMI

Eiropas Komisija

| 24.6.2016 | LV | Eiropas Savienības Oficiālais Vēstnesis | C 229/1 |
| --- | --- | --- | --- |

24.6.2016

LV

Eiropas Savienības Oficiālais Vēstnesis

C 229/1

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Eiropas Savienības lēmumu kopsavilkums par zāļu tirdzniecības atļaujām no 2016. gada 1. maija līdz 2016. gada 31. maijam

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

(2016/C 229/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.5.2016. | Empliciti | elotuzumabum | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/16/1088 | Pulveris infūziju šķīduma koncentrāta pagatavošanai | L01XC23 | 13.5.2016. |
| 11.5.2016. | IDELVION | alfa albutrepenonakogs | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/16/1095 | Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | B02BD04 | 13.5.2016. |
| 12.5.2016. | ALPROLIX | alfa eftrenonakog (eftrenonacogum alfa) | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/16/1098 | Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai | B02BD04 | 13.5.2016. |
| 12.5.2016. | Uptravi | selexipag | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/15/1083 | Apvalkotās tabletes | B01AC27 | 19.5.2016. |
| 20.5.2016. | Darzalex | Daratumumabs | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/16/1101 | Koncentrāts infūziju šķīduma pagatavošanai | L01XC24 | 24.5.2016. |
| 20.5.2016. | Pandemic influenza vaccine H5N1 MedImmune | Pandēmiskās gripas vakcīna (H5N1) (dzīva, novājināta, intranazālai lietošanai) | MedImmune, LLC
  Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | EU/1/16/1089 | Deguna aerosola suspensija | J07BB03 | 24.5.2016. |
| 26.5.2016. | Galafold | migalastat | Amicus Therapeutics UK Ltd
  Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom | EU/1/15/1082 | Cietās kapsulas | Pending | 31.5.2016. |
| 26.5.2016. | Neparvis | sakubitrils/valsartāns | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/16/1103 | Apvalkotās tabletes | C09DX04 | 30.5.2016. |
| 26.5.2016. | Palonosetron Accord | palonosetron | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/16/1104 | Šķīdums injekcijai | A04AA05 | 31.5.2016. |

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

11.5.2016.

Empliciti

elotuzumabum

Bristol-Myers Squibb Pharma EEIG

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

EU/1/16/1088

Pulveris infūziju šķīduma koncentrāta pagatavošanai

L01XC23

13.5.2016.

11.5.2016.

IDELVION

alfa albutrepenonakogs

CSL Behring GmbH

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

EU/1/16/1095

Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

B02BD04

13.5.2016.

12.5.2016.

ALPROLIX

alfa eftrenonakog (eftrenonacogum alfa)

Biogen Idec Limited

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

EU/1/16/1098

Pulveris un šķīdinātājs injekciju šķīduma pagatavošanai

B02BD04

13.5.2016.

12.5.2016.

Uptravi

selexipag

Actelion Registration Ltd

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

EU/1/15/1083

Apvalkotās tabletes

B01AC27

19.5.2016.

20.5.2016.

Darzalex

Daratumumabs

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/16/1101

Koncentrāts infūziju šķīduma pagatavošanai

L01XC24

24.5.2016.

20.5.2016.

Pandemic influenza vaccine H5N1 MedImmune

Pandēmiskās gripas vakcīna (H5N1) (dzīva, novājināta, intranazālai lietošanai)

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/16/1089

Deguna aerosola suspensija

J07BB03

24.5.2016.

26.5.2016.

Galafold

migalastat

Amicus Therapeutics UK Ltd

Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom

EU/1/15/1082

Cietās kapsulas

Pending

31.5.2016.

26.5.2016.

Neparvis

sakubitrils/valsartāns

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/16/1103

Apvalkotās tabletes

C09DX04

30.5.2016.

26.5.2016.

Palonosetron Accord

palonosetron

Accord Healthcare Limited

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

EU/1/16/1104

Šķīdums injekcijai

A04AA05

31.5.2016.

