# Il-Ġurnal Uffiċjali C 264/2012

| | ISSN 1977-0987
  doi:10.3000/19770987.C_2012.264.mlt |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 264 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5531 ta' Awwissu 2012 |

ISSN 1977-0987

doi:10.3000/19770987.C_2012.264.mlt

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 264

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5531 ta' Awwissu 2012

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| 2012/C 264/01 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 Lulju 2012 sal-31 Lulju 2012(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2012/C 264/02 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 Lulju 2012 sal-31 Lulju 2012(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 9 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

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

2012/C 264/01

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 Lulju 2012 sal-31 Lulju 2012(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

2012/C 264/02

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 Lulju 2012 sal-31 Lulju 2012(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)

9

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

MT

---

IV Informazzjoni

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

| 31.8.2012 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 264/1 |
| --- | --- | --- | --- |

31.8.2012

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 264/1

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 Lulju 2012 sal-31 Lulju 2012

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

2012/C 264/01

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 20.7.2012 | Bretaris Genuair | aclidinium bromide | Almirall, S.A. |
| Ronda General Mitre, 151, 08022 Barcelona, España |

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

20.7.2012

Bretaris Genuair

aclidinium bromide

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/12/781/001-003

Trab li jittieħed man-nifs

R03BB05

25.7.2012

20.7.2012

Eklira Genuair

aclidinium bromide

| Almirall, S.A. |
| --- |
| Ronda General Mitre, 151, 08022 Barcelona, España |

Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/12/778/001-003

Trab li jittieħed man-nifs

R03BB05

25.7.2012

20.7.2012

Jentadueto

Linagliptin/metformin hydrochloride

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

Boehringer Ingelheim International GmbH

Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/12/780/001-028

Pillola miksija b’rita

A10BD11

25.7.2012

23.7.2012

Fycompa

Perampanel

| Eisai Europe Limited |
| --- |
| European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom |

Eisai Europe Limited

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

EU/1/12/776/001-016

Pillola miksija b’rita

N03AX22

25.7.2012

23.7.2012

Kalydeco

ivacaftor

| Vertex Pharmaceuticals (U.K.) Limited |
| --- |
| 88 Milton Park, Abingdon, Oxfordshire OX14 4RY, United Kingdom |

Vertex Pharmaceuticals (U.K.) Limited

88 Milton Park, Abingdon, Oxfordshire OX14 4RY, United Kingdom

EU/1/12/782/001-002

Pillola miksija b’rita

Pending

25.7.2012

—   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 |
| --- | --- | --- | --- | --- |
| 3.7.2012 | Insuman | Sanofi-Aventis Deutschland GmbH |
| D-65926 Frankfurt am Main, Deutschland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

3.7.2012

Insuman

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030/028-201

5.7.2012

3.7.2012

Kinzalkomb

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

Bayer Pharma AG

Berlin 13342, Deutschland

EU/1/02/214/001-015

5.7.2012

3.7.2012

MicardisPlus

| 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/1/02/213/001-023

5.7.2012

3.7.2012

Prevenar 13

| Wyeth-Lederle Vaccines S.A. |
| --- |
| Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel - Bruxelles, Belgïe-Belgique |

Wyeth-Lederle Vaccines S.A.

Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel - Bruxelles, Belgïe-Belgique

EU/1/09/590/001-006

5.7.2012

4.7.2012

Arixtra

| Glaxo Group Ltd. |
| --- |
| Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd.

Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/02/206/001-035

6.7.2012

4.7.2012

Iasibon

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/10/659/001-010

6.7.2012

4.7.2012

Potactasol

| Actavis Group PTC ehf. |
| --- |
| Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland |

Actavis Group PTC ehf.

Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland

EU/1/10/660/001-002

6.7.2012

6.7.2012

Ganfort

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, Co. Mayo, Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/06/340/001-002

10.7.2012

6.7.2012

Olazax

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika

EU/1/09/597/001-005

10.7.2012

6.7.2012

Simulect

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

Novartis Europharm Ltd

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

EU/1/98/084/001-002

10.7.2012

6.7.2012

Trizivir

| ViiV Healthcare UK Limited |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

ViiV Healthcare UK Limited

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

EU/1/00/156/002-004

10.7.2012

12.7.2012

Edarbi

| 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/1/11/734/001-018

17.7.2012

12.7.2012

Ipreziv

| 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/1/11/735/001-018

17.7.2012

16.7.2012

Olanzapine Glenmark

| Glenmark Generics (Europe) Limited |
| --- |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |

Glenmark Generics (Europe) Limited

Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom

EU/1/09/587/001-017

18.7.2012

20.7.2012

Arzerra

| Glaxo Group Ltd |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/10/625/001

EU/1/10/625/003

24.7.2012

20.7.2012

Avamys

| Glaxo Group Ltd |
| --- |
| Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd

Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/434/001-003

24.7.2012

20.7.2012

BeneFIX

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

Pfizer Limited

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

EU/1/97/047/004-007

25.7.2012

20.7.2012

Celsentri

| ViiV Healthcare UK Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

ViiV Healthcare UK Ltd

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

EU/1/07/418/001-010

25.7.2012

20.7.2012

Cyanokit

| Merck Santé s.a.s. |
| --- |
| 37, rue Saint-Romain, 69379 Lyon Cedex 08, France |

Merck Santé s.a.s.

