# Gazzetta ufficiale C 148/2012

| | ISSN 1977-0944
  doi:10.3000/19770944.C_2012.148.ita |
| --- | --- |
| Gazzetta ufficiale
  dell'Unione europea | C 148 |
| | |
| Edizione in lingua italiana | Comunicazioni e informazioni | 55o anno25 maggio 2012 |

ISSN 1977-0944

doi:10.3000/19770944.C_2012.148.ita

Gazzetta ufficiale

dell'Unione europea

C 148

Edizione in lingua italiana

Comunicazioni e informazioni

55o anno25 maggio 2012

---

| Numero d'informazione | Sommario | pagina |
| --- | --- | --- |
| | IV   Informazioni |
| | INFORMAZIONI PROVENIENTI DALLE ISTITUZIONI, DAGLI ORGANI E DAGLI ORGANISMI DELL'UNIONE EUROPEA |
| | Commissione europea |
| 2012/C 148/01 | Sintesi delle decisioni dell'Unione europea relative alle autorizzazioni all'immissione in commercio di medicinali dal 1 aprile 2012 al 30 aprile 2012(pubblicate a norma dell'articolo 13 o dell'articolo 38 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio) | 1 |
| 2012/C 148/02 | Sintesi delle decisioni dell'Unione europea relative alle autorizzazioni all'immissione in commercio di medicinali dal 1 aprile 2012 al 30 aprile 2012(decisioni adottate in forza delle disposizioni dell'articolo 34 della direttiva 2001/83/CE o dell'articolo 38 della direttiva 2001/82/CE) | 12 |

Numero d'informazione

Sommario

pagina

IV   Informazioni

INFORMAZIONI PROVENIENTI DALLE ISTITUZIONI, DAGLI ORGANI E DAGLI ORGANISMI DELL'UNIONE EUROPEA

Commissione europea

2012/C 148/01

Sintesi delle decisioni dell'Unione europea relative alle autorizzazioni all'immissione in commercio di medicinali dal 1 aprile 2012 al 30 aprile 2012(pubblicate a norma dell'articolo 13 o dell'articolo 38 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio)

(pubblicate a norma dell'articolo 13 o dell'articolo 38 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio)

1

2012/C 148/02

Sintesi delle decisioni dell'Unione europea relative alle autorizzazioni all'immissione in commercio di medicinali dal 1 aprile 2012 al 30 aprile 2012(decisioni adottate in forza delle disposizioni dell'articolo 34 della direttiva 2001/83/CE o dell'articolo 38 della direttiva 2001/82/CE)

(decisioni adottate in forza delle disposizioni dell'articolo 34 della direttiva 2001/83/CE o dell'articolo 38 della direttiva 2001/82/CE)

12

| IT | |
| --- | --- |

IT

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IV Informazioni

INFORMAZIONI PROVENIENTI DALLE ISTITUZIONI, DAGLI ORGANI E DAGLI ORGANISMI DELL'UNIONE EUROPEA

Commissione europea

| 25.5.2012 | IT | Gazzetta ufficiale dell'Unione europea | C 148/1 |
| --- | --- | --- | --- |

25.5.2012

IT

Gazzetta ufficiale dell'Unione europea

C 148/1

---

Sintesi delle decisioni dell'Unione europea relative alle autorizzazioni all'immissione in commercio di medicinali dal 1 aprile 2012 al 30 aprile 2012

(pubblicate a norma dell'articolo 13 o dell'articolo 38 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio
   (1)
  )

2012/C 148/01

—   Rilascio di un'autorizzazione all'immissione in commercio (articolo 13 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio): Accettate

| Data della decisione | Denominazione del medicinale | DCI (denominazione comune internazionale) | Titolare dell'autorizzazione all'immissione in commercio | Numero d'iscrizione nel registro comunitario | Forma farmaceutica | Codice ATC (anatomico, terapeutico e chimico) | Data di notifica |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.4.2012 | Bronchitol | Mannitolo | Pharmaxis Pharmaceuticals Limited |
| The Priory, Stomp Road, Burnham, |
| Buckinghamshire, |
| SL1 7LW, |
| United Kingdom |

Data della decisione

Denominazione del medicinale

DCI (denominazione comune internazionale)

Titolare dell'autorizzazione all'immissione in commercio

Numero d'iscrizione nel registro comunitario

Forma farmaceutica

Codice ATC (anatomico, terapeutico e chimico)

Data di notifica

13.4.2012

Bronchitol

Mannitolo

Pharmaxis Pharmaceuticals Limited

The Priory, Stomp Road, Burnham,

Buckinghamshire,

SL1 7LW,

United Kingdom

EU/1/12/760/001-002

Polvere per inalazione, capsule rigide

R05CB16

18.4.2012

13.4.2012

Sabervel

Irbesartan

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

Pharmathen S.A.

