# Il-Ġurnal Uffiċjali C 154/29 t

| | ISSN 1977-0987 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 154 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5929 ta' April 2016 |

ISSN 1977-0987

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 154

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5929 ta' April 2016

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| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2016/C 154/01 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Marzu 2016 sal-31 ta’ Marzu 2016(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2016/C 154/02 | Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Marzu 2016 sal-31 ta’ Marzu 2016(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 8 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2016/C 154/01

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Marzu 2016 sal-31 ta’ Marzu 2016(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

1

2016/C 154/02

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Marzu 2016 sal-31 ta’ Marzu 2016(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

8

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| MT | |
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MT

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IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 29.4.2016 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 154/1 |
| --- | --- | --- | --- |

29.4.2016

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 154/1

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Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Marzu 2016 sal-31 ta’ Marzu 2016

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (1))

(2016/C 154/01)

—   Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta’ notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.3.2016 | Coagadex | Fattur X koagulazzjoni umana | Bio Products Laboratory Ltd
  Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom | EU/1/16/1087 | Trab u solvent għal soluzzjoni għall-injezzjoni | B02BD13 | 18.3.2016 |
| 16.3.2016 | Neofordex | Dexamethasone | Laboratoires CTRS
  63 rue de l’Est, F-92100 Boulogne-Billancourt, France | EU/1/15/1053 | Pillola | H02AB02 | 18.3.2016 |
| 22.3.2016 | Amlodipine/Valsartan Mylan | Amlodipine/Valsartan | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1092 | Pillola miksija b’rita | C09DB01 | 29.3.2016 |
| 31.3.2016 | Wakix | pitolisant hydrochloride | Bioprojet Pharma
  9 rue Rameau, F-75002 Paris, France | EU/1/15/1068 | Pillola miksija b’rita | N07XX11 | 4.4.2016 |
| 31.3.2016 | Zonisamide Mylan | zonisamide | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1093 | Kapsula, iebsa | N03AX15 | 4.4.2016 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta’ notifika

16.3.2016

Coagadex

Fattur X koagulazzjoni umana

Bio Products Laboratory Ltd

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

EU/1/16/1087

Trab u solvent għal soluzzjoni għall-injezzjoni

B02BD13

18.3.2016

16.3.2016

Neofordex

Dexamethasone

Laboratoires CTRS

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

EU/1/15/1053

Pillola

H02AB02

18.3.2016

22.3.2016

Amlodipine/Valsartan Mylan

Amlodipine/Valsartan

Mylan S.A.S

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

EU/1/16/1092

Pillola miksija b’rita

C09DB01

29.3.2016

31.3.2016

Wakix

pitolisant hydrochloride

Bioprojet Pharma

9 rue Rameau, F-75002 Paris, France

EU/1/15/1068

Pillola miksija b’rita

N07XX11

4.4.2016

31.3.2016

Zonisamide Mylan

zonisamide

Mylan S.A.S

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

EU/1/16/1093

Kapsula, iebsa

N03AX15

4.4.2016

—   Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta’ notifika |
| --- | --- | --- | --- | --- |
| 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 | Capecitabine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 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 | 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 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

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

Capecitabine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

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

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

—   Irtirar ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta’ notifika |
| --- | --- | --- | --- | --- |
| 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 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

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

—   Sospensjoni ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 20 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta’ notifika |
| --- | --- | --- | --- | --- |
| 23.3.2016 | Zydelig | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | 30.3.2016 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

23.3.2016

Zydelig

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

30.3.2016

—   Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta’ notifika |
| --- | --- | --- | --- | --- |
| 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 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta’ notifika

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

Kull min jixtieq jikkonsulta r-rapport ta’ evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

| 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)  ĠU L 136, 30.4.04, p. 1.