37, rue Saint-Romain, 69379 Lyon Cedex 08, France

EU/1/07/420/001-002

25.7.2012

20.7.2012

InductOs

| Medtronic Biopharma BV |
| --- |
| Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland |

Medtronic Biopharma BV

Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland

EU/1/02/226/001

25.7.2012

20.7.2012

Intelence

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/468/001-002

24.7.2012

23.7.2012

Afinitor

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

Novartis Europharm Ltd

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

EU/1/09/538/001-008

25.7.2012

23.7.2012

Alimta

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

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/290/001-002

27.7.2012

23.7.2012

Bridion

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

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/08/466/001-002

25.7.2012

23.7.2012

Cayston

| Gilead Sciences International Limited |
| --- |
| Granta Park, Abington, Cambridge CB21 6GT, United Kingdom |

Gilead Sciences International Limited

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

EU/1/09/543/001-002

25.7.2012

23.7.2012

Epivir

| ViiV Healthcare UK Ltd |
| --- |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |

ViiV Healthcare UK Ltd

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

EU/1/96/015/001-005

27.7.2012

23.7.2012

Eucreas

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

Novartis Europharm Ltd

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

EU/1/07/425/001-018

25.7.2012

23.7.2012

Galvus

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

Novartis Europharm Ltd

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

EU/1/07/414/001-010

EU/1/07/414/018

27.7.2012

23.7.2012

Humira

| Abbott Laboratories Ltd |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom |

Abbott Laboratories Ltd

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom

EU/1/03/256/001-010

27.7.2012

23.7.2012

Ketek

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron, F-92160 Antony, France |

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92160 Antony, France

EU/1/01/191/001-005

25.7.2012

23.7.2012

Lumigan

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, Westport, Co. Mayo, Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/02/205/001-004

25.7.2012

23.7.2012

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/1/09/586/001-010

25.7.2012

26.7.2012

Celvapan

| Baxter AG |
| --- |
| Industriestraße 67, A-1221 Wien, Österreich |

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/08/506/001

30.7.2012

26.7.2012

Esmya

| PregLem France SAS. |
| --- |
| 32, route de l'Eglise, 74140 Massongy, France |

PregLem France SAS.

32, route de l'Eglise, 74140 Massongy, France

EU/1/12/750/001

30.7.2012

26.7.2012

Evicel

| Omrix Biopharmaceuticals N.V. |
| --- |
| Leonardo Da Vinci Laan 15, B-1831 Diegem, België |

Omrix Biopharmaceuticals N.V.

Leonardo Da Vinci Laan 15, B-1831 Diegem, België

EU/1/08/473/001-003

30.7.2012

26.7.2012

Grepid

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535/001-016

30.7.2012

26.7.2012

Onbrez Breezhaler

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

Novartis Europharm Ltd

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

EU/1/09/593/001-010

30.7.2012

26.7.2012

Pradaxa

| 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/1/08/442/001-016

30.7.2012

26.7.2012

Silapo

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland |

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland

EU/1/07/432/001-022

30.7.2012

26.7.2012

Votubia

| 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/1/11/710/001-007

30.7.2012

26.7.2012

Zalasta

| 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/1/07/415/001-056

30.7.2012

31.7.2012

Enbrel

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

Pfizer Limited

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

EU/1/99/126/001-022

3.8.2012

31.7.2012

Isentress

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/07/436/001-002

3.8.2012

31.7.2012

NovoRapid

| Novo Nordisk A/S |
| --- |
| Novo Allé, DK-2880 Bagsvaerd, Danmark |

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-015

EU/1/99/119/017-023

3.8.2012

31.7.2012

Tyverb

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/440/001-007

2.8.2012

31.7.2012

Victrelis

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/11/704/001-002

3.8.2012

—   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 |
| --- | --- | --- | --- | --- |
| 4.7.2012 | Sprimeo | Novartis Europharm Ltd |
| 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