—   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 |
| --- | --- | --- | --- | --- |
| 2.5.2016. | Bortezomib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1019 | 4.5.2016. |
| 2.5.2016. | Combivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/98/058 | 4.5.2016. |
| 2.5.2016. | Ebilfumin | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/14/915 | 4.5.2016. |
| 2.5.2016. | ellaOne | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/09/522 | 4.5.2016. |
| 2.5.2016. | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/11/678 | 4.5.2016. |
| 2.5.2016. | Harvoni | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | 4.5.2016. |
| 2.5.2016. | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, A-1030 Wien, Österreich | EU/1/08/501 | 4.5.2016. |
| 2.5.2016. | Lyxumia | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/811 | 4.5.2016. |
| 2.5.2016. | Norvir | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/96/016 | 4.5.2016. |
| 2.5.2016. | Quadramet | CIS bio international
  Boite Postale 32, F-91192 Gif-sur-Yvette, France | EU/1/97/057 | 4.5.2016. |
| 2.5.2016. | Synflorix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/09/508 | 4.5.2016. |
| 2.5.2016. | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 4.5.2016. |
| 11.5.2016. | Desloratadine Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/11/745 | 13.5.2016. |
| 11.5.2016. | Humalog | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/96/007 | 13.5.2016. |
| 11.5.2016. | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 13.5.2016. |
| 11.5.2016. | Imatinib Medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/13/876 | 13.5.2016. |
| 11.5.2016. | Inlyta | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/777 | 13.5.2016. |
| 11.5.2016. | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 13.5.2016. |
| 11.5.2016. | Plenadren | ViroPharma SPRL-BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/715 | 13.5.2016. |
| 11.5.2016. | Zerit | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/96/009 | 13.5.2016. |
| 12.5.2016. | Brimica Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/963 | 16.5.2016. |
| 12.5.2016. | Clopidogrel Mylan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/09/559 | 17.5.2016. |
| 12.5.2016. | Desloratadine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/732 | 17.5.2016. |
| 12.5.2016. | Docetaxel Winthrop | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/07/384 | 17.5.2016. |
| 12.5.2016. | Enurev Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/789 | 16.5.2016. |
| 12.5.2016. | Glybera | uniQure biopharma B.V.
  Meibergdreef 61, NL-1105 BA Amsterdam, Nederland | EU/1/12/791 | 17.5.2016. |
| 12.5.2016. | Integrilin | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/99/109 | 16.5.2016. |
| 12.5.2016. | NovoEight | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/13/888 | 17.5.2016. |
| 12.5.2016. | Seebri Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/788 | 16.5.2016. |
| 12.5.2016. | Tepadina | ADIENNE S.r.l.
  Via Galileo Galilei 19, 20867 Caponago (MB), Italia | EU/1/10/622 | 16.5.2016. |
| 12.5.2016. | Tovanor Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/790 | 16.5.2016. |
| 13.5.2016. | Hexacima | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/13/828 | 24.5.2016. |
| 17.5.2016. | Capecitabine SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/13/831 | 19.5.2016. |
| 17.5.2016. | Champix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/360 | 19.5.2016. |
| 17.5.2016. | Epivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/96/015 | 19.5.2016. |
| 17.5.2016. | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 19.5.2016. |
| 17.5.2016. | Wilzin | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/04/286 | 19.5.2016. |
| 20.5.2016. | Ceprotin | Baxter AG
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/01/190 | 24.5.2016. |
| 20.5.2016. | Clopidogrel Krka d.d. | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/562 | 24.5.2016. |
| 20.5.2016. | Gazyvaro | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/14/937 | 24.5.2016. |