---

| 29.4.2016 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 154/8 |
| --- | --- | --- | --- |

29.4.2016

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 154/8

---

Sommarju ta’ deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Marzu 2016 sal-31 ta’ Marzu 2016

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE (1) jew l-Artikolu 38 tad-Direttiva 2001/82/KE (2))

(2016/C 154/02)

—   Ħruġ, manteniment jew modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta’ notifika |
| --- | --- | --- | --- | --- | --- |
| 22.3.2016 | Closamectin Pour-On Solution and associated names – Art 78 | Closantel and ivermectin | Ara l-Anness | Ara l-Anness | 29.3.2016 |
| 7.3.2016 | Rivastigmine Rectificative Decision PSUSA 2654 201501 | Rivastigmine | Mhux applikabbli | Mhux applikabbli | 8.3.2016 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta’ notifika

22.3.2016

Closamectin Pour-On Solution and associated names – Art 78

Closantel and ivermectin

Ara l-Anness

Ara l-Anness

29.3.2016

7.3.2016

Rivastigmine Rectificative Decision PSUSA 2654 201501

Rivastigmine

Mhux applikabbli

Mhux applikabbli

8.3.2016

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS

Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi ta’ annimali, mnejn għandhom jingħataw, detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri

| Stat Membru (EU/EEA) | Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq | Isem il-prodott | INN | Qawwa | Għamla Farmaċewtika | Speċi tal-annimal | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung für Rinder | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Il-Belġju | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin 5 mg/ml + 200 mg/ml pour-on oplossing voor rundvee | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Ir-Repubblika Ċeka | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin 5 mg/ml + 200 mg/ml roztok pro nalévání na hřbet – pour-on | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Id-Danimarka | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin Pour-On | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Franza | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Il-Ġermanja | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung zum Übergießen für Rinder | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Il-Greċja | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin 5 mg/ml + 200 mg/ml διάλυμα επίχυσης για Βοοειδή | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| L-Irlanda | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| L-Irlanda | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closivet Pour-On Solution for Cattle | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| L-Italja | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| L-Italja | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Vermax Pour-On 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Il-Polonja | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin Pour-On 5 mg/ml + 200 mg/ml, roztwór do polewania dla bydła | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Il-Portugall | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin FF 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Ir-Rumanija | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin 5 mg/ml + 200 mg/ml Soluţie Pour-On pentru bovine | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Spanja | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | CLOSAMECTIN 5 mg/ml + 200 mg/ml SOLUCION POUR-ON PARA BOVINO | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Spanja | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closivet Solución Pour-On | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| L-Iżvezja | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin vet 5 mg/ml+200 mg/ml Pour-on lösning till nöt | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Is-Slovenja | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin 5 mg/ml + 200 mg/ml Pour-On kožni poliv, raztopina za govedo | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| ls-Slovakkja | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin 5 mg/ml + 200 mg/ml pour-on roztok pre hovädzí dobytok | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Ir-Renju Unit | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closamectin 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Ir-Renju Unit | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Closiver 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |
| Ir-Renju Unit | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq | Norofas Pour-On Solution for Cattle | Closantel u Ivermectin | 5 mg/ml 200 mg/ml | Soluzzjoni biex tferragħ | Frat | Għal użu topiku |

Stat Membru (EU/EEA)

Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq

Isem il-prodott

INN

Qawwa

Għamla Farmaċewtika

Speċi tal-annimal

Mnjen jingħata

L-Awstrija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Il-Belġju

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Ir-Repubblika Ċeka

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Id-Danimarka

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

Closamectin Pour-On

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Franza

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Il-Ġermanja

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Il-Greċja

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

L-Irlanda

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

L-Irlanda

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

Closivet Pour-On Solution for Cattle

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

L-Italja

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

L-Italja

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Il-Polonja

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Il-Portugall

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Ir-Rumanija

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Spanja

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Spanja

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

Closivet Solución Pour-On

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

L-Iżvezja

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Is-Slovenja

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

ls-Slovakkja

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Ir-Renju Unit

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Ir-Renju Unit

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

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

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

Ir-Renju Unit

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP L-Irlanda ta’ Fuq

Norofas Pour-On Solution for Cattle

Closantel u Ivermectin

5 mg/ml 200 mg/ml

Soluzzjoni biex tferragħ

Frat

Għal użu topiku

---