4.7.2012

Sprimeo

Novartis Europharm Ltd

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

EU/1/07/407/001-040

6.7.2012

6.7.2012

Sprimeo HCT

| 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/1/11/683/001-080

10.7.2012

16.7.2012

Regranex

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/99/101/001

18.7.2012

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
   (2)
  ): 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.7.2012 | Nobivac L4 | — | Intervet International B.V. |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |

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

16.7.2012

Nobivac L4

—

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/12/143/001-005

Suspensjoni għall-injezzjoni

QI07AB01

18.7.2012

23.7.2012

Cardalis

Benazepril hydrochloride, Spironolactone

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, 33500 Libourne, France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/12/142/001-006

Pillola

QC09BA07

25.7.2012

—   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 |
| --- | --- | --- | --- | --- |
| 4.7.2012 | Proteq West Nile | MERIAL |
| 29 avenue Tony Garnier, 69007 LYON, France |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

4.7.2012

Proteq West Nile

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/11/129/001-004

6.7.2012

6.7.2012

Vaxxitek HVT+ IBD

| Merial |
| --- |
| 29 Avenue Tony Garnier, 69007 Lyon, France |

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/02/032/001-002

10.7.2012

12.7.2012

Ingelvac CircoFLEX

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/07/079/001-008

17.7.2012

12.7.2012

Novem

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/04/042/001-014

17.7.2012

20.7.2012

ProMeris

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

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/06/064/001-004

25.7.2012

20.7.2012

ProMeris Duo

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

Pfizer Limited

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

EU/2/06/065/001-010

25.7.2012

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.

(2)  ĠU L 136, 30.4.2004, p. 1.

---

| 31.8.2012 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 264/9 |
| --- | --- | --- | --- |

31.8.2012

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 264/9

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali mill-1 Lulju 2012 sal-31 Lulju 2012

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

2012/C 264/02

—   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 |
| --- | --- | --- | --- | --- |
| 31.7.2012 | Tavanic and associated names | Ara l-Anness I | Ara l-Anness I | 2.8.2012 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

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

Stat Membru kkonċernat

Data ta' notifika

31.7.2012

Tavanic and associated names

Ara l-Anness I

Ara l-Anness I

2.8.2012

—   Ir-rifjut ta' modifika ta' awtorizzazzjoni nazzjonali 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 |
| --- | --- | --- | --- | --- |
| 6.7.2012 | Ethinylestradiol-Drospirenone 24 + 4 and associated names | Ara l-Anness II | Ara l-Anness II | 10.7.2012 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

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

Stat Membru kkonċernat

Data ta' notifika

6.7.2012

Ethinylestradiol-Drospirenone 24 + 4 and associated names

Ara l-Anness II

Ara l-Anness II

10.7.2012

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS I

LISTA TAL-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/ŻEE | Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq> | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Sanofi-aventis GmbH |
| Leonard-Bernstein-Straße 10, A-1220 Vienna |

Stat Membru UE/ŻEE

Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq>

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Sanofi-aventis GmbH

Leonard-Bernstein-Straße 10, A-1220 Vienna

Tavanic 250 mg Filmtabletten

250 mg

Pilloli miksijin b‘rita

Għall-użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| Leonard-Bernstein-Straße 10, A-1220 Vienna |

Sanofi-aventis GmbH

Leonard-Bernstein-Straße 10, A-1220 Vienna

Tavanic 500 mg Filmtabletten

500 mg

Pilloli miksijin b‘rita

Għall-użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| Leonard-Bernstein-Straße 10, A-1220 Vienna |

Sanofi-aventis GmbH

Leonard-Bernstein-Straße 10, A-1220 Vienna

Tavanic Infusionsflasche

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Il-Belġju

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem – Il-Belġju |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem – Il-Belġju

Tavanic 250 mg filmomhulde tabletten

250 mg

Pilloli miksijin b‘rita

Għall-użu orali

Il-Belġju

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem – Il-Belġju |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem – Il-Belġju

Tavanic 500 mg filmomhulde tabletten

500 mg

Pilloli miksijin b‘rita

Għall-użu orali

Il-Belġju

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem – Il-Belġju |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem – Il-Belġju

Tavanic 5 mg/ml oplossing voor infusie

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Il-Bulgarija

| Sanofi-Avenstis Bulgaria EOOD, |
| --- |
| Il-Bulgarija, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 |

Sanofi-Avenstis Bulgaria EOOD,

Il-Bulgarija, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8

Tavanic

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Bulgarija

| Sanofi-Avenstis Bulgaria EOOD, |
| --- |
| Il-Bulgarija, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 |

Sanofi-Avenstis Bulgaria EOOD,

Il-Bulgarija, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8

Tavanic

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Bulgarija

| Sanofi-Avenstis Bulgaria EOOD, |
| --- |
| Il-Bulgarija, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8 |