6 Dervenakion,

15351 Pallini Attiki,

Ελλάδα

EU/1/12/765/001-006

Compressa rivestita con film

C09CA04

17.4.2012

20.4.2012

Capecitabine Accord

capecitabina

| Accord Healthcare Limited |
| --- |
| Sage house, 319 Pinner road, North Harrow, |
| Middlesex |
| HA1 4HF |
| United Kingdom |

Accord Healthcare Limited

Sage house, 319 Pinner road, North Harrow,

Middlesex

HA1 4HF

United Kingdom

EU/1/12/762/001-018

Compressa rivestita con film

L01BC06

25.4.2012

20.4.2012

Capecitabine Krka

capecitabina

| KRKA, d.d |
| --- |
| Novo mesto, Šmarješka cesta 6, |
| 8501 Novo mesto, |
| Slovenia |

KRKA, d.d

Novo mesto, Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

EU/1/12/763/001-018

Compressa rivestita con film

L01BC06

25.4.2012

20.4.2012

Capecitabine Teva

capecitabina

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

TEVA Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/12/761/001-002

Compressa rivestita con film

L01BC06

25.4.2012

20.4.2012

Nimenrix

Vaccino coniugato meningococcico gruppo A, C, W-135 e Y

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89, |
| 1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/12/767/001-007

Polvere e solvente per soluzione iniettabile

J07AH08

25.4.2012

20.4.2012

SANCUSO

Granisetron

| ProStrakan Limited |
| --- |
| Galabank Business Park, |
| Galashiels, |
| TD1 1QH, |
| United Kingdom |

ProStrakan Limited

Galabank Business Park,

Galashiels,

TD1 1QH,

United Kingdom

EU/1/12/766/001

Cerotto transdermico

A04AA02

25.4.2012

20.4.2012

Zoledronic acid Actavis

Acido zoledronico

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

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78,

Hafnarfjörður 220,

Iceland

EU/1/12/759/001-003

Concentrato per soluzione per infusione

M05BA08

26.4.2012

24.4.2012

Signifor

pasireotide

| 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/1/12/753/001-012

Soluzione iniettabile

H01CB05

27.4.2012

—   Modifica di un'autorizzazione all'immissione in commercio (articolo 13 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio): Accettate

| Data della decisione | Denominazione del medicinale | Titolare dell'autorizzazione all'immissione in commercio | Numero d'iscrizione nel registro comunitario | Data di notifica |
| --- | --- | --- | --- | --- |
| 3.4.2012 | Kinzalkomb | Bayer Pharma AG |
| 13342, Berlin |
| Deutschland |

Data della decisione

Denominazione del medicinale

Titolare dell'autorizzazione all'immissione in commercio

Numero d'iscrizione nel registro comunitario

Data di notifica

3.4.2012

Kinzalkomb

Bayer Pharma AG

13342, Berlin

Deutschland

EU/1/02/214/001-015

5.4.2012

4.4.2012

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

10.4.2012

4.4.2012

Plavix

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174 avenue de France – |
| 75013 Paris, |
| France |

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France –

75013 Paris,

France

EU/1/98/069/001a-001b

EU/1/98/069/002a-002b

EU/1/98/069/003a-003b

EU/1/98/069/004a-004b

EU/1/98/069/005a-005b

EU/1/98/069/006a-006b

EU/1/98/069/007a-007b

EU/1/98/069/008-010

EU/1/98/069/011a-011b

EU/1/98/069/012

11.4.2012

4.4.2012

Rebetol

| Schering Plough Europe |
| --- |
| Clos du Lynx 5, |
| 1200 Bruxelles, |
| Belgique – |

Schering Plough Europe

Clos du Lynx 5,

1200 Bruxelles,

Belgique –

| Lynx Binnenhof 5, |
| --- |
| 1200 Brussel, |
| België |

Lynx Binnenhof 5,

1200 Brussel,

België

EU/1/99/107/001-005

11.4.2012

4.4.2012

Telzir

| 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/1/04/282/001-002

11.4.2012

10.4.2012

Vedrop

| Orphan Europe SARL |
| --- |
| Immeuble Le Wilson – |
| 70 Avenue du Général de Gaulle – |
| F 92 800 Puteaux – |
| France |

Orphan Europe SARL

Immeuble Le Wilson –

70 Avenue du Général de Gaulle –

F 92 800 Puteaux –

France

EU/1/09/533/001-003

12.4.2012

13.4.2012

Advagraf

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, |
| NL-2353 EW Leiderdorp, |
| Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19,

NL-2353 EW Leiderdorp,

Nederland

EU/1/07/387/001-026

17.4.2012

13.4.2012

alli

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

Glaxo Group Limited

Glaxo Wellcome House, Berkeley Avenue, Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/07/401/007-016

17.4.2012

13.4.2012

Champix

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, |
| Kent |
| CT 13 9NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/06/360/001-013

17.4.2012

13.4.2012

Evoltra

| Genzyme Europe BV |
| --- |
| Gooimeer 10, |
| 1411 DD Naarden, |
| Nederland |

Genzyme Europe BV

Gooimeer 10,

1411 DD Naarden,

Nederland

EU/1/06/334/001-005

17.4.2012

13.4.2012

Foscan

| Biolitec pharma Ltd |
| --- |
| United Drug House, Magna Drive, |
| Dublin 24, |
| Ireland |

Biolitec pharma Ltd

United Drug House, Magna Drive,

Dublin 24,

Ireland

EU/1/01/197/003-005

17.4.2012

13.4.2012

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/1/08/442/001-014

17.4.2012

13.4.2012

Prometax

| 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/1/98/092/001-026

17.4.2012

13.4.2012

Revatio

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

Pfizer Limited

Sandwich,

Kent,

CT13 9NJ,

United Kingdom

EU/1/05/318/001

17.4.2012

13.4.2012

Revlimid

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

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge,

Middlesex,

UB11 1DB,

United Kingdom

EU/1/07/391/001-004

17.4.2012

13.4.2012

Soliris

| Alexion Europe S.A.S. |
| --- |
| 25, boulevard de l'Amiral Bruix, |
| 75016 Paris, |
| France |

Alexion Europe S.A.S.