| 20.5.2016. | Hexyon | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/13/829 | 24.5.2016. |
| 26.5.2016. | Actos | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/150 | 30.5.2016. |
| 26.5.2016. | Afinitor | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/538 | 30.5.2016. |
| 26.5.2016. | Buccolam | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/709 | 30.5.2016. |
| 26.5.2016. | Capecitabine medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/802 | 30.5.2016. |
| 26.5.2016. | Cayston | Gilead Sciences International Limited
  Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | EU/1/09/543 | 31.5.2016. |
| 26.5.2016. | Cinryze | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 30.5.2016. |
| 26.5.2016. | Clopidogrel/Acetylsalicylic acid Teva | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/942 | 30.5.2016. |
| 26.5.2016. | Clopidogrel HCS | HCS bvba
  H. Kennisstraat 53, B-2650 Edegem, België | EU/1/10/651 | 30.5.2016. |
| 26.5.2016. | Clopidogrel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/540 | 30.5.2016. |
| 26.5.2016. | Competact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/354 | 30.5.2016. |
| 26.5.2016. | Conbriza | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/09/511 | 31.5.2016. |
| 26.5.2016. | Constella | Allergan Pharmaceuticals International Ltd.
  Clonshaugh Business and Technology Park Coolock Dublin D17 E400, Ireland | EU/1/12/801 | 30.5.2016. |
| 26.5.2016. | DepoCyte | Pacira Limited
  Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom | EU/1/01/187 | 28.5.2016. |
| 26.5.2016. | Dexdor | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/718 | 30.5.2016. |
| 26.5.2016. | Duaklir Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/964 | 30.5.2016. |
| 26.5.2016. | Ferriprox | Apotex Europe B.V.
  Darwinweg 20, NL-2333 CR Leiden, Nederland | EU/1/99/108 | 30.5.2016. |
| 26.5.2016. | Firazyr | Shire Orphan Therapies GmbH
  Friedrichstraße 149, D-10117 Berlin, Deutschland | EU/1/08/461 | 30.5.2016. |
| 26.5.2016. | Glubrava | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/07/421 | 30.5.2016. |
| 26.5.2016. | Glustin | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/151 | 30.5.2016. |
| 26.5.2016. | HyQvia | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/13/840 | 30.5.2016. |
| 26.5.2016. | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/945 | 30.5.2016. |
| 26.5.2016. | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 31.5.2016. |
| 26.5.2016. | Levodopa/Carbidopa/Entacapone Orion | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/706 | 30.5.2016. |
| 26.5.2016. | Liprolog | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/01/195 | 30.5.2016. |
| 26.5.2016. | Mabthera | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/067 | 31.5.2016. |
| 26.5.2016. | Neulasta | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/02/227 | 30.5.2016. |
| 26.5.2016. | Nexium Control | Pfizer Consumer Healthcare Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/13/860 | 31.5.2016. |
| 26.5.2016. | Rixubis | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/14/970 | 30.5.2016. |
| 26.5.2016. | Strimvelis | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/16/1097 | 30.5.2016. |
| 26.5.2016. | Tandemact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/366 | 30.5.2016. |
| 26.5.2016. | Taxotere | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/95/002 | 30.5.2016. |
| 26.5.2016. | Trevicta | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/971 | 30.5.2016. |
| 26.5.2016. | Vibativ | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/11/705 | 28.5.2016. |
| 26.5.2016. | Victoza | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/09/529 | 30.5.2016. |
| 26.5.2016. | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 31.5.2016. |
| 26.5.2016. | Ytracis | CIS bio international
  Boite Postale 32, F-91192 Gif-sur-Yvette, France | EU/1/03/250 | 30.5.2016. |
| 26.5.2016. | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/714 | 30.5.2016. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