Sanofi-Avenstis Bulgaria EOOD,

Il-Bulgarija, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8

Tavanic

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Ċipru

| Sanofi-aventis Cyprus Ltd, |
| --- |
| 14 Charalambou Mouskou street, 2015 – Nicosia, Ċipru |

Sanofi-aventis Cyprus Ltd,

14 Charalambou Mouskou street, 2015 – Nicosia, Ċipru

Tavanic

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Ċipru

| Sanofi-aventis Cyprus Ltd, |
| --- |
| 14 Charalambou Mouskou street, 2015 – Nicosia, Ċipru |

Sanofi-aventis Cyprus Ltd,

14 Charalambou Mouskou street, 2015 – Nicosia, Ċipru

Tavanic

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Ċipru

| Sanofi-aventis Cyprus Ltd, |
| --- |
| 14 Charalambou Mouskou street, 2015 – Nicosia, Ċipru |

Sanofi-aventis Cyprus Ltd,

14 Charalambou Mouskou street, 2015 – Nicosia, Ċipru

Tavanic

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Ir-Repubblika Ċeka

| sanofi-aventis, s.r.o. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Ir-Repubblika Ċeka |

sanofi-aventis, s.r.o.

Evropská 846/176a

160 00 Praha 6

Ir-Repubblika Ċeka

Tavanic i.v.

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

L-Estonja

| sanofi-aventis Estonia OÜ, |
| --- |
| Pärnu mnt 139 E/2, 11317 Tallinn, L-Estonja |

sanofi-aventis Estonia OÜ,

Pärnu mnt 139 E/2, 11317 Tallinn, L-Estonja

Tavanic

250 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Estonja

| sanofi-aventis Estonia OÜ, |
| --- |
| Pärnu mnt 139 E/2, 11317 Tallinn, L-Estonja |

sanofi-aventis Estonia OÜ,

Pärnu mnt 139 E/2, 11317 Tallinn, L-Estonja

Tavanic

500 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Estonja

| sanofi-aventis Estonia OÜ, |
| --- |
| Pärnu mnt 139 E/2, 11317 Tallinn, L-Estonja |

sanofi-aventis Estonia OÜ,

Pärnu mnt 139 E/2, 11317 Tallinn, L-Estonja

Tavanic

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki, Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki, Il-Finlandja

Tavanic

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki, Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki, Il-Finlandja

Tavanic

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki, Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

00350 Helsinki, Il-Finlandja

Tavanic

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Franza

| Sanofi-aventis France |
| --- |
| 1-13 Boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-aventis France

1-13 Boulevard Romain Rolland

75014 Paris

Franza

TAVANIC 250 mg comprimé pelliculé sécable

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Franza

| Sanofi-aventis France |
| --- |
| 1-13 Boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-aventis France

1-13 Boulevard Romain Rolland

75014 Paris

Franza

TAVANIC 500 mg comprimé pelliculé sécable

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Franza

| Sanofi-aventis France |
| --- |
| 1-13 Boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-aventis France

1-13 Boulevard Romain Rolland

75014 Paris

Franza

TAVANIC 5 mg/ml solution pour perfusion

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH, |
| --- |
| Industriepark Höchst, |
| Gebäude K703 |
| 65926 Frankfurt am Main, Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH,

Industriepark Höchst,

Gebäude K703

65926 Frankfurt am Main, Il-Ġermanja

Tavanic 250 mg Filmtabletten

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH, |
| --- |
| Industriepark Höchst, |
| Gebäude K703 |
| 65926 Frankfurt am Main, Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH,

Industriepark Höchst,

Gebäude K703

65926 Frankfurt am Main, Il-Ġermanja

Tavanic 500 mg Filmtabletten

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH, |
| --- |
| Industriepark Höchst, |
| Gebäude K703 |
| 65926 Frankfurt am Main, Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH,

Industriepark Höchst,

Gebäude K703

65926 Frankfurt am Main, Il-Ġermanja

Tavanic 5 mg/ml Infusionslösung

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Il-Greċja

| sanofi-aventis AEBE |
| --- |
| 348 Syngrou avenue-Building A |
| 176 74 Kalithea – Athens |
| GR-Il-Greċja |

sanofi-aventis AEBE

348 Syngrou avenue-Building A

176 74 Kalithea – Athens

GR-Il-Greċja

Tavanic

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Greċja

| sanofi-aventis AEBE |
| --- |
| 348 Syngrou avenue-Building A |
| 176 74 Kalithea – Athens |
| GR- Il-Greċja |

sanofi-aventis AEBE

348 Syngrou avenue-Building A

176 74 Kalithea – Athens

GR- Il-Greċja

Tavanic

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Greċja

| sanofi-aventis AEBE |
| --- |
| 348 Syngrou avenue-Building A |
| 176 74 Kalithea – Athens |
| GR- Il-Greċja |

sanofi-aventis AEBE

348 Syngrou avenue-Building A

176 74 Kalithea – Athens

GR- Il-Greċja

Tavanic

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

L-Ungerija

| sanofi-aventis Zrt. |
| --- |
| To u. 1-5. |
| 1045 Budapest, |
| L-Ungerija |

sanofi-aventis Zrt.