25, boulevard de l'Amiral Bruix,

75016 Paris,

France

EU/1/07/393/001

17.4.2012

13.4.2012

Tyverb

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

Glaxo Group Limited

Berkeley Avenue, Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/07/440/001-006

17.4.2012

13.4.2012

Viramune

| 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/1/97/055/001-009

17.4.2012

13.4.2012

Volibris

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

Glaxo Group Ltd

Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/08/451/001-004

17.4.2012

20.4.2012

Abraxane

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

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge,

Middlesex,

UB11 1DB,

United Kingdom

EU/1/07/428/001

24.4.2012

20.4.2012

Aclasta

| 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/1/05/308/001-002

25.4.2012

20.4.2012

Aflunov

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, |
| 53100 Siena, |
| Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/658/001-002

26.4.2012

20.4.2012

Altargo

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

Glaxo Group Limited

Glaxo Wellcome House, Berkeley Avenue, Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/07/390/001-004

26.4.2012

20.4.2012

Apidra

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/04/285/001-036

26.4.2012

20.4.2012

Ceplene

| EpiCept GmbH |
| --- |
| Goethestrasse 4, |
| D-80336 München, |
| Deutschland |

EpiCept GmbH

Goethestrasse 4,

D-80336 München,

Deutschland

EU/1/08/477/001

24.4.2012

20.4.2012

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/1/07/392/001-003

25.4.2012

20.4.2012

Exelon

| 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/1/98/066/001-026

26.3.2012

20.4.2012

Focetria

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, |
| 53100 Siena, |
| Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/07/385/001-002

EU/1/07/385/004

26.4.2012

20.4.2012

HALAVEN

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

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield,

Herts

AL10 9SN,

United Kingdom

EU/1/11/678/001-002

25.4.2012

20.4.2012

Helixate NexGen

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

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/00/144/001-005

25.4.2012

20.4.2012

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/1/03/256/002-010

25.4.2012

20.4.2012

Insulin Human Winthrop

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/06/368/001-015

EU/1/06/368/020-024

EU/1/06/368/029-033

EU/1/06/368/037-042

EU/1/06/368/047-051

EU/1/06/368/056-057

EU/1/06/368/088-102

EU/1/06/368/113-150

EU/1/06/368/163-168

25.4.2012

20.4.2012

Insuman

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/97/030/028-195

26.4.2012

20.4.2012

IOA

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

N.V. Organon

Kloosterstraat 6,

5349 AB Oss,

Nederland

EU/1/11/689/001-002

24.4.2012

20.4.2012

Iressa

| AstraZeneca AB |
| --- |
| S 151 85 Sodertalje, |
| Sverige |

AstraZeneca AB

S 151 85 Sodertalje,

Sverige

EU/1/09/526/001-002

26.4.2012

20.4.2012

Kogenate Bayer

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

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/00/143/004-013

25.4.2012

20.4.2012

Lantus

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/00/134/001-037

25.4.2012

20.4.2012

Norvir

| 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/1/96/016/001

EU/1/96/016/003-008

26.4.2012

20.4.2012

NovoNorm

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/98/076/004-006

EU/1/98/076/011-013

EU/1/98/076/018-020

EU/1/98/076/022-024

26.3.2012

20.4.2012

Opgenra

| Olympus Biotech International Limited |
| --- |
| Raheen Business Park, Limerick, |
| Ireland |

Olympus Biotech International Limited

Raheen Business Park, Limerick,

Ireland

EU/1/08/489/001-002

24.4.2012

20.4.2012

Optimark

| Covidien Deutschland GmbH |
| --- |
| Gewerbepark 1, |
| 93333, Neustadt/Donau |
| Deutschland |

Covidien Deutschland GmbH

Gewerbepark 1,

93333, Neustadt/Donau

Deutschland

EU/1/07/398/001-014

26.3.2012

20.4.2012

Optisulin

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/00/133/001-032

25.4.2012

20.4.2012

Pelzont

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon,

Hertfordshire

EN11 9BU,

United Kingdom

EU/1/08/460/001-014

25.4.2012

20.4.2012

Prandin

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/00/162/003-005

EU/1/00/162/009-011

EU/1/00/162/015-017

EU/1/00/162/019-021

26.4.2012

20.4.2012

Preotact

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1, |
| DK-4000 Roskilde, |
| Danmark |

Nycomed Danmark ApS

Langebjerg 1,

DK-4000 Roskilde,

Danmark

EU/1/06/339/001-003

25.4.2012

20.4.2012

Prolia

| Amgen Europe B.V. |
| --- |
| Minervum 7061, |
| NL-4817 ZK Breda, |
| Nederland |

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/10/618/001-004

24.4.2012

20.4.2012

ProQuad

| Sanofi Pasteur MSD, SNC |
| --- |
| 8, rue Jonas Salk, |
| 69007 Lyon, |
| France |

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/05/323/001-013

26.4.2012

20.4.2012

Rasilamlo

| 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/1/11/686/001-056

24.4.2012

20.4.2012

Rasilez

| 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/1/07/405/001-040

24.4.2012

20.4.2012

Riprazo

| 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/1/07/409/001-040

24.4.2012

20.4.2012

Riprazo 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/1/11/680/001-080

24.4.2012

20.4.2012

Samsca

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, |
| Middlesex |
| UB8 1LX, |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park, Oxford Road, Uxbridge,

Middlesex

UB8 1LX,

United Kingdom

EU/1/09/539/001-004

24.4.2012

20.4.2012

Sebivo

| 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/1/07/388/001-003

26.4.2012

20.4.2012

Silodyx

| Recordati Ireland Ltd. |
| --- |
| Raheens East, Ringaskiddy Co. Cork, |
| Ireland |

Recordati Ireland Ltd.