2.5.2016.

Bortezomib Accord

Accord Healthcare Limited

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

EU/1/15/1019

4.5.2016.

2.5.2016.

Combivir

ViiV Healthcare UK Limited

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

EU/1/98/058

4.5.2016.

2.5.2016.

Ebilfumin

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/14/915

4.5.2016.

2.5.2016.

ellaOne

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/09/522

4.5.2016.

2.5.2016.

HALAVEN

Eisai Europe Limited

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

EU/1/11/678

4.5.2016.

2.5.2016.

Harvoni

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

4.5.2016.

2.5.2016.

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, A-1030 Wien, Österreich

EU/1/08/501

4.5.2016.

2.5.2016.

Lyxumia

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/811

4.5.2016.

2.5.2016.

Norvir

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/96/016

4.5.2016.

2.5.2016.

Quadramet

CIS bio international

Boite Postale 32, F-91192 Gif-sur-Yvette, France

EU/1/97/057

4.5.2016.

2.5.2016.

Synflorix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/508

4.5.2016.

2.5.2016.

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

4.5.2016.

11.5.2016.

Desloratadine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/11/745

13.5.2016.

11.5.2016.

Humalog

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/007

13.5.2016.

11.5.2016.

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

13.5.2016.

11.5.2016.

Imatinib Medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/13/876

13.5.2016.

11.5.2016.

Inlyta

Pfizer Limited

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

EU/1/12/777

13.5.2016.

11.5.2016.

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

13.5.2016.

11.5.2016.

Plenadren

ViroPharma SPRL-BVBA

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

EU/1/11/715

13.5.2016.

11.5.2016.

Zerit

Bristol-Myers Squibb Pharma EEIG

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

EU/1/96/009

13.5.2016.

12.5.2016.

Brimica Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/963

16.5.2016.

12.5.2016.

Clopidogrel Mylan

Mylan S.A.S

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

EU/1/09/559

17.5.2016.

12.5.2016.

Desloratadine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/732

17.5.2016.

12.5.2016.

Docetaxel Winthrop

Aventis Pharma S.A.

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

EU/1/07/384

17.5.2016.

12.5.2016.

Enurev Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/789

16.5.2016.

12.5.2016.

Glybera

uniQure biopharma B.V.

Meibergdreef 61, NL-1105 BA Amsterdam, Nederland

EU/1/12/791

17.5.2016.

12.5.2016.

Integrilin

Glaxo Group Ltd

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

EU/1/99/109

16.5.2016.

12.5.2016.

NovoEight

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/13/888

17.5.2016.

12.5.2016.

Seebri Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/788

16.5.2016.

12.5.2016.

Tepadina

ADIENNE S.r.l.

Via Galileo Galilei 19, 20867 Caponago (MB), Italia

EU/1/10/622

16.5.2016.

12.5.2016.

Tovanor Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/790

16.5.2016.

13.5.2016.

Hexacima

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/13/828

24.5.2016.

17.5.2016.

Capecitabine SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/13/831

19.5.2016.

17.5.2016.

Champix

Pfizer Limited

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

EU/1/06/360

19.5.2016.

17.5.2016.

Epivir

ViiV Healthcare UK Limited

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

EU/1/96/015

19.5.2016.

17.5.2016.

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

19.5.2016.

17.5.2016.

Wilzin

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/04/286

19.5.2016.

20.5.2016.

Ceprotin

Baxter AG

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/01/190

24.5.2016.

20.5.2016.

Clopidogrel Krka d.d.

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

24.5.2016.

20.5.2016.

Gazyvaro

Roche Registration Limited

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

EU/1/14/937

24.5.2016.

20.5.2016.

Hexyon

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/13/829

24.5.2016.

26.5.2016.

Actos

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/150

30.5.2016.

26.5.2016.

Afinitor

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/538

30.5.2016.

26.5.2016.

Buccolam

Shire Services BVBA

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

EU/1/11/709

30.5.2016.

26.5.2016.

Capecitabine medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/802

30.5.2016.

26.5.2016.

Cayston

Gilead Sciences International Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543

31.5.2016.

26.5.2016.

Cinryze

Shire Services BVBA

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

EU/1/11/688

30.5.2016.

26.5.2016.

Clopidogrel/Acetylsalicylic acid Teva

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/942

30.5.2016.

26.5.2016.

Clopidogrel HCS

HCS bvba

H. Kennisstraat 53, B-2650 Edegem, België

EU/1/10/651

30.5.2016.

26.5.2016.

Clopidogrel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/540

30.5.2016.

26.5.2016.

Competact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/354

30.5.2016.

26.5.2016.

Conbriza

Pfizer Limited

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

EU/1/09/511

31.5.2016.

26.5.2016.

Constella

Allergan Pharmaceuticals International Ltd.

Clonshaugh Business and Technology Park Coolock Dublin D17 E400, Ireland

EU/1/12/801

30.5.2016.

26.5.2016.

DepoCyte

Pacira Limited

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

EU/1/01/187

28.5.2016.

26.5.2016.

Dexdor

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/718

30.5.2016.

26.5.2016.

Duaklir Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/964

30.5.2016.

26.5.2016.

Ferriprox

Apotex Europe B.V.

