# Il-Ġurnal Uffiċjali C 282/2013

| | ISSN 1977-0987
  doi:10.3000/19770987.C_2013.282.mlt |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 282 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5627 ta' Settembru 2013 |

ISSN 1977-0987

doi:10.3000/19770987.C_2013.282.mlt

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 282

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5627 ta' Settembru 2013

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2013/C 282/01 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Awwissu 2013 sal-31 ta’ Awwissu 2013(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2013/C 282/02 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta' Awwissu 2013 sal-31 ta' Awwissu 2013(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE
  ) | 6 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

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

Il-Kummissjoni Ewropea

2013/C 282/01

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Awwissu 2013 sal-31 ta’ Awwissu 2013(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

2013/C 282/02

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta' Awwissu 2013 sal-31 ta' Awwissu 2013(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

)

6

| MT | |
| --- | --- |

MT

---

IV Informazzjoni

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

Il-Kummissjoni Ewropea

| 27.9.2013 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 282/1 |
| --- | --- | --- | --- |

27.9.2013

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 282/1

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta’ Awwissu 2013 sal-31 ta’ Awwissu 2013

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

2013/C 282/01

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.8.2013 | Pomalidomide Celgene | Pomalidomide | Celgene Europe Limited |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |

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

5.8.2013

Pomalidomide Celgene

Pomalidomide

Celgene Europe Limited

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

EU/1/13/850

Kapsula, iebsa

L04AX06

8.8.2013

5.8.2013

Somatropin Biopartners

somatropin

| BioPartners GmbH |
| --- |
| Kaiserpassage 11, D-72764 Reutlingen, Deutschland |

BioPartners GmbH

Kaiserpassage 11, D-72764 Reutlingen, Deutschland

EU/1/13/849

Trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod

H01AC01

8.8.2013

12.8.2013

Voncento

fattur tal-koagulazzjoni tal-bniedem VIII/fattur von Willebrand tal-bniedem

CSL Behring GmbH

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

EU/1/13/857

Trab u solvent għal soluzzjoni għall-injezzjoni/infużjoni

B02BD06

14.8.2013

26.8.2013

AUBAGIO

teriflunomide

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/13/838

Pillola miksija b’rita

L04AA31

29.8.2013

26.8.2013

Cholib

Fenofibrate/Simvastatin

Abbott Healthcare Products Ltd

Mansbridge Road, West End Southampton, SO18 3JD, United Kingdom

EU/1/13/866

Pillola miksija b’rita

C10BA04

28.8.2013

26.8.2013

Nexium Control

esomeprazole

| AstraZeneca AB |
| --- |
| SE-151 85 Södertälje, Sverige |

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/860

Pillola gastro-reżistenti

A02BC05

29.8.2013

26.8.2013

Stivarga

Regorafenib

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/858

Pillola miksija b’rita

L01XE21

29.8.2013

26.8.2013

Tafinlar

DABRAFENIB

| GlaxoSmithKline Trading Services Limited |
| --- |
| 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland |

GlaxoSmithKline Trading Services Limited

6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland

EU/1/13/865

Kapsula, iebsa

L01XE23

29.8.2013

—   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 |
| --- | --- | --- | --- | --- |
| 5.8.2013 | Icandra | Novartis Europharm Limited |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

5.8.2013

Icandra

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/484

8.8.2013

5.8.2013

Marixino

| Consilient Health Ltd. |
| --- |
| Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland |

Consilient Health Ltd.

Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland

EU/1/13/820

8.8.2013

5.8.2013

Rasilamlo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/686

8.8.2013

5.8.2013

Xarelto

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/08/472

8.8.2013

5.8.2013

Zomarist

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/483

8.8.2013

12.8.2013

Circadin

| RAD Neurim Pharmaceuticals EEC Limited |
| --- |
| One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom |

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom

EU/1/07/392

14.8.2013

12.8.2013

Pixuvri

| CTI Life Sciences Ltd |
| --- |
| Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom |

CTI Life Sciences Ltd

Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom

EU/1/12/764

14.8.2013

12.8.2013

Signifor

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/12/753

14.8.2013

12.8.2013

Twynsta

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim International GmbH

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

EU/1/10/648

14.8.2013

12.8.2013

Zavesca

| Actelion Registration Ltd |
| --- |
| Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom |

Actelion Registration Ltd

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

EU/1/02/238

14.8.2013

14.8.2013

Conbriza

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

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

EU/1/09/511

19.8.2013

14.8.2013

FLUENZ

| MedImmune, LLC |
| --- |
| Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland |

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/10/661

19.8.2013

14.8.2013

IOA

| Organon N.V. |
| --- |
| Kloosterstraat 6, NL-5349 AB Oss, Nederland |

Organon N.V.

Kloosterstraat 6, NL-5349 AB Oss, Nederland

EU/1/11/689

19.8.2013

26.8.2013

ADCETRIS

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, London WC2B 4AE, United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/12/794

28.8.2013

26.8.2013

Azarga

| Alcon Laboratories (UK) Ltd. |
| --- |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |

Alcon Laboratories (UK) Ltd.