Raheens East, Ringaskiddy Co. Cork,

Ireland

EU/1/09/607/001-014

24.4.2012

20.4.2012

Sprimeo

| 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/1/07/407/001-040

24.4.2012

20.4.2012

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

24.4.2012

20.4.2012

Tracleer

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor, 389 Chiswick High Road, |
| London |
| W4 4AL, |
| United Kingdom |

Actelion Registration Ltd

BSI Building 13th Floor, 389 Chiswick High Road,

London

W4 4AL,

United Kingdom

EU/1/02/220/001-006

26.4.2012

20.4.2012

Tredaptive

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon,

Hertfordshire

EN11 9BU,

United Kingdom

EU/1/08/459/001-014

25.4.2012

20.4.2012

Trevaclyn

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon,

Hertfordshire

EN11 9BU,

United Kingdom

EU/1/08/458/001-014

25.4.2012

20.4.2012

Urorec

| Recordati Ireland Ltd. |
| --- |
| Raheens East, Ringaskiddy Co. Cork, |
| Ireland |

Recordati Ireland Ltd.

Raheens East, Ringaskiddy Co. Cork,

Ireland

EU/1/09/608/001-014

24.4.2012

20.4.2012

Ventavis

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

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/03/255/001-008

26.4.2012

20.4.2012

Vfend

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, |
| Kent |
| CT 13 9NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/02/212/001-026

25.4.2012

20.4.2012

Victoza

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

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/09/529/001-005

24.4.2012

20.4.2012

Vidaza

| Celgene Europe Ltd |
| --- |
| 1 Longwalk Road, Stockley Park, |
| Uxbridge, |
| UB11 1DB, |
| United Kingdom |

Celgene Europe Ltd

1 Longwalk Road, Stockley Park,

Uxbridge,

UB11 1DB,

United Kingdom

EU/1/08/488/001

24.4.2012

20.4.2012

Xenical

| 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/1/98/071/001-006

24.4.2012

20.4.2012

Yttriga

| Eckert & Ziegler Radiopharma GmbH |
| --- |
| Robert-Rössle-Str. 10, |
| 13125 Berlin |
| Deutschland |

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Str. 10,

13125 Berlin

Deutschland

EU/1/05/322/001-002

26.4.2012

20.4.2012

Zoely

| Theramex S.r.l. |
| --- |
| Via Messina 38, |
| 20154 Milano, |
| Italia |

Theramex S.r.l.

Via Messina 38,

20154 Milano,

Italia

EU/1/11/690/001-002

24.4.2012

24.4.2012

Menveo

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, |
| 53100 Siena, |
| Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1,

53100 Siena,

Italia

EU/1/10/614/001-003

27.4.2012

24.4.2012

Rasilez HCT

| 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/1/08/491/001-080

27.4.2012

24.4.2012

Temomedac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Fehlandtstrasse 3, |
| D-20354 Hamburg – |
| Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstrasse 3,

D-20354 Hamburg –

Deutschland

EU/1/09/605/001-012

27.4.2012

26.4.2012

Revolade

| 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/1/10/612/001-006

30.4.2012

26.4.2012

Yervoy

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park, Sanderson Road, |
| Uxbridge |
| UB8 1DH, |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road,

Uxbridge

UB8 1DH,

United Kingdom

EU/1/11/698/001-002

30.4.2012

—   Ritiro di un'autorizzazione all'immissione in commercio (articolo 13 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio)

| Data della decisione | Denominazione del medicinale | Titolare dell'autorizzazione all'immissione in commercio | Numero d'iscrizione nel registro comunitario | Data di notifica |
| --- | --- | --- | --- | --- |
| 20.4.2012 | PhotoBarr | Pinnacle Biologics B.V. |
| p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, |
| 1043 DP Amsterdam, |
| Nederland |

Data della decisione

Denominazione del medicinale

Titolare dell'autorizzazione all'immissione in commercio

Numero d'iscrizione nel registro comunitario

Data di notifica

20.4.2012

PhotoBarr

Pinnacle Biologics B.V.

p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10,

1043 DP Amsterdam,

Nederland

EU/1/04/272/001-002

25.4.2012

24.4.2012

Refludan

| Celgene Europe Ltd |
| --- |
| 1 Longwalk Road, Stockley Park, |
| Uxbridge, |
| UB11 1DB, |
| United Kingdom |

Celgene Europe Ltd

1 Longwalk Road, Stockley Park,

Uxbridge,

UB11 1DB,

United Kingdom

EU/1/97/035/001-004

27.4.2012

—   Modifica di un'autorizzazione all'immissione in commercio (articolo 38 del regolamento (CE) n. 726/2004 del Parlamento europeo e del Consiglio): Accettate

| Data della decisione | Denominazione del medicinale | Titolare dell'autorizzazione all'immissione in commercio | Numero d'iscrizione nel registro comunitario | Data di notifica |
| --- | --- | --- | --- | --- |
| 10.4.2012 | Slentrol | Pfizer Ltd |
| Ramsgate Road, Sandwich, |
| Kent |
| CT 13 9NJ, |
| United Kingdom |

Data della decisione

Denominazione del medicinale

Titolare dell'autorizzazione all'immissione in commercio

Numero d'iscrizione nel registro comunitario

Data di notifica

10.4.2012

Slentrol

Pfizer Ltd

Ramsgate Road, Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/2/07/071/001-003

12.4.2012

13.4.2012

Cerenia

| Pfizer Ltd |
| --- |
| Ramsgate Road, Sandwich, |
| Kent |
| CT 13 9NJ, |
| United Kingdom |

Pfizer Ltd

Ramsgate Road, Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/2/06/062/005

17.4.2012

20.4.2012

BTVPUR AlSap 1

| MERIAL |
| --- |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/112/001-005

