Serie Generale n. 60 del 13-3-2007
ESTRATTI, SUNTI E COMUNICATI
AGENZIA ITALIANA DEL FARMACO
AGENZIA ITALIANA DEL FARMACO
COMUNICATO
Modificazione dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, di alcune specialita' medicinali. (GU Serie Generale n.60 del 13-03-2007)

Estratto provvedimento UPC/I/5825 del 23 febbraio 2007
Tipo di modifica: variazioni di tipo I che non comportano
modifica stampati.
Le variazioni relative alle procedure citate in allegato devono
considerarsi favorevolmente concluse.
I lotti già prodotti, possono essere mantenuti in commercio fino
alla data di scadenza indicata in etichetta.
Il presente provvedimento entra in vigore il giorno successivo
alla sua pubblicazione nella Gazzetta Ufficiale della Repubblica
italiana.

Allegato

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Ditta | Medicinale | Procedura europea
=====================================================================
| |IE/H/0117/003
Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/017
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| |IE/H/0117/003
Novartis Farma S.p.A |CALCITONINA SANDOZ |-004/IB/018
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| |IE/H/0117/003
Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/033
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| |IE/H/0117/003
Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/034
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| |IE/H/0117/003
Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/035
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| |IE/H/0117/003
Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/036
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| |IE/H/0117/003
Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/037
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Abbott S.p.A. |SIMDAX |SE/H/0233/ 001/IA/002
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Abbott S.p.A. |SIMDAX |SE/H/0233/ 001/IA/003
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Bayer AG |PROFLOX |DE/H/0157/ 001/IB/019
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Worwag Pharma GMBH &amp; | |
Co. KG |CARVEDILOLO WORWAG |SE/H/0351/ 004/IA/009
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Worwag Pharma GMBH &amp; | |
Co. KG |CARVEDILOLO WORWAG |SE/H/0351/ 001/IA/006
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Worwag Pharma GMBH &amp; | |
Co. KG |CARVEDILOLO WORWAG |SE/H/0351/ 002/IA/007
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Abbott S.p.A. |ZEMPLAR |ES/H/0113/ 001/IB/015
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Therabel Gienne Pharma| |NL/H/0113/001
S.p.A. |PRONTALGIN |-003/IA/027
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Abbott S.p.A. |SIMDAX |SE/H/0233/ 001/IB/004
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| |DE/H/0109/001
Pfizer Italia S.r.l. |XARATOR |-004/IA/071
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Novo Nordisk | |DK/H/0117/001
Farmaceutici S.p.A. |ESTROFEM |-002/IA/016
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Winthrop | |
Pharmaceuticals Italia| |DK/H/0508/001
S.r.l. |GABAPENTINA WINTHROP |-003/IB/006
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Schering S.p.A. |ARIANNA |FR/H/0159/ 001/IB/025
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Abbott S.p.A. |PANTECTA |DE/H/0270/ 002/IA/114
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| |UK/H/0647/
Schering S.p.A. |MAVERAL |001-002/IA/006
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Wyeth Consumer |ADVIL ISTANT LIQUI |
Healthcare S.p.A. |GELS |UK/H/0368/ 001/IB/027
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| |UK/H/0647/001
Solvay Pharma S.p.A. |DUMIROX |-002/IA/006
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Solvay Pharmaceuticals| |UK/H/0647/001
B.V. |FEVARIN |-002/IA/006
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Eli Lilly Italia | |
S.p.A. |PROZAC |FR/H/0242/ 001/IA/008
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Merck Generics Italia |CARVEDILOLO MERCK |SE/H/0349/001
S.p.A. |GENERICS |-004/IA/011
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LPB Istituto | |
