# Uradni list C 154/29.

| | ISSN 1977-1045 |
| --- | --- |
| Uradni list
  Evropske unije | C 154 |
| | |
| Slovenska izdaja | Informacije in objave | Zvezek 5929. april 2016 |

ISSN 1977-1045

Uradni list

Evropske unije

C 154

Slovenska izdaja

Informacije in objave

Zvezek 5929. april 2016

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| Obvestilo št. | Vsebina | Stran |
| --- | --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska komisija |
| 2016/C 154/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. marca 2016 do 31. marca 2016(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) | 1 |
| 2016/C 154/02 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. marca 2016 do 31. marca 2016(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES) | 8 |

Obvestilo št.

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

2016/C 154/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. marca 2016 do 31. marca 2016(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

1

2016/C 154/02

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. marca 2016 do 31. marca 2016(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES)

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES ali člena 38 Direktive 2001/82/ES)

8

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| SL | |
| --- | --- |

SL

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IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

| 29.4.2016 | SL | Uradni list Evropske unije | C 154/1 |
| --- | --- | --- | --- |

29.4.2016

SL

Uradni list Evropske unije

C 154/1

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Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. marca 2016 do 31. marca 2016

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (1))

(2016/C 154/01)

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.3.2016 | Coagadex | humanega koagulacijskega faktorja X | Bio Products Laboratory Ltd
  Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom | EU/1/16/1087 | Prašek in vehikel za raztopino za injiciranje | B02BD13 | 18.3.2016 |
| 16.3.2016 | Neofordex | Deksametazon | Laboratoires CTRS
  63 rue de l’Est, F-92100 Boulogne-Billancourt, France | EU/1/15/1053 | Tableta | H02AB02 | 18.3.2016 |
| 22.3.2016 | Amlodipin/valsartan Mylan | Amlodipin/valsartan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1092 | Filmsko obložene tablete | C09DB01 | 29.3.2016 |
| 31.3.2016 | Wakix | pitolizantijevega klorida | Bioprojet Pharma
  9 rue Rameau, F-75002 Paris, France | EU/1/15/1068 | Filmsko obložene tablete | N07XX11 | 4.4.2016 |
| 31.3.2016 | Zonisamide Mylan | zonisamida | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1093 | Kapsula, trda | N03AX15 | 4.4.2016 |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