25.4.2012

20.4.2012

BTVPUR AlSap 1-8

| MERIAL |
| --- |
| 29 avenue Tony Garnier, |
| 69007 LYON, |
| France |

MERIAL

29 avenue Tony Garnier,

69007 LYON,

France

EU/2/10/113/001-005

25.4.2012

20.4.2012

Loxicom

| Norbrook Laboratories Limited |
| --- |
| Station Works, Newry, |
| Co. Down, |
| BT35 6JP, |
| United Kindgom |

Norbrook Laboratories Limited

Station Works, Newry,

Co. Down,

BT35 6JP,

United Kindgom

EU/2/08/090/001-027

24.4.2012

20.4.2012

Meloxivet

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30, |
| B-2340 Beerse, |
| België |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/2/07/077/001-005

25.4.2012

Per consultare la relazione pubblica di valutazione sui medicinali in questione e le correlate decisioni contattare:

| 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)  GU L 136 del 30.4.2004, pag. 1.

---

| 25.5.2012 | IT | Gazzetta ufficiale dell'Unione europea | C 148/12 |
| --- | --- | --- | --- |

25.5.2012

IT

Gazzetta ufficiale dell'Unione europea

C 148/12

---

Sintesi delle decisioni dell'Unione europea relative alle autorizzazioni all'immissione in commercio di medicinali dal 1 aprile 2012 al 30 aprile 2012

(decisioni adottate in forza delle disposizioni dell'articolo 34 della direttiva 2001/83/CE
   (1)
  o dell'articolo 38 della direttiva 2001/82/CE
   (2)
  )

2012/C 148/02

—   Rilascio, conservazione o modifica di una autorizzazione nazionale all’immissione in commercio

| Data della decisione | Denominazione o denominazioni del medicinale | Titolare o titolari dell'autorizzazione all'immissione in commercio | Stato membro in questione | Data di notifica |
| --- | --- | --- | --- | --- |
| 24.4.2012 | Orlistat | Cfr. Allegato I | Cfr. Allegato I | 26.4.2012 |

Data della decisione

Denominazione o denominazioni del medicinale

Titolare o titolari dell'autorizzazione all'immissione in commercio

Stato membro in questione

Data di notifica

24.4.2012

Orlistat

Cfr. Allegato I

Cfr. Allegato I

26.4.2012

---

(1)  GU L 311 del 28.11.2001, pag. 67.

(2)  GU L 311 del 28.11.2001, pag. 1.

---

ALLEGATO I

ELENCO DEI NOMI DEI MEDICINALI, DELLE FORME FARMACEUTICHE, DEI DOSAGGI, DELLE VIE DI SOMMINISTRAZIONE, DEI TITOLARI DELL’ AUTORIZZAZIONE ALL’IMMISSIONE IN COMMERCIO NEGLI STATI MEMBRI

| Stato membro UE/SEE | Titolare dell’autorizzazione all’immissione in commercio | Nome di fantasia Nome | Dosaggio | Forma farmaceutica | Via di somministrazione |
| --- | --- | --- | --- | --- | --- |
| Belgio | Eurogenerics NV |
| Heizel Esplanade b22 |
| 1020 Brussel |
| Belgium |

Stato membro UE/SEE

Titolare dell’autorizzazione all’immissione in commercio

Nome di fantasia Nome

Dosaggio

Forma farmaceutica

Via di somministrazione

Belgio

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Orlistat EG

60 mg

Capsula rigida

Uso orale

Belgio

| Eurogenerics NV |
| --- |
| Heizel Esplanade b22 |
| 1020 Brussel |
| Belgium |

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Orlistat EG

120 mg

Capsula rigida

Uso orale

Belgio

| Pharmaceuticals Works Pharma SA |
| --- |
| 19, Pelplinska street |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceuticals Works Pharma SA

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

60 mg

Capsula rigida

Uso orale

Belgio

| Pharmaceuticals Works Pharma SA |
| --- |
| 19, Pelplinska street |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceuticals Works Pharma SA

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

120 mg

Capsula rigida

Uso orale

Belgio

| Sandoz NV/SA |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| B-Vilvoorde |
| Belgium |

Sandoz NV/SA

Telecom Gardens

Medialaan 40

B-Vilvoorde

Belgium

Orlistat Sandoz

60 mg

Capsula rigida

Uso orale

Belgio

| Sandoz NV/SA |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| B-Vilvoorde |
| Belgium |

Sandoz NV/SA

Telecom Gardens

Medialaan 40

B-Vilvoorde

Belgium

Orlistat Sandoz

120 mg

Capsula rigida

Uso orale

Bulgaria

| Pharmaceutical Works Polpharma S.A |
| --- |
| 19, Peplinska Street |
| 83-200 Starogar Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A

19, Peplinska Street

83-200 Starogar Gdanski

Poland

Orlistat Polpharma

60 mg

Capsula rigida

Uso orale

Bulgaria

| Pharmaceutical Works Polpharma S.A |
| --- |
| 19, Peplinska Street |
| 83-200 Starogar Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A

19, Peplinska Street

83-200 Starogar Gdanski

Poland

Orlistat Polpharma

120 mg

Capsula rigida

Uso orale

Bulgaria

| Teva Pharmaceuticals Bulgaria EOOD |
| --- |
| 15 N.V Gogol Str. |
| 1124 Sofia |
| Bulgaria |

Teva Pharmaceuticals Bulgaria EOOD

15 N.V Gogol Str.

1124 Sofia

Bulgaria

Orlistat Teva

60 mg

Capsula rigida

Uso orale

Bulgaria

| Teva Pharmaceuticals Bulgaria EOOD |
| --- |
| 15 N.V Gogol Str. |
| 1124 Sofia |
| Bulgaria |