To u. 1-5.

1045 Budapest,

L-Ungerija

Tavanic

250 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Ungerija

| sanofi-aventis Zrt. |
| --- |
| To u. 1-5. |
| 1045 Budapest, |
| L-Ungerija |

sanofi-aventis Zrt.

To u. 1-5.

1045 Budapest,

L-Ungerija

Tavanic

500 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Ungerija

| sanofi-aventis Zrt. |
| --- |
| To u. 1-5. |
| 1045 Budapest, |
| L-Ungerija |

sanofi-aventis Zrt.

To u. 1-5.

1045 Budapest,

L-Ungerija

Tavanic

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

L-Irlanda

| sanofi-aventis Ireland Ltd., |
| --- |
| Citywest Business Campus, Dublin 24, L-Irlanda |

sanofi-aventis Ireland Ltd.,

Citywest Business Campus, Dublin 24, L-Irlanda

Tavanic 250 mg film-coated tablets

250 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Irlanda

| sanofi-aventis Ireland Ltd., |
| --- |
| Citywest Business Campus, Dublin 24, L-Irlanda |

sanofi-aventis Ireland Ltd.,

Citywest Business Campus, Dublin 24, L-Irlanda

Tavanic 500 mg film-coated tablets

500 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Irlanda

| sanofi-aventis Ireland Ltd., |
| --- |
| Citywest Business Campus, Dublin 24, L-Irlanda |

sanofi-aventis Ireland Ltd.,

Citywest Business Campus, Dublin 24, L-Irlanda

Tavanic 5 mg/ml solution for infusion

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

L-Italja

| sanofi-aventis S.p.A. |
| --- |
| Viale Luigi Bodio 37/B |
| 20158 Milan |
| L-Italja |

sanofi-aventis S.p.A.

Viale Luigi Bodio 37/B

20158 Milan

L-Italja

TAVANIC

250 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Italja

| sanofi-aventis S.p.A. |
| --- |
| Viale Luigi Bodio 37/B |
| 20158 Milan |
| L-Italja |

sanofi-aventis S.p.A.

Viale Luigi Bodio 37/B

20158 Milan

L-Italja

TAVANIC

500 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Italja

| sanofi-aventis S.p.A. |
| --- |
| Viale Luigi Bodio 37/B |
| 20158 Milan |
| L-Italja |

sanofi-aventis S.p.A.

Viale Luigi Bodio 37/B

20158 Milan

L-Italja

TAVANIC

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Il-Litwanja

| UAB “SANOFI-AVENTIS LIETUVA”, |
| --- |
| A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Il-Litwanja |

UAB “SANOFI-AVENTIS LIETUVA”,

A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Il-Litwanja

Tavanic

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Litwanja

| UAB “SANOFI-AVENTIS LIETUVA”, |
| --- |
| A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Il-Litwanja |

UAB “SANOFI-AVENTIS LIETUVA”,

A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Il-Litwanja

Tavanic

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Litwanja

| UAB “SANOFI-AVENTIS LIETUVA”, |
| --- |
| A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Il-Litwanja |

UAB “SANOFI-AVENTIS LIETUVA”,

A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Il-Litwanja

Tavanic

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Il-Lussumburgu

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem – Il-Belġju |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem – Il-Belġju

Tavanic 250 mg comprimés pelliculés

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Lussumburgu

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem – Il-Belġju |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem – Il-Belġju

Tavanic 500 mg comprimés pelliculés

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Lussumburgu

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan, 1C |
| 1831 Diegem – Il-Belġju |

Sanofi-aventis Belgium

Culliganlaan, 1C

1831 Diegem – Il-Belġju

Tavanic 5 mg/ml solution pour perfusion

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Malta

| Sanofi-Aventis Malta Ltd, |
| --- |
| Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta |

Sanofi-Aventis Malta Ltd,

Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta

Tavanic 250 mg film coated tablets

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Malta

| Sanofi-Aventis Malta Ltd, |
| --- |
| Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta |

Sanofi-Aventis Malta Ltd,

Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta

Tavanic 500 mg film coated tablets

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Malta

| Sanofi-Aventis Malta Ltd, |
| --- |
| Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta |

Sanofi-Aventis Malta Ltd,

Triq Kan. K. Pirotta, Birkirkara. BKR 1114. Malta

Tavanic 5 mg/ml solution for infusion

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

L-Olanda

| sanofi-aventis Netherlands B.V., |
| --- |
| Kampenringweg 45 D-E, 2803 PE Gouda, L-Olanda |

sanofi-aventis Netherlands B.V.,

Kampenringweg 45 D-E, 2803 PE Gouda, L-Olanda

Tavanic 250

250 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Olanda

| sanofi-aventis Netherlands B.V., |
| --- |
| Kampenringweg 45 D-E, 2803 PE Gouda, L-Olanda |

sanofi-aventis Netherlands B.V.,

Kampenringweg 45 D-E, 2803 PE Gouda, L-Olanda

Tavanic 500

500 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Olanda

| sanofi-aventis Netherlands B.V., |
| --- |
| Kampenringweg 45 D-E, 2803 PE Gouda, L-Olanda |

sanofi-aventis Netherlands B.V.,

Kampenringweg 45 D-E, 2803 PE Gouda, L-Olanda

Tavanic IV

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Il-Polonja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Brüningstrasse 50 |
| D-65926 Frankfurt am Main, Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

D-65926 Frankfurt am Main, Il-Ġermanja

Tavanic 250

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Polonja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Brüningstrasse 50 |
| D-65926 Frankfurt am Main, Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

D-65926 Frankfurt am Main, Il-Ġermanja

Tavanic 500

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Polonja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Brüningstrasse 50 |
| D-65926 Frankfurt am Main, Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Brüningstrasse 50

D-65926 Frankfurt am Main, Il-Ġermanja

Tavanic

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Il-Portugall

| SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 – 3o Piso |
| 2740-244 Porto Salvo |

SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

TAVANIC

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Portugall

| SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 – 3o Piso |
| 2740-244 Porto Salvo |

SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

TAVANIC

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Il-Portugall

| SANOFI-AVENTIS – Produtos Farmacêuticos, Lda. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 – 3o Piso |
| 2740-244 Porto Salvo |

SANOFI-AVENTIS – Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 7 – 3o Piso

2740-244 Porto Salvo

TAVANIC

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Is-Slovakkja

| sanofi-aventis Slovakia s.r.o., |
| --- |
| Einsteinova 24, 85101 Bratislava, Is-Slovakkja |

sanofi-aventis Slovakia s.r.o.,

Einsteinova 24, 85101 Bratislava, Is-Slovakkja

Tavanic 500 mg

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Is-Slovakkja

| sanofi-aventis Slovakia s.r.o., |
| --- |
| Einsteinova 24, 85101 Bratislava, Is-Slovakkja |

sanofi-aventis Slovakia s.r.o.,

Einsteinova 24, 85101 Bratislava, Is-Slovakkja

Tavanic i.v. 500 mg

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Is-Slovenja

| sanofi-aventis d.o.o, |
| --- |
| Dunajska 151, 1000 Ljubljana, Is-Slovenja |

sanofi-aventis d.o.o,

Dunajska 151, 1000 Ljubljana, Is-Slovenja

Tavanic 250 mg filmsko obložene tablete

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Is-Slovenja

| sanofi-aventis d.o.o, |
| --- |
| Dunajska 151, 1000 Ljubljana, Is-Slovenja |

sanofi-aventis d.o.o,

Dunajska 151, 1000 Ljubljana, Is-Slovenja

Tavanic 500 mg filmsko obložene tablete

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Is-Slovenja

| sanofi-aventis d.o.o, |
| --- |
| Dunajska 151, 1000 Ljubljana, Is-Slovenja |

sanofi-aventis d.o.o,

Dunajska 151, 1000 Ljubljana, Is-Slovenja

Tavanic 5 mg/ml raztopina za infundiranje

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Spanja

| Sanofi-aventis, S.A. |
| --- |
| Josep Pla, 2 |
| 08019 – Barcelona |
| Spanja |

Sanofi-aventis, S.A.

Josep Pla, 2

08019 – Barcelona

Spanja

Tavanic 500 mg comprimidos recubiertos con película

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Spanja

| Sanofi-aventis, S.A. |
| --- |
| Josep Pla, 2 |
| 08019 – Barcelona |
| Spanja |

Sanofi-aventis, S.A.