16.3.2016

Coagadex

humanega koagulacijskega faktorja X

Bio Products Laboratory Ltd

Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom

EU/1/16/1087

Prašek in vehikel za raztopino za injiciranje

B02BD13

18.3.2016

16.3.2016

Neofordex

Deksametazon

Laboratoires CTRS

63 rue de l’Est, F-92100 Boulogne-Billancourt, France

EU/1/15/1053

Tableta

H02AB02

18.3.2016

22.3.2016

Amlodipin/valsartan Mylan

Amlodipin/valsartan

Mylan S.A.S

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

EU/1/16/1092

Filmsko obložene tablete

C09DB01

29.3.2016

31.3.2016

Wakix

pitolizantijevega klorida

Bioprojet Pharma

9 rue Rameau, F-75002 Paris, France

EU/1/15/1068

Filmsko obložene tablete

N07XX11

4.4.2016

31.3.2016

Zonisamide Mylan

zonisamida

Mylan S.A.S

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

EU/1/16/1093

Kapsula, trda

N03AX15

4.4.2016

—   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 2.3.2016 | Copalia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/372 | 4.3.2016 |
| 2.3.2016 | Dafiro | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/371 | 4.3.2016 |
| 2.3.2016 | DuoPlavin | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/619 | 7.3.2016 |
| 2.3.2016 | Efavirenz Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/742 | 4.3.2016 |
| 2.3.2016 | Exforge HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/569 | 4.3.2016 |
| 2.3.2016 | Faslodex | AstraZeneca UK Limited
  Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom | EU/1/03/269 | 4.3.2016 |
| 2.3.2016 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 7.3.2016 |
| 2.3.2016 | Menveo | GSK Vaccines S.r.l.
  Via Fiorentina, 1, IT-53100 Siena, Italia | EU/1/10/614 | 4.3.2016 |
| 2.3.2016 | Mozobil | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/09/537 | 4.3.2016 |
| 2.3.2016 | Xydalba | Durata Therapeutics International B.V.
  Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland | EU/1/14/986 | 4.3.2016 |
| 7.3.2016 | Avamys | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/434 | 9.3.2016 |
| 7.3.2016 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/12/792 | 9.3.2016 |
| 7.3.2016 | Signifor | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/753 | 9.3.2016 |
| 7.3.2016 | Triumeq | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/14/940 | 9.3.2016 |
| 10.3.2016 | Celsentri | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/07/418 | 14.3.2016 |
| 10.3.2016 | Onglyza | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/09/545 | 14.3.2016 |
| 11.3.2016 | Deltyba | Otsuka Novel Products GmbH
  Erika-Mann-Straße 21, D-80636 München, Deutschland | EU/1/13/875 | 16.3.2016 |
| 11.3.2016 | Savene | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/06/350 | 16.3.2016 |
| 11.3.2016 | Topotecan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/552 | 16.3.2016 |
| 16.3.2016 | Cuprymina | SPARKLE S.r.l.
  Località Cavallino, 62010 Montecosaro (MC), Italia | EU/1/12/784 | 21.3.2016 |
| 22.3.2016 | Copalia HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/575 | 29.3.2016 |
| 22.3.2016 | Exforge | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/370 | 29.3.2016 |
| 22.3.2016 | Exjade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/356 | 29.3.2016 |
| 22.3.2016 | Iclusig | ARIAD Pharma Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 29.3.2016 |
| 22.3.2016 | Kepivance | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/05/314 | 29.3.2016 |
| 22.3.2016 | Laventair | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/899 | 29.3.2016 |
| 22.3.2016 | Mekinist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/931 | 29.3.2016 |
| 22.3.2016 | Pixuvri | CTI Life Sciences Ltd
  Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 29.3.2016 |
| 22.3.2016 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 29.3.2016 |
| 22.3.2016 | Zykadia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | 29.3.2016 |
| 23.3.2016 | Elocta | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/15/1046 | 30.3.2016 |
| 30.3.2016 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37, D-58638 Iserlohn, Deutschland | EU/1/07/412 | 1.4.2016 |
| 30.3.2016 | Anoro | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/898 | 1.4.2016 |
| 30.3.2016 | Evra | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/02/223 | 1.4.2016 |
| 30.3.2016 | TachoSil | Takeda Austria GmbH
  St.-Peter-Strasse 25, A-4020 Linz, Österreich | EU/1/04/277 | 1.4.2016 |
| 30.3.2016 | Vidaza | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/08/488 | 1.4.2016 |
| 31.3.2016 | Betmiga | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/12/809 | 4.4.2016 |
| 31.3.2016 | Binocrit | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/07/410 | 4.4.2016 |
| 31.3.2016 | Caelyx | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/96/011 | 4.4.2016 |
| 31.3.2016 | Ecansya | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/12/763 | 4.4.2016 |
| 31.3.2016 | Epoetin alfa Hexal | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411 | 4.4.2016 |
| 31.3.2016 | Eviplera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/11/737 | 4.4.2016 |
| 31.3.2016 | Giotrif | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/13/879 | 4.4.2016 |
| 31.3.2016 | Kapecitabin Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 4.4.2016 |
| 31.3.2016 | Lynparza | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/959 | 4.4.2016 |
| 31.3.2016 | Revatio | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/05/318 | 4.4.2016 |
| 31.3.2016 | Ruconest | Pharming Group N.V.
  Darwinweg 24, NL-2333 CR Leiden, Nederland | EU/1/10/641 | 4.4.2016 |
| 31.3.2016 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 4.4.2016 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

2.3.2016

Copalia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/372

4.3.2016

2.3.2016

Dafiro

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/371

4.3.2016

2.3.2016

DuoPlavin

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/10/619

7.3.2016

2.3.2016

Efavirenz Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/742

4.3.2016

2.3.2016

Exforge HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/569

4.3.2016

2.3.2016

Faslodex

AstraZeneca UK Limited

Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom

EU/1/03/269

4.3.2016

2.3.2016

Jentadueto

Boehringer Ingelheim International GmbH

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

EU/1/12/780

7.3.2016

2.3.2016

Menveo

GSK Vaccines S.r.l.

Via Fiorentina, 1, IT-53100 Siena, Italia

EU/1/10/614

4.3.2016

2.3.2016

Mozobil

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/09/537

4.3.2016

2.3.2016

Xydalba

Durata Therapeutics International B.V.

Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland

EU/1/14/986

4.3.2016

7.3.2016

Avamys

Glaxo Group Ltd

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

EU/1/07/434

9.3.2016

7.3.2016

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/12/792

9.3.2016

7.3.2016

Signifor

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/753

9.3.2016

7.3.2016

Triumeq

ViiV Healthcare UK Limited

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

EU/1/14/940

9.3.2016

10.3.2016

Celsentri

ViiV Healthcare UK Limited

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

EU/1/07/418

14.3.2016

10.3.2016

Onglyza

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/09/545

14.3.2016

11.3.2016

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, D-80636 München, Deutschland

EU/1/13/875

16.3.2016

11.3.2016

Savene

Clinigen Healthcare Limited

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

EU/1/06/350

16.3.2016

11.3.2016

Topotecan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/552

16.3.2016

16.3.2016

Cuprymina

SPARKLE S.r.l.