Teva Pharmaceuticals Bulgaria EOOD

15 N.V Gogol Str.

1124 Sofia

Bulgaria

Orlistat Teva

120 mg

Capsula rigida

Uso orale

Repubblica Ceca

| Sandoz s.r.o |
| --- |
| U Nákladového nádraží 10 |
| CZ-130 00, Praha 3, |
| Czech Republic |

Sandoz s.r.o

U Nákladového nádraží 10

CZ-130 00, Praha 3,

Czech Republic

Orlistat Sandoz 60 mg

60 mg

Capsula rigida

Uso orale

Repubblica Ceca

| Sandoz s.r.o |
| --- |
| U Nákladového nádraží 10 |
| CZ-130 00, Praha 3, |
| Czech Republic |

Sandoz s.r.o

U Nákladového nádraží 10

CZ-130 00, Praha 3,

Czech Republic

Orlistat Sandoz 120 mg

120 mg

Capsula rigida

Uso orale

Repubblica Ceca

| Teva Pharmaceuticals CR s.r.o. |
| --- |
| Radlická 3185/1c |
| 150 00 Prague |
| Czech Republic |

Teva Pharmaceuticals CR s.r.o.

Radlická 3185/1c

150 00 Prague

Czech Republic

Orlistat Teva 60 mg

60 mg

Capsula rigida

Uso orale

Repubblica Ceca

| Teva Pharmaceuticals CR s.r.o. |
| --- |
| Radlická 3185/1c |
| 150 00 Prague |
| Czech Republic |

Teva Pharmaceuticals CR s.r.o.

Radlická 3185/1c

150 00 Prague

Czech Republic

Orlistat Teva 120 mg

120 mg

Capsula rigida

Uso orale

Danimarca

| Sandoz A/S, |
| --- |
| Edvard Thomsens Vej 14, |
| DK-2300 Copenhagen S, |
| Denmark |

Sandoz A/S,

Edvard Thomsens Vej 14,

DK-2300 Copenhagen S,

Denmark

Orlistat "Sandoz"

60 mg

Capsula rigida

Uso orale

Danimarca

| Teva Denmark A/S, |
| --- |
| Parallelvej 10-12, |
| DK-2800 Kongens Lyngby, |
| Denmark |

Teva Denmark A/S,

Parallelvej 10-12,

DK-2800 Kongens Lyngby,

Denmark

Orlistat "Teva"

60 mg

Capsula rigida

Uso orale

Danimarca

| Teva Denmark A/S, |
| --- |
| Parallelvej 10-12, |
| DK-2800 Kongens Lyngby, |
| Denmark |

Teva Denmark A/S,

Parallelvej 10-12,

DK-2800 Kongens Lyngby,

Denmark

Orlistat "Teva"

120 mg

Capsula rigida

Uso orale

Estonia

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

ORLISTAT TEVA 60 MG

60 mg

Capsula rigida

Uso orale

Estonia

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

ORLISTAT TEVA 120 MG

120 mg

Capsula rigida

Uso orale

Estonia

| Pharmaceutical Works Polpharma S.A. |
| --- |
| 19 Pelplinska Str. |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

ORLISTAT POLPHARMA 60 MG

60 mg

Capsula rigida

Uso orale

Estonia

| Pharmaceutical Works Polpharma S.A. |
| --- |
| 19 Pelplinska Str. |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A.

19 Pelplinska Str.

83-200 Starogard Gdanski

Poland

ORLISTAT POLPHARMA 120 MG

120 mg

Capsula rigida

Uso orale

Estonia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

ORLISTAT SANDOZ 60 MG

60 mg

Capsula rigida

Uso orale

Estonia

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI-1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

ORLISTAT SANDOZ 120 MG

120 mg

Capsula rigida

Uso orale

Finlandia

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Orlistat ratiopharm

120 mg

Capsula rigida

Uso orale

Finlandia

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Orlistat ratiopharm

60 mg

Capsula rigida

Uso orale

Finlandia

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| Copenhagen S 2300 |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

Copenhagen S 2300

Denmark

Orlistat Sandoz

60 mg

Capsula rigida

Uso orale

Finlandia

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2 - 18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Orlistat Stada

120 mg

Capsula rigida

Uso orale

Finlandia

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2 - 18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

Orlistat Stada

60 mg

Capsula rigida

Uso orale

Francia

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

ORLISTAT SANDOZ 120 mg, gélule

120 mg

Capsula rigida

Uso orale

Francia

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

ORLISTAT SANDOZ 60 mg, gélule

60 mg

Capsula rigida

Uso orale

Francia

| EG LABO - Laboratoires EuroGenerics |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - Laboratoires EuroGenerics

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

ORLISTAT EG 120 mg, gélule

120 mg

Capsula rigida

Uso orale

Francia

| EG LABO - Laboratoires EuroGenerics |
| --- |
| "Le Quintet" - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - Laboratoires EuroGenerics

"Le Quintet" - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

ORLISTAT EG 60 mg, gélule

60 mg

Capsula rigida

Uso orale

Francia

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

ORLISTAT TEVA 120 mg, gélule

120 mg

Capsula rigida

Uso orale

Francia

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

ORLISTAT TEVA 60 mg, gélule

60 mg

Capsula rigida

Uso orale

Germania

| Aliud Pharma GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |
| Germany |

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Germany

Orlistat AL 60 mg Hartkapseln

60 mg

Capsula rigida

Uso orale

Germania

| HEXAL Aktiengesellschaft |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL Aktiengesellschaft

Industriestr. 25

D-83607 Holzkirchen

Germany

Orlistat HEXAL 120 mg Hartkapseln

120 mg

Capsula rigida

Uso orale

Germania

| HEXAL Aktiengesellschaft |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL Aktiengesellschaft

Industriestr. 25

D-83607 Holzkirchen

Germany

Orlistat HEXAL 60 mg Hartkapseln

60 mg

Capsula rigida

Uso orale

Germania

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Orlistat-ratiopharm 120 mg Hartkapseln

120 mg

Capsula rigida

Uso orale

Germania

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Orlistat-ratiopharm 60 mg Hartkapseln

60 mg

Capsula rigida

Uso orale

Italia

| EG S.P.A. |
| --- |
| Via Scarlatti, 31 |
| 20124 Milano |
| Italy |

EG S.P.A.