Farmaceutico S.r.l. |CORIXIL |SE/H/0565/ 003/IB/004
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| |IE/H/0118/001
Norton Waterford LTD |BECLOMETASONE NORTON |-003/IB/015
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Menarini International| |
Operations Luxembourg | |DE/H/0385/001
S.A. |PLAUNAC |-003/IA/016
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|AMOXICILLINA E ACIDO |
Ratiopharm GMBH |CLAVULANICO RATIOPHARM|FI/H/0347/ 001/IB/007
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Recordati Industria | |
Chimica Farmaceutica | |
S.p.A. |PEPTAZOL |DE/H/0271/ 001/IB/113
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Recordati Industria | |
Chimica Farmaceutica | |
S.p.A. |PEPTAZOL |DE/H/0268/ 002/IB/113
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| |DE/H/0270/001
Abbott S.p.A. |PANTECTA |-002/IB/113
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Knoll - Ravizza | |
Farmaceutici S.p.A. |ZIAXEL |NL/H/0108/ 003/IA/011
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| |DE/H/0169/001
Bracco S.p.A. |ECTIVA |-002/IB/028
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| |DE/H/0168/001
Abbott S.p.A. |REDUCTIL |-002/IB/031
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| |DE/H/0170/001
Abbott S.p.A. |REDUXADE |-002/IB/027
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Eli Lilly Italia | |UK/H/0636/
S.p.A. |PROZAC |001,003/IA/011
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Pfizer Italia S.r.l. |XALACOM |SE/H/0249/ 001/IB/024
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| |DE/H/0270/001
Abbott S.p.A. |PANTECTA |-002/IA/116
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Recordati Industria | |
Chimica Farmaceutica | |
S.p.A. |PEPTAZOL |DE/H/0271/ 001/IA/116
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| |DE/H/0269/001
Almirall S.p.A. |PANTOPAN |-002/IA/116
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Knoll - Ravizza | |
Farmaceutici S.p.A. |ZIAXEL |NL/H/0108/ 003/IB/014
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Teva Pharma Italia | |NL/H/0203/001
S.r.L. |ALPRAZOLAM TEVA |-003/IA/002
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Merck Generics Italia |SERTRALINA MERCK |ES/H/0126/001
S.p.A. |GENRICS |-002/IA/001
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GlaxoSmithKline S.p.A.|MALARONE |UK/H/0170/ 001/IB/024
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| |FI/H/0182/001
Hexal S.p.A. |CARVEDILOLO HEXAL |-005/IB/009
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| |FI/H/0182/001
Hexal S.p.A. |CARVEDILOLO HEXAL |-005/IB/010
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Hexal S.p.A. |CARVEDILOLO HEXAL |FI/H/0182/ 005/IB/011
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Norgine Italia S.r.l. |MOVICOL |UK/H/0131/ 001/IB/027
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Mcneil S.r.l. |PEPCIDDUAL |FR/H/0169/ 001/IA/029
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Sanofi-Aventis S.p.A. |ELOXATIN |FR/H/0144/ 001/IA/025
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Sanofi-Aventis S.p.A. |ELOXATIN |FR/H/0144/ 001/IA/026
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| |SE/H/0565/001
Novartis Farma S.p.A. |COTAREG |-003/IB/030
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LPB Istituto | |SE/H/0565/001
Farmaceutico S.r.l. |CORIXIL |-003/IB/030
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LPB Istituto | |SE/H/0565/001
Farmaceutico S.r.l. |CORIXIL |-003/IB/031
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| |SE/H/0565/001
Novartis Farma S.p.A. |COTAREG |-003/IB/031
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| |FR/H/0107/001
Cephalon France |GABITRIL |-004/IA/045
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Vifor France S.p.A. |VENOFER |UK/H/0313/ 001/IB/019
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Boehringer Ingelheim | |
Italia S.p.A. |ACTILYSE |DE/H/0015/ 004/IA/046
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Boehringer Ingelheim | |
Italia S.p.A. |ACTILYSE |DE/H/0015/ 004/IA/045
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|IPRATROPIO BROMURO |