Località Cavallino, 62010 Montecosaro (MC), Italia

EU/1/12/784

21.3.2016

22.3.2016

Copalia HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/575

29.3.2016

22.3.2016

Exforge

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/370

29.3.2016

22.3.2016

Exjade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/356

29.3.2016

22.3.2016

Iclusig

ARIAD Pharma Ltd

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

EU/1/13/839

29.3.2016

22.3.2016

Kepivance

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/05/314

29.3.2016

22.3.2016

Laventair

Glaxo Group Ltd

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

EU/1/14/899

29.3.2016

22.3.2016

Mekinist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/931

29.3.2016

22.3.2016

Pixuvri

CTI Life Sciences Ltd

Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

29.3.2016

22.3.2016

Trajenta

Boehringer Ingelheim International GmbH

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

EU/1/11/707

29.3.2016

22.3.2016

Zykadia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

29.3.2016

23.3.2016

Elocta

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/15/1046

30.3.2016

30.3.2016

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, D-58638 Iserlohn, Deutschland

EU/1/07/412

1.4.2016

30.3.2016

Anoro

Glaxo Group Ltd

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

EU/1/14/898

1.4.2016

30.3.2016

Evra

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/02/223

1.4.2016

30.3.2016

TachoSil

Takeda Austria GmbH

St.-Peter-Strasse 25, A-4020 Linz, Österreich

EU/1/04/277

1.4.2016

30.3.2016

Vidaza

Celgene Europe Limited

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

EU/1/08/488

1.4.2016

31.3.2016

Betmiga

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/12/809

4.4.2016

31.3.2016

Binocrit

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/07/410

4.4.2016

31.3.2016

Caelyx

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/96/011

4.4.2016

31.3.2016

Ecansya

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/12/763

4.4.2016

31.3.2016

Epoetin alfa Hexal

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/07/411

4.4.2016

31.3.2016

Eviplera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/11/737

4.4.2016

31.3.2016

Giotrif

Boehringer Ingelheim International GmbH

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

EU/1/13/879

4.4.2016

31.3.2016

Kapecitabin Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

4.4.2016

31.3.2016

Lynparza

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/959

4.4.2016

31.3.2016

Revatio

Pfizer Limited

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

EU/1/05/318

4.4.2016

31.3.2016

Ruconest

Pharming Group N.V.

Darwinweg 24, NL-2333 CR Leiden, Nederland

EU/1/10/641

4.4.2016

31.3.2016

Vargatef

Boehringer Ingelheim International GmbH

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

EU/1/14/954

4.4.2016

—   Ukinitev dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 2.3.2016 | Nuedexta | Jenson Pharmaceutical Services Ltd
  Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom | EU/1/13/833 | 4.3.2016 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

2.3.2016

Nuedexta

Jenson Pharmaceutical Services Ltd

Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom

EU/1/13/833

4.3.2016

—   Umik dovoljenja za promet (člen 20 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 23.3.2016 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 30.3.2016 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

23.3.2016

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

30.3.2016

—   Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 8.3.2016 | Palladia | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/100 | 10.3.2016 |
| 15.3.2016 | BLUEVAC BTV8 | CZ Veterinaria, S.A.
  La Relva s/n, 36400 Porriño, España | EU/2/11/122 | 17.3.2016 |
| 15.3.2016 | Versican Plus DHPPi | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/169 | 17.3.2016 |
| 15.3.2016 | Versican Plus DHPPi/L4 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/164 | 17.3.2016 |
| 15.3.2016 | Versican Plus DHPPi/L4R | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/163 | 17.3.2016 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

8.3.2016

Palladia

Zoetis Belgium S.A.

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

EU/2/09/100

10.3.2016

15.3.2016

BLUEVAC BTV8

CZ Veterinaria, S.A.

La Relva s/n, 36400 Porriño, España

EU/2/11/122

17.3.2016

15.3.2016

Versican Plus DHPPi

Zoetis Belgium S.A.

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

EU/2/14/169

17.3.2016

15.3.2016

Versican Plus DHPPi/L4

Zoetis Belgium S.A.

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

EU/2/14/164

17.3.2016

15.3.2016

Versican Plus DHPPi/L4R

Zoetis Belgium S.A.

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

EU/2/14/163

17.3.2016

Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:

| 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)  UL L 136, 30.4.2004, str. 1.