Via Scarlatti, 31

20124 Milano

Italy

ORLSTAT EUROGENERICI

60 mg

Capsula rigida

Uso orale

Italia

| EG S.P.A. |
| --- |
| Via Scarlatti, 31 |
| 20124 Milano |
| Italy |

EG S.P.A.

Via Scarlatti, 31

20124 Milano

Italy

ORLISTAT EG

120 mg

Capsula rigida

Uso orale

Lettonia

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| SI-1000 Ljubljana, |
| Slovenia |

Sandoz d.d.,

Verovškova 57,

SI-1000 Ljubljana,

Slovenia

Orlistat Sandoz

60 mg

Capsula rigida

Uso orale

Lettonia

| Sandoz d.d., |
| --- |
| Verovškova 57, |
| SI-1000 Ljubljana, |
| Slovenia |

Sandoz d.d.,

Verovškova 57,

SI-1000 Ljubljana,

Slovenia

Orlistat Sandoz

120 mg

Capsula rigida

Uso orale

Lettonia

| Pharmaceutical Works POLPHARMA SA, |
| --- |
| 19 Pelplińska Street, |
| 83-200 Starogard Gdański, |
| Poland |

Pharmaceutical Works POLPHARMA SA,

19 Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

60 mg

Capsula rigida

Uso orale

Lettonia

| Pharmaceutical Works POLPHARMA SA, |
| --- |
| 19 Pelplińska Street, |
| 83-200 Starogard Gdański, |
| Poland |

Pharmaceutical Works POLPHARMA SA,

19 Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

120 mg

Capsula rigida

Uso orale

Lettonia

| Teva Pharma B.V., |
| --- |
| Computerweg 10, |
| 3542DR Utrecht, |
| The Netherlands |

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

60 mg

Capsula rigida

Uso orale

Lettonia

| Teva Pharma B.V., |
| --- |
| Computerweg 10, |
| 3542DR Utrecht, |
| The Netherlands |

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

120 mg

Capsula rigida

Uso orale

Lituania

| Teva Pharma B.V., |
| --- |
| Computerweg 10, |
| 3542DR Utrecht, |
| the Netherlands |

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

the Netherlands

Orlistat Teva

60 mg

Capsula rigida

Uso orale

Lituania

| Teva Pharma B.V., |
| --- |
| Computerweg 10, |
| 3542DR Utrecht, |
| The Netherlands |

Teva Pharma B.V.,

Computerweg 10,

3542DR Utrecht,

The Netherlands

Orlistat Teva

120 mg

Capsula rigida

Uso orale

Lituania

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| SI-1000 Ljubljana |
| Slovėnia |

Sandoz d.d.

Verovškova 57

SI-1000 Ljubljana

Slovėnia

Orlistat Sandoz

120 mg

Capsula rigida

Uso orale

Lituania

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| SI-1000 Ljubljana |
| Slovėnia |

Sandoz d.d.

Verovškova 57

SI-1000 Ljubljana

Slovėnia

Orlistat Sandoz

60 mg

Capsula rigida

Uso orale

Lituania

| Pharmaceutical Works POLPHARMA S.A., |
| --- |
| 19 Pelplinska Street, |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works POLPHARMA S.A.,

19 Pelplinska Street,

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

60 mg

Capsula rigida

Uso orale

Lituania

| Pharmaceutical Works POLPHARMA S.A., |
| --- |
| 19 Pelplinska Street, |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works POLPHARMA S.A.,

19 Pelplinska Street,

83-200 Starogard Gdanski

Poland

Orlistat Polpharma

120 mg

Capsula rigida

Uso orale

Norvegia

| Teva Sweden AB |
| --- |
| Järnvägsgatan 11, |
| Box 1070, |
| 251 10 Helsingborg |
| Sweden |

Teva Sweden AB

Järnvägsgatan 11,

Box 1070,

251 10 Helsingborg

Sweden

Orlistat Teva

60 mg

Capsula rigida

Uso orale

Norvegia

| Teva Sweden AB |
| --- |
| Järnvägsgatan 11, |
| Box 1070, |
| 251 10 Helsingborg |
| Sweden |

Teva Sweden AB

Järnvägsgatan 11,

Box 1070,

251 10 Helsingborg

Sweden

Orlistat Teva

120 mg

Capsula rigida

Uso orale

Norvegia

| Sandoz A/S, |
| --- |
| Edvard Thomsens Vej 14, |
| 2300 København S, |
| Denmark |

Sandoz A/S,

Edvard Thomsens Vej 14,

2300 København S,

Denmark

Orlistat Sandoz

60 mg

Capsula rigida

Uso orale

Polonia

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19, Pelplińska Street |
| 83-200 Starogard Gdański |
| Poland |

Pharmaceutical Works POLPHARMA SA

19, Pelplińska Street

83-200 Starogard Gdański

Poland

Orlistat Polpharma 120 mg

120 mg

Capsula rigida

Uso orale

Polonia

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl, |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl,