Arrow Generics LTD |ARROW |UK/H/0771/ 001/IA/001
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Fresenius Kabi | |
Deutschland GMBH |DIPEPTIVEN |DE/H/0101/ 001/IB/013
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| |UK/H/0182/003
Bracco S.p.A. |MEMAC |-004/IA/052
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| |UK/H/0182/
Pfizer Italia S.r.l. |ARICEPT |003-004/IA/053
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| |UK/H/0182/003
Bracco S.p.A. |MEMAC |-004/IA/053
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| |UK/H/0182/003
Pfizer Italia S.r.l. |ARICEPT |-004/IA/052
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Bracco S.p.A. |ESOPRAL |SE/H/0262/ 003/IB/042
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Istituto | |
Farmacobiologico | |
Malesci S.p.A. |LUCEN |SE/H/0251/ 003/IB/041
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Simesa S.p.A. |AXAGON |SE/H/0234/ 003/IB/040
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Bracco S.p.A. |ESOPRAL |SE/H/0262/ 003/IB/041
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Simesa S.p.A. |AXAGON |SE/H/0234/ 003/IB/039
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Istituto | |
farmacobiologico | |
Malesci S.p.a. |LUCEN |SE/H/0251/ 003/IB/040
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Glaxosmithkline S.p.a.|AVODART |SE/H/0304/ 001/IA/026
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Glaxo Allen S.p.a. |DUAGEN |SE/H/0305/ 001/IA/024
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Recordati industria | |
chimica farmaceutica | |UK/H/0311/001
S.p.a. |NITROCOR |-003/IA/013
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Winthrop | |
Pharmaceuticals Italia| |DK/H/0508/001
S.r.l. |GABAPENTINA WINTHROP |-003/IA/011
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Winthrop | |
Pharmaceuticals Italia| |DK/H/0508/001
S.r.l. |GABAPENTINA WINTHROP |-003/IA/010
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Orion Corporation |SALBIDREX |DK/H/0125/ 001/IA/028
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Orion Corporation |SALBIDREX |DK/H/0125/ 001/IA/026
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Orion Corporation |SALBIDREX |DK/H/0125/ 001/IA/027
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| |SE/H/0121/001
Astrazeneca S.p.a. |OXIS |-002/IB/035
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| |NL/H/0197/001
Fournier Pharma S.p.a.|OSIPINE |-002/IA/010
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| |NL/H/0198/001
Italfarmaco S.p.a. |VASEXTEN |-002/IA/008
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Sigma-Tau Industrie | |
farmaceutiche riunite | |NL/H/0199/001
S.p.a. |LIBRADIN |-002/IA/008
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| |SE/H/0259/001
Simesa S.p.a. |ASSIEME MITE |-002/IA/029
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| |SE/H/0258/001
Simesa S.p.a. |ASSIEME |-002/IA/029
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Astrazeneca S.p.a. |SYMBICORTMITE |SE/H/0230/ 001/IA/023
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Abbott S.p.a. |SIMDAX |SE/H/0233/ 001/IA/008
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| |SE/H/0229/
Astrazeneca S.p.a. |SYMBICORT |001-002/IA/031
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Glaxo Allen S.p.a. |DUAGEN |SE/H/0305/ 001/IB/025
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GlaxoSmithKline S.p.a.|AVODART |SE/H/0304/ 001/IB/025
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GlaxoSmhtkKine S.p.a. |AVODART |SE/H/0304/ 001/IB/027
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Glaxo Allen S.p.a. |DUAGEN |SE/H/0305/ 001/IB/023
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| |UK/H/0413/
Pfizer Italia S.r.l. |CAVERJECT |001-002/IA/017
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Winthrop | |
Pharmaceuticals Italia| |DK/H/0508/001
S.r.l. |GABAPENTINA WINTHROP |-003/IB/012
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Bayer S.p.a. |TRANSIPEG |FR/H/0117/ 001/IA/031
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Prodotti Formenti | |
S.r.l. |LYBELLA |DE/H/0516/ 001/IB/011