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

EU/1/08/482

29.8.2013

26.8.2013

Ceplene

| Meda AB |
| --- |
| Box 906, SE-170 09 Solna, Sverige |

Meda AB

Box 906, SE-170 09 Solna, Sverige

EU/1/08/477

28.8.2013

26.8.2013

Eliquis

| Bristol-Myers Squibb/Pfizer EEIG |
| --- |
| Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |

Bristol-Myers Squibb/Pfizer EEIG

Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/691

29.8.2013

26.8.2013

Eylea

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/12/797

28.8.2013

26.8.2013

Herceptin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

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

EU/1/00/145

28.8.2013

26.8.2013

Hirobriz Breezhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/594

29.8.2013

26.8.2013

Ifirmasta

| Krka, d. d., Novo mesto |
| --- |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija |

Krka, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/480

29.8.2013

26.8.2013

Ilaris

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/564

28.8.2013

26.8.2013

Inlyta

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

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

EU/1/12/777

29.8.2013

26.8.2013

Invega

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, België |

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/07/395

28.8.2013

26.8.2013

Keppra

| UCB Pharma S.A. |
| --- |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |

UCB Pharma S.A.

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

EU/1/00/146

29.8.2013

26.8.2013

Onbrez Breezhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/593

29.8.2013

26.8.2013

Oslif Breezhaler

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/586

28.8.2013

26.8.2013

Pramipexole Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10, NL-3542 DR Utrecht, Nederland |

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/08/490

29.8.2013

26.8.2013

Tarceva

| Roche Registration Limited |
| --- |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

Roche Registration Limited

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

EU/1/05/311

29.8.2013

26.8.2013

Tysabri

| Biogen Idec Limited |
| --- |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |

Biogen Idec Limited

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

EU/1/06/346

29.8.2013

26.8.2013

Ventavis

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/255

29.8.2013

26.8.2013

XALKORI

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited

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

EU/1/12/793

29.8.2013

26.8.2013

Zypadhera

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, NL-3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/08/479

29.8.2013

—   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 |
| --- | --- | --- | --- | --- |
| 5.8.2013 | Econor | Novartis Animal Health Austria GmbH |
| Biochemiestrasse 10, A-6250 Kundl, Österreich |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

5.8.2013

Econor

Novartis Animal Health Austria GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/2/98/010

9.8.2013

12.8.2013

Trocoxil

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

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

EU/2/08/084

14.8.2013

14.8.2013

Cerenia

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

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

EU/2/06/062

19.8.2013

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

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK-LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK-LONDON E14 4H

---

(1)  ĠU L 136, 30.4.2004, p. 1.

---

| 27.9.2013 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 282/6 |
| --- | --- | --- | --- |

27.9.2013

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 282/6

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 ta' Awwissu 2013 sal-31 ta' Awwissu 2013

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

2013/C 282/02

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

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 12.8.2013 | Soludox | Ara l-Anness I | Ara l-Anness I | 13.8.2013 |
| 12.8.2013 | STRENZEN | Ara l-Anness II | Ara l-Anness II | 14.8.2013 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

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

Stat Membru kkonċernat

Data ta' notifika

12.8.2013

Soludox

Ara l-Anness I

Ara l-Anness I

13.8.2013

12.8.2013

STRENZEN

Ara l-Anness II

Ara l-Anness II

14.8.2013

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS I

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTTI MEDIĊINALI VETERINARJI, SPEĊI LI FUQHOM GĦANDU JINTUŻA L-PRODOTT, MNEJN JINGĦATA, DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTAT MEMBRU

| Stat Membru/EEA | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem kummerċjali | INN | Għamla Farmaċewtika | Qawwa | Speċi li fuqhom għandu jintuża l-prodott | Mnejn Jingħata |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Awstrija | Eurovet Animal Health BV |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Stat Membru/EEA

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem kummerċjali

INN

Għamla Farmaċewtika

Qawwa

Speċi li fuqhom għandu jintuża l-prodott

Mnejn Jingħata

Awstrija

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Repubblika Ċeka

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g prášek pro podání v pitné vodě pro prasata

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Estonja

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g suukaudse lahuse pulber sigadele ja kanadele

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Finlandja

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g jauhe juomaveteen sekoitettavaksi sioille ja kanoille

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Franza

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 433 mg/g poudre pour administration dans l'eau de boisson des porcs et des poulets

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Ġermanja

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine und Hühner

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Greċja

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g υπό μορφή σκόνης για χρήση σε πόσιμο νερό για χοίρους και κοτόπουλα

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Italja

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g polvere da somministrare nell’acqua da bere per suini e polli

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Italja

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Acquadox 500 mg/g polvere da somministrare nell’acqua da bere per suini e polli

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Latvja

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g pulveris lietošanai ar dzeramo ūdeni cūkām un vistām

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Olanda

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g poeder voor toediening via het drinkwater voor varkens en kippen

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Slovakja

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g prášok na použitie v pitnej vode pre ošípané