Austria

Orlistat Sandoz 120 mg

120 mg

Capsula rigida

Uso orale

Polonia

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| D-61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Orlistat STADA 120 mg

120 mg

Capsula rigida

Uso orale

Polonia

| Teva Pharmaceuticals Polska Sp. z o.o. |
| --- |
| ul. Emilii Plater 53 |
| 00-113 Warszawa |
| Poland |

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warszawa

Poland

Orlistat Teva 120 mg

120 mg

Capsula rigida

Uso orale

Polonia

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19, Pelplińska Street |
| 83-200 Starogard Gdański |
| Poland |

Pharmaceutical Works POLPHARMA SA

19, Pelplińska Street

83-200 Starogard Gdański

Poland

Orlistat Polpharma 60 mg

60 mg

Capsula rigida

Uso orale

Polonia

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl, |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl,

Austria

Orlistat Sandoz 60 mg

60 mg

Capsula rigida

Uso orale

Polonia

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| D-61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Orlistat STADA 60 mg

60 mg

Capsula rigida

Uso orale

Portogallo

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B |
| 2770-229 Paço de Arcos |
| Portugal |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos

Portugal

Orlistato Ciclum

60 mg

Capsula rigida

Uso orale

Portogallo

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B |
| 2770-229 Paço de Arcos |
| Portugal |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B

2770-229 Paço de Arcos

Portugal

Orlistato Ciclum

120 mg

Capsula rigida

Uso orale

Portogallo

| Pharmaceutical Works Polpharma S.A. |
| --- |
| 19, Pelplinska street |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A.

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistato Ratiopharm

60 mg

Capsula rigida

Uso orale

Portogallo

| Pharmaceutical Works Polpharma S.A. |
| --- |
| 19, Pelplinska street |
| 83-200 Starogard Gdanski |
| Poland |

Pharmaceutical Works Polpharma S.A.

19, Pelplinska street

83-200 Starogard Gdanski

Poland

Orlistato Ratiopharm

120 mg

Capsula rigida

Uso orale

Romania

| Pharmaceutical Works Polpharma SA, |
| --- |
| Address: 19, Pelplińska Street, |
| 83-200 Starogard Gdański, |
| Poland |

Pharmaceutical Works Polpharma SA,

Address: 19, Pelplińska Street,

83-200 Starogard Gdański,

Poland

Sulixa

60 mg

Capsula rigida

Uso orale

Romania

| Pharmaceutical Works Polpharma SA, |
| --- |
| Address: 19, Pelplińska Street, |
| 83-200 Starogard Gdański, |
| Poland |

Pharmaceutical Works Polpharma SA,

Address: 19, Pelplińska Street,

83-200 Starogard Gdański,

Poland

Orlistat Polpharma

120 mg

Capsula rigida

Uso orale

Slovacchia

| TEVA Pharmaceuticals Slovakia s.r.o. |
| --- |
| Teslova 26 |
| Bratislava 821 02 |
| Slovak Republic |

TEVA Pharmaceuticals Slovakia s.r.o.

Teslova 26

Bratislava 821 02

Slovak Republic

Orlistat Teva 60 mg

60 mg

Capsula rigida

Uso orale

Slovacchia

| TEVA Pharmaceuticals Slovakia s.r.o. |
| --- |
| Teslova 26 |
| Bratislava 821 02 |
| Slovak Republic |

TEVA Pharmaceuticals Slovakia s.r.o.

Teslova 26

Bratislava 821 02

Slovak Republic

Orlistat Teva 120 mg

120 mg

Capsula rigida

Uso orale

Slovacchia

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19, Pelpliňska Str. |
| 83-200 Starogard Gdaňski |
| Poland |

Pharmaceutical Works POLPHARMA SA

19, Pelpliňska Str.

83-200 Starogard Gdaňski

Poland

Orlistat Polpharma 60 mg

60 mg

Capsula rigida

Uso orale

Slovacchia

| Pharmaceutical Works POLPHARMA SA |
| --- |
| 19, Pelpliňska Str. |
| 83-200 Starogard Gdaňski |
| Poland |

Pharmaceutical Works POLPHARMA SA

19, Pelpliňska Str.

83-200 Starogard Gdaňski

Poland

Orlistat Polpharma 120 mg

120 mg

Capsula rigida

Uso orale

Svezia

| Sandoz A/S,, Edvard Thomsens Vej 14 |
| --- |
| DK-2300 Köpenhamn S, |
| Denmark |

Sandoz A/S,, Edvard Thomsens Vej 14

DK-2300 Köpenhamn S,

Denmark

Orlistat Sandoz

60 mg

Capsula rigida

Uso orale

Paesi Bassi

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH ALMERE |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Orlistat Sandoz 60 mg

60 mg

Capsula rigida

Uso orale

Paesi Bassi

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH ALMERE |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH ALMERE

The Netherlands

Orlistat Sandoz 120 mg

120 mg

Capsula rigida

Uso orale

Regno Unito

| Teva UK Limited, |
| --- |
| Brampton Road, |
| Hampden Park, |
| Eastbourne, |
| East Sussex |
| BN22 9AG |
| United Kingdom |

Teva UK Limited,

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex

BN22 9AG

United Kingdom

TEVA UK Orlistat capsules 60 mg

60 mg

Capsula rigida

Uso orale

Regno Unito

| Teva UK Limited, |
| --- |
| Brampton Road, |
| Hampden Park, |
| Eastbourne, |
| East Sussex |
| BN22 9AG |
| United Kingdom |

Teva UK Limited,

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex

BN22 9AG

United Kingdom

TEVA UK Orlistat capsules 120 mg

120 mg

Capsula rigida

Uso orale

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