Darwinweg 20, NL-2333 CR Leiden, Nederland

EU/1/99/108

30.5.2016.

26.5.2016.

Firazyr

Shire Orphan Therapies GmbH

Friedrichstraße 149, D-10117 Berlin, Deutschland

EU/1/08/461

30.5.2016.

26.5.2016.

Glubrava

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/07/421

30.5.2016.

26.5.2016.

Glustin

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/151

30.5.2016.

26.5.2016.

HyQvia

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/13/840

30.5.2016.

26.5.2016.

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/945

30.5.2016.

26.5.2016.

Imnovid

Celgene Europe Limited

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

EU/1/13/850

31.5.2016.

26.5.2016.

Levodopa/Carbidopa/Entacapone Orion

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/706

30.5.2016.

26.5.2016.

Liprolog

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/01/195

30.5.2016.

26.5.2016.

Mabthera

Roche Registration Limited

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

EU/1/98/067

31.5.2016.

26.5.2016.

Neulasta

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/02/227

30.5.2016.

26.5.2016.

Nexium Control

Pfizer Consumer Healthcare Limited

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

EU/1/13/860

31.5.2016.

26.5.2016.

Rixubis

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/14/970

30.5.2016.

26.5.2016.

Strimvelis

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/16/1097

30.5.2016.

26.5.2016.

Tandemact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/366

30.5.2016.

26.5.2016.

Taxotere

Aventis Pharma S.A.

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

EU/1/95/002

30.5.2016.

26.5.2016.

Trevicta

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/971

30.5.2016.

26.5.2016.

Vibativ

Clinigen Healthcare Limited

Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom

EU/1/11/705

28.5.2016.

26.5.2016.

Victoza

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/09/529

30.5.2016.

26.5.2016.

XALKORI

Pfizer Limited

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

EU/1/12/793

31.5.2016.

26.5.2016.

Ytracis

CIS bio international

Boite Postale 32, F-91192 Gif-sur-Yvette, France

EU/1/03/250

30.5.2016.

26.5.2016.

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/714

30.5.2016.

—   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 |
| --- | --- | --- | --- | --- |
| 3.5.2016. | Suvaxyn PCV | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/099 | 20.5.2016. |
| 17.5.2016. | Apoquel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/13/154 | 19.5.2016. |
| 17.5.2016. | Bravecto | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/13/158 | 19.5.2016. |
| 17.5.2016. | MS-H Vaccine | Pharmsure International Ltd
  Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom | EU/2/11/126 | 19.5.2016. |
| 17.5.2016. | Proteq West Nile | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/11/129 | 19.5.2016. |
| 26.5.2016. | Aivlosin | ECO Animal Health Ltd
  78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom | EU/2/04/044 | 31.5.2016. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

3.5.2016.

Suvaxyn PCV

Zoetis Belgium S.A.

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

EU/2/09/099

20.5.2016.

17.5.2016.

Apoquel

Zoetis Belgium S.A.

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

EU/2/13/154

19.5.2016.

17.5.2016.

Bravecto

Intervet International B.V.

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

EU/2/13/158

19.5.2016.

17.5.2016.

MS-H Vaccine

Pharmsure International Ltd

Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom

EU/2/11/126

19.5.2016.

17.5.2016.

Proteq West Nile

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/11/129

19.5.2016.

26.5.2016.

Aivlosin

ECO Animal Health Ltd

78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom

EU/2/04/044

31.5.2016.

—   Tirdzniecības atļaujas izņemšana no aprites (Eiropas Parlamenta un Padomes Regulas (EK) Nr. 726/2004 38. pants)

| Lēmuma datums | Zāļu nosaukums | Tirdzniecības atļaujas turētājs | Ieraksta numurs Kopienas reģistrā | Paziņojuma datums |
| --- | --- | --- | --- | --- |
| 26.5.2016. | RevitaCAM | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/138 | 30.5.2016. |

Lēmuma datums

Zāļu nosaukums

Tirdzniecības atļaujas turētājs

Ieraksta numurs Kopienas reģistrā

Paziņojuma datums

26.5.2016.

RevitaCAM

Zoetis Belgium S.A.

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

EU/2/12/138

30.5.2016.

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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