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Spanja

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g polvo para administración en agua de bebida para porcino y pollos

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

Renju Unit

| Eurovet Animal Health BV |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| Olanda |

Eurovet Animal Health BV

Handelsweg 25

5531 AE Bladel

Olanda

Soludox 500 mg/g powder for use in drinking water for pigs and chickens

doxycycline hyclate

trab għall-użu fl-ilma tax-xorb

500 mg/g

Ħnieżer u tiġieġ

Mill-ħalq: mal-ilma tax-xorb

---

ANNESS II

LISTA TAL-ISEM, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT MEDIĊINALI VETERINARJU, SPEĊI TA’ ANNIMAL, METODU TA’ AMMINISTRAZZJONI, APPLIKANT FL-ISTATI MEMBRI

| Stat Membru UE/ŻEE | Applikant | Isem | INN | Għamla farmaċewtika | Qawwa | Speċi ta’ annimal | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Novartis Animal Health Inc. |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| L-Isvizzera |

Stat Membru UE/ŻEE

Applikant

Isem

INN

Għamla farmaċewtika

Qawwa

Speċi ta’ annimal

Mnejn jingħata

L-Awstrija

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

L-Isvizzera

STRENZEN 500/125 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine

Amoxicillin, clavulanic acid

Trab sabiex jintuża fl-ilma tax-xorb

500/125 mg/g

Majjali

Orali: F’ilma tax-xorb

Ir-Repubblika Ċeka

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| L-Isvizzera |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

L-Isvizzera

STRENZEN 500/125 mg/g prášek pro podání v pitné vodě pro prasata

Amoxicillin, clavulanic acid

Trab sabiex jintuża fl-ilma tax-xorb

500/125 mg/g

Majjali

Orali: F’ilma tax-xorb

Id-Danimarka

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| L-Isvizzera |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

L-Isvizzera

STRENZEN 500/125 mg pulver til anvendelse i drikkevand til svin

Amoxicillin, clavulanic acid

Trab sabiex jintuża fl-ilma tax-xorb

500/125 mg/g

Majjali

Orali: F’ilma tax-xorb

Franza

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| L-Isvizzera |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

L-Isvizzera

STRENZEN 500/125 mg/g poudre pour eau de boisson porcs

Amoxicillin, clavulanic acid

Trab sabiex jintuża fl-ilma tax-xorb

500/125 mg/g

Majjali

Orali: F’ilma tax-xorb

Il-Ġermanja

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| L-Isvizzera |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

L-Isvizzera

STRENZEN 500/125 mg/g Pulver zum Eingeben über das Trinkwasser für Schweine

Amoxicillin, clavulanic acid

Trab sabiex jintuża fl-ilma tax-xorb

500/125 mg/g

Majjali

Orali: F’ilma tax-xorb

L-Irlanda

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| L-Isvizzera |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

L-Isvizzera

STRENZEN 500/125 mg/g powder for use in drinking water for pigs

Amoxicillin, clavulanic acid

Trab sabiex jintuża fl-ilma tax-xorb

500/125 mg/g

Majjali

Orali: F’ilma tax-xorb

L-Italja

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| L-Isvizzera |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

L-Isvizzera

STRENZEN 500/125 mg/g polvere per somministrazione in acqua da bere per suini

Amoxicillin, clavulanic acid

Trab sabiex jintuża fl-ilma tax-xorb

500/125 mg/g

Majjali

Orali: F’ilma tax-xorb

Il-Pajjiżi l-Baxxi

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| L-Isvizzera |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

L-Isvizzera

STRENZEN 500/125 mg/g poeder voor gebruik in drinkwater voor varkens.

Amoxicillin, clavulanic acid

Trab sabiex jintuża fl-ilma tax-xorb

500/125 mg/g

Majjali

Orali: F’ilma tax-xorb

Il-Portugall

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| L-Isvizzera |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

L-Isvizzera

STRENZEN 500/125 mg/g pó para utilização na água de bebida em suínos

Amoxicillin, clavulanic acid

Trab sabiex jintuża fl-ilma tax-xorb

500/125 mg/g

Majjali

Orali: F’ilma tax-xorb

Spanja

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| L-Isvizzera |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

L-Isvizzera

STRENZEN 500/125 mg/g polvo para uso en agua de bebida para porcino

Amoxicillin, clavulanic acid

Trab sabiex jintuża fl-ilma tax-xorb

500/125 mg/g

Majjali

Orali: F’ilma tax-xorb

Ir-Renju Unit

| Novartis Animal Health Inc. |
| --- |
| Schwarzwaldallee 215 |
| CH-4058 Basel |
| L-Isvizzera |

Novartis Animal Health Inc.

Schwarzwaldallee 215

CH-4058 Basel

L-Isvizzera

STRENZEN 500/125 mg/g powder for use in drinking water for pigs

Amoxicillin, clavulanic acid

Trab sabiex jintuża fl-ilma tax-xorb

500/125 mg/g

Majjali

Orali: F’ilma tax-xorb

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