---

| 29.4.2016 | SL | Uradni list Evropske unije | C 154/8 |
| --- | --- | --- | --- |

29.4.2016

SL

Uradni list Evropske unije

C 154/8

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. marca 2016 do 31. marca 2016

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES (1) ali člena 38 Direktive 2001/82/ES (2))

(2016/C 154/02)

—   Izdaja, ohranjanje ali sprememba nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- | --- |
| 22.3.2016 | Closamectin Pour-On Solution and associated names – Art 78 | Closantel and ivermectin | Glej Prilogo | Glej Prilogo | 29.3.2016 |
| 7.3.2016 | Rivastigmine Rectificative Decision PSUSA 2654 201501 | Rivastigmine | Ni relevantno | Ni relevantno | 8.3.2016 |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

22.3.2016

Closamectin Pour-On Solution and associated names – Art 78

Closantel and ivermectin

Glej Prilogo

Glej Prilogo

29.3.2016

7.3.2016

Rivastigmine Rectificative Decision PSUSA 2654 201501

Rivastigmine

Ni relevantno

Ni relevantno

8.3.2016

---

(1)  UL L 311, 28.11.2001, str. 67.

(2)  UL L 311, 28.11.2001, str. 1.

---

PRILOGA

Seznam imen, farmacevtskih oblik in jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, imetnikov dovoljenja za promet z zdravilom v državah članicah

| Država članica (EU/EGP) | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Mednarodno nelastniško ime (INN) | Jakost | Farmacevtska oblika | Živalska vrsta | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung für Rinder | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Belgija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin 5 mg/ml + 200 mg/ml pour-on oplossing voor rundvee | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Češka republika | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin 5 mg/ml + 200 mg/ml roztok pro nalévání na hřbet – pour-on | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Danska | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin Pour-On | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Francija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Nemčija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung zum Übergießen für Rinder | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Grčija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin 5 mg/ml + 200 mg/ml διάλυμα επίχυσης για Βοοειδή | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Irska | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Irska | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closivet Pour-On Solution for Cattle | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Italija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Italija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Vermax Pour-On 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Poljska | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin Pour-On 5 mg/ml + 200 mg/ml, roztwór do polewania dla bydła | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Portugalska | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin FF 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Romunija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin 5 mg/ml + 200 mg/ml Soluţie Pour-On pentru bovine | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Španija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | CLOSAMECTIN 5 mg/ml + 200 mg/ml SOLUCION POUR-ON PARA BOVINO | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Španija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closivet Solución Pour-On | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Švedska | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin vet 5 mg/ml+200 mg/ml Pour-on lösning till nöt | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Slovenija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin 5 mg/ml + 200 mg/ml Pour-On kožni poliv, raztopina za govedo | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Slovaška | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin 5 mg/ml + 200 mg/ml pour-on roztok pre hovädzí dobytok | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Velika Britanija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closamectin 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Velika Britanija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Closiver 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |
| Velika Britanija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska | Norofas Pour-On Solution for Cattle | Closantel in Ivermectin | 5 mg/ml 200 mg/ml | Kožni poliv, raztopina | Govedo | Topikalna uporaba |

Država članica (EU/EGP)

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Mednarodno nelastniško ime (INN)

Jakost

Farmacevtska oblika

Živalska vrsta

Pot uporabe zdravila

Avstrija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung für Rinder

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Belgija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin 5 mg/ml + 200 mg/ml pour-on oplossing voor rundvee

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Češka republika

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin 5 mg/ml + 200 mg/ml roztok pro nalévání na hřbet – pour-on

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Danska

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin Pour-On

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Francija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Nemčija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung zum Übergießen für Rinder

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Grčija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin 5 mg/ml + 200 mg/ml διάλυμα επίχυσης για Βοοειδή

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Irska

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Irska

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closivet Pour-On Solution for Cattle

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Italija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Italija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Vermax Pour-On 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Poljska

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin Pour-On 5 mg/ml + 200 mg/ml, roztwór do polewania dla bydła

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Portugalska

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin FF 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Romunija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin 5 mg/ml + 200 mg/ml Soluţie Pour-On pentru bovine

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Španija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

CLOSAMECTIN 5 mg/ml + 200 mg/ml SOLUCION POUR-ON PARA BOVINO

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Španija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closivet Solución Pour-On

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Švedska

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin vet 5 mg/ml+200 mg/ml Pour-on lösning till nöt

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Slovenija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin 5 mg/ml + 200 mg/ml Pour-On kožni poliv, raztopina za govedo

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Slovaška

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin 5 mg/ml + 200 mg/ml pour-on roztok pre hovädzí dobytok

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Velika Britanija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closamectin 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Velika Britanija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Closiver 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

Velika Britanija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Severna Irska

Norofas Pour-On Solution for Cattle

Closantel in Ivermectin

5 mg/ml 200 mg/ml

Kožni poliv, raztopina

Govedo

Topikalna uporaba

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