Josep Pla, 2

08019 – Barcelona

Spanja

Tavanic 5 mg/ml solución para perfusión

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

L-Isvezja

| sanofi-aventis AB |
| --- |
| Box 141 42 |
| 167 14 Bromma |
| L-Isvezja |

sanofi-aventis AB

Box 141 42

167 14 Bromma

L-Isvezja

Tavanic

250 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Isvezja

| sanofi-aventis AB |
| --- |
| Box 141 42 |
| 167 14 Bromma |
| L-Isvezja |

sanofi-aventis AB

Box 141 42

167 14 Bromma

L-Isvezja

Tavanic

500 mg

Pilloli miksijin b’rita

Għall-użu orali

L-Isvezja

| sanofi-aventis AB |
| --- |
| Box 141 42 |
| 167 14 Bromma |
| L-Isvezja |

sanofi-aventis AB

Box 141 42

167 14 Bromma

L-Isvezja

Tavanic

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

Ir-Renju Unit

| Aventis Pharma Limited, |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent |
| ME19 4AH |
| Ir-Renju Unit |

Aventis Pharma Limited,

50 Kings Hill Avenue

Kings Hill

West Malling

Kent

ME19 4AH

Ir-Renju Unit

(Trading as:

| Sanofi-aventis |
| --- |
| One Onslow Street, Guildford, Surrey, |
| GU1 4YS, Ir-Renju Unit) |

Sanofi-aventis

One Onslow Street, Guildford, Surrey,

GU1 4YS, Ir-Renju Unit)

Tavanic 250 mg film-coated tablets

250 mg

Pilloli miksijin b’rita

Għall-użu orali

Ir-Renju Unit

| Aventis Pharma Limited, |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent |
| ME19 4AH |
| Ir-Renju Unit |

Aventis Pharma Limited,

50 Kings Hill Avenue

Kings Hill

West Malling

Kent

ME19 4AH

Ir-Renju Unit

(Trading as:

| Sanofi-aventis |
| --- |
| One Onslow Street, Guildford, Surrey, |
| GU1 4YS, Ir-Renju Unit) |

Sanofi-aventis

One Onslow Street, Guildford, Surrey,

GU1 4YS, Ir-Renju Unit)

Tavanic 500 mg film-coated tablets

500 mg

Pilloli miksijin b’rita

Għall-użu orali

Ir-Renju Unit

| Aventis Pharma Limited, |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent |
| ME19 4AH |
| Ir-Renju Unit |

Aventis Pharma Limited,

50 Kings Hill Avenue

Kings Hill

West Malling

Kent

ME19 4AH

Ir-Renju Unit

(Trading as:

| Sanofi-aventis |
| --- |
| One Onslow Street, Guildford, Surrey, |
| GU1 4YS, Ir-Renju Unit) |

Sanofi-aventis

One Onslow Street, Guildford, Surrey,

GU1 4YS, Ir-Renju Unit)

Tavanic 5 mg/ml solution for infusion

5 mg/ml

Soluzzjoni għall-infużjoni

Għall-użu minn ġol-vini

---

ANNESS II

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT(I) MEDIĊINALI, MNEJN JINGĦATA, ID-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 Mediċinali | Qawwa | Għamla Farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Bayer Austria GmbH |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Stat Membru

EU/EEA

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

Isem il-Prodott Mediċinali

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

L-Awstrija

Bayer Austria GmbH

Herbststrasse 6-10

1160 Wien

Austria

Eloine 0,02 mg/3 mg Filmtabletten

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Il-Bulgarija

| Bayer Pharma AG, |
| --- |
| Mullerstrasse 170-178 |
| Berlin |
| 13342 |
| Germany |

Bayer Pharma AG,

Mullerstrasse 170-178

Berlin

13342

Germany

ELOINE

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Ċipru

| Bayer Hellas ABEE |
| --- |
| Sorou 18-20 |
| 151 25 Marousi |
| Greece |

Bayer Hellas ABEE

Sorou 18-20

151 25 Marousi

Greece

LINATERA FC TABLETS

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Ir-Repubblika Ċeka

| Bayer Pharma AG |
| --- |
| Müllerstrasse 178 |
| D-13342 Berlin |
| Germany |

Bayer Pharma AG

Müllerstrasse 178

D-13342 Berlin

Germany

ELOINE 0,02 MG/3 MG POTAHOVANÉ TABLETY

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Id-Danimarka

| Bayer AB |
| --- |
| Gustav III:s Boulevard 56 |
| Postbox 606 |
| SE-16926 Solna |
| Sweden |

Bayer AB

Gustav III:s Boulevard 56

Postbox 606

SE-16926 Solna

Sweden

Eloine

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Il-Finlandja

| Bayer Oy |
| --- |
| Pansiontie 47 |
| PO Box 415 |
| 20101 Turku |
| Finland |

Bayer Oy

Pansiontie 47

PO Box 415

20101 Turku

Finland

Linatera

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Franza

| BAYER SANTE |
| --- |
| 220 avenue de la Recherche |
| 59120 Loos |
| France |

BAYER SANTE

220 avenue de la Recherche

59120 Loos

France

RIMENDIA 0,02 mg/3 mg comprimé pelliculé

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Il-Ġermanja

| Jenapharm GmbH & Co. |
| --- |
| KG Otto-Schott-Str. 15 |
| D-07745 Jena |
| Germany |

Jenapharm GmbH & Co.

KG Otto-Schott-Str. 15

D-07745 Jena

Germany

Eloine 0,02 mg/3 mg Filmtabletten

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Il-Greċja

| BAYER HELLAS ABEE |
| --- |
| Sorou 18-20 |
| Maroussi 15127 |
| Greece |

BAYER HELLAS ABEE

Sorou 18-20

Maroussi 15127

Greece

LINATERA

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

L-Islanda

| Bayer AB |
| --- |
| Gustav III:s Boulevard 56 |
| 169 26 Solna |
| Sweden |

Bayer AB

Gustav III:s Boulevard 56

169 26 Solna

Sweden

Eloine

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

L-Italja

| Bayer S.p.A. |
| --- |
| Viale Certosa 130 |
| Milano 20156 |
| Italy |

Bayer S.p.A.

Viale Certosa 130

Milano 20156

Italy

ELOINE

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Malta

| Bayer plc |
| --- |
| Bayer House |
| Strawberry Hill, Newbury Berkshire, RG14 1JA |
| United Kingdom |

Bayer plc

Bayer House

Strawberry Hill, Newbury Berkshire, RG14 1JA

United Kingdom

ELOINE 0.02 mg/3 mg film coated tablets

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

In-Norveġja

| Bayer AB |
| --- |
| Gustav III's Boulevard 56 |
| 169 26 Solna |
| Sweden |

Bayer AB

Gustav III's Boulevard 56

169 26 Solna

Sweden

Eloine

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Il-Polonja

| Bayer Pharma AG |
| --- |
| Müllerstr. 178, Berlin D-13342 |
| Germany |

Bayer Pharma AG

Müllerstr. 178, Berlin D-13342

Germany

Linatera

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Il-Portugall

| Berlifarma - Especialidades |
| --- |
| Farmacêuticas, Lda. Rua Quinta Pinheiro, 5, |
| Outurela |
| 2794-003 Carnaxide |
| Portugal |

Berlifarma - Especialidades

Farmacêuticas, Lda. Rua Quinta Pinheiro, 5,

Outurela

2794-003 Carnaxide

Portugal

Linatera

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

ls-Slovakkja

| Bayer spol. s r.o. |
| --- |
| Einsteinova 25 |
| 851 01 Bratislava |
| Slovak Republic |

Bayer spol. s r.o.

Einsteinova 25

851 01 Bratislava

Slovak Republic

Linatera

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Is-Slovenja

| Bayer d.o.o. |
| --- |
| Bravničarjeva 13 |
| SI-1000 Ljubljana |
| Slovenia |

Bayer d.o.o.

Bravničarjeva 13

SI-1000 Ljubljana

Slovenia

Linatera 0,02 mg/3 mg filmsko obložene tablete

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Spanja

| BAYHEALTH S.L. |
| --- |
| Avda. Baix Llobregat 3 y 5 |
| 08970 Sant Joan Despi |
| Barcelona |
| Spain |

BAYHEALTH S.L.

Avda. Baix Llobregat 3 y 5

08970 Sant Joan Despi

Barcelona

Spain

ELOINE 0,02 mg/3 mg comprimidos recubiertos con película

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

L-Isvezja

| Bayer AB |
| --- |
| Box 606 |
| SE-16929 Solna |
| Sweden |

Bayer AB

Box 606

SE-16929 Solna

Sweden

Eloine

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

L-Olanda

| Berlipharm BV. |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| The Netherlands |

Berlipharm BV.

Energieweg 1

3641 RT Mijdrecht

The Netherlands

Ethinylestradiol/Drospirenon 24 + 4 0,02 mg/3 mg Berlipharm, filmomhulde tabletten

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

Ir-Renju Unit

| Bayer PLC Bayer House |
| --- |
| Strawberry Hill, Newbury |
| Berkshire RG14 1JA |
| United Kingdom |

Bayer PLC Bayer House

Strawberry Hill, Newbury

Berkshire RG14 1JA

United Kingdom

ELOINE Film-Coated Tablets 0.02 mg/3 mg

0,02 mg/3 mg

Pillola miksija b’rita

Użu orali

---