| Gazzetta n. 60 del 13 marzo 2007 (vai al sommario) |
| AGENZIA ITALIANA DEL FARMACO |
| COMUNICATO |
| Modificazione dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, di alcune specialita' medicinali. |
| 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 gia' 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 ===================================================================== Ditta | Medicinale | Procedura europea ===================================================================== | |IE/H/0117/003 Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/017 --------------------------------------------------------------------- | |IE/H/0117/003 Novartis Farma S.p.A |CALCITONINA SANDOZ |-004/IB/018 --------------------------------------------------------------------- | |IE/H/0117/003 Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/033 --------------------------------------------------------------------- | |IE/H/0117/003 Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/034 --------------------------------------------------------------------- | |IE/H/0117/003 Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/035 --------------------------------------------------------------------- | |IE/H/0117/003 Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/036 --------------------------------------------------------------------- | |IE/H/0117/003 Novartis Farma S.p.A. |CALCITONINA SANDOZ |-004/IB/037 --------------------------------------------------------------------- Abbott S.p.A. |SIMDAX |SE/H/0233/ 001/IA/002 --------------------------------------------------------------------- Abbott S.p.A. |SIMDAX |SE/H/0233/ 001/IA/003 --------------------------------------------------------------------- Bayer AG |PROFLOX |DE/H/0157/ 001/IB/019 --------------------------------------------------------------------- Worwag Pharma GMBH & | | Co. KG |CARVEDILOLO WORWAG |SE/H/0351/ 004/IA/009 --------------------------------------------------------------------- Worwag Pharma GMBH & | | Co. KG |CARVEDILOLO WORWAG |SE/H/0351/ 001/IA/006 --------------------------------------------------------------------- Worwag Pharma GMBH & | | Co. KG |CARVEDILOLO WORWAG |SE/H/0351/ 002/IA/007 --------------------------------------------------------------------- Abbott S.p.A. |ZEMPLAR |ES/H/0113/ 001/IB/015 --------------------------------------------------------------------- Therabel Gienne Pharma| |NL/H/0113/001 S.p.A. |PRONTALGIN |-003/IA/027 --------------------------------------------------------------------- Abbott S.p.A. |SIMDAX |SE/H/0233/ 001/IB/004 --------------------------------------------------------------------- | |DE/H/0109/001 Pfizer Italia S.r.l. |XARATOR |-004/IA/071 --------------------------------------------------------------------- Novo Nordisk | |DK/H/0117/001 Farmaceutici S.p.A. |ESTROFEM |-002/IA/016 --------------------------------------------------------------------- Winthrop | | Pharmaceuticals Italia| |DK/H/0508/001 S.r.l. |GABAPENTINA WINTHROP |-003/IB/006 --------------------------------------------------------------------- Schering S.p.A. |ARIANNA |FR/H/0159/ 001/IB/025 --------------------------------------------------------------------- Abbott S.p.A. |PANTECTA |DE/H/0270/ 002/IA/114 --------------------------------------------------------------------- | |UK/H/0647/ Schering S.p.A. |MAVERAL |001-002/IA/006 --------------------------------------------------------------------- Wyeth Consumer |ADVIL ISTANT LIQUI | Healthcare S.p.A. |GELS |UK/H/0368/ 001/IB/027 --------------------------------------------------------------------- | |UK/H/0647/001 Solvay Pharma S.p.A. |DUMIROX |-002/IA/006 --------------------------------------------------------------------- Solvay Pharmaceuticals| |UK/H/0647/001 B.V. |FEVARIN |-002/IA/006 --------------------------------------------------------------------- Eli Lilly Italia | | S.p.A. |PROZAC |FR/H/0242/ 001/IA/008 --------------------------------------------------------------------- Merck Generics Italia |CARVEDILOLO MERCK |SE/H/0349/001 S.p.A. |GENERICS |-004/IA/011 --------------------------------------------------------------------- LPB Istituto | | Farmaceutico S.r.l. |CORIXIL |SE/H/0565/ 003/IB/004 --------------------------------------------------------------------- | |IE/H/0118/001 Norton Waterford LTD |BECLOMETASONE NORTON |-003/IB/015 --------------------------------------------------------------------- Menarini International| | Operations Luxembourg | |DE/H/0385/001 S.A. |PLAUNAC |-003/IA/016 --------------------------------------------------------------------- |AMOXICILLINA E ACIDO | Ratiopharm GMBH |CLAVULANICO RATIOPHARM|FI/H/0347/ 001/IB/007 --------------------------------------------------------------------- Recordati Industria | | Chimica Farmaceutica | | S.p.A. |PEPTAZOL |DE/H/0271/ 001/IB/113 --------------------------------------------------------------------- Recordati Industria | | Chimica Farmaceutica | | S.p.A. |PEPTAZOL |DE/H/0268/ 002/IB/113 --------------------------------------------------------------------- | |DE/H/0270/001 Abbott S.p.A. |PANTECTA |-002/IB/113 --------------------------------------------------------------------- Knoll - Ravizza | | Farmaceutici S.p.A. |ZIAXEL |NL/H/0108/ 003/IA/011 --------------------------------------------------------------------- | |DE/H/0169/001 Bracco S.p.A. |ECTIVA |-002/IB/028 --------------------------------------------------------------------- | |DE/H/0168/001 Abbott S.p.A. |REDUCTIL |-002/IB/031 --------------------------------------------------------------------- | |DE/H/0170/001 Abbott S.p.A. |REDUXADE |-002/IB/027 --------------------------------------------------------------------- Eli Lilly Italia | |UK/H/0636/ S.p.A. |PROZAC |001,003/IA/011 --------------------------------------------------------------------- Pfizer Italia S.r.l. |XALACOM |SE/H/0249/ 001/IB/024 --------------------------------------------------------------------- | |DE/H/0270/001 Abbott S.p.A. |PANTECTA |-002/IA/116 --------------------------------------------------------------------- Recordati Industria | | Chimica Farmaceutica | | S.p.A. |PEPTAZOL |DE/H/0271/ 001/IA/116 --------------------------------------------------------------------- | |DE/H/0269/001 Almirall S.p.A. |PANTOPAN |-002/IA/116 --------------------------------------------------------------------- Knoll - Ravizza | | Farmaceutici S.p.A. |ZIAXEL |NL/H/0108/ 003/IB/014 --------------------------------------------------------------------- Teva Pharma Italia | |NL/H/0203/001 S.r.L. |ALPRAZOLAM TEVA |-003/IA/002 --------------------------------------------------------------------- Merck Generics Italia |SERTRALINA MERCK |ES/H/0126/001 S.p.A. |GENRICS |-002/IA/001 --------------------------------------------------------------------- GlaxoSmithKline S.p.A.|MALARONE |UK/H/0170/ 001/IB/024 --------------------------------------------------------------------- | |FI/H/0182/001 Hexal S.p.A. |CARVEDILOLO HEXAL |-005/IB/009 --------------------------------------------------------------------- | |FI/H/0182/001 Hexal S.p.A. |CARVEDILOLO HEXAL |-005/IB/010 --------------------------------------------------------------------- Hexal S.p.A. |CARVEDILOLO HEXAL |FI/H/0182/ 005/IB/011 --------------------------------------------------------------------- Norgine Italia S.r.l. |MOVICOL |UK/H/0131/ 001/IB/027 --------------------------------------------------------------------- Mcneil S.r.l. |PEPCIDDUAL |FR/H/0169/ 001/IA/029 --------------------------------------------------------------------- Sanofi-Aventis S.p.A. |ELOXATIN |FR/H/0144/ 001/IA/025 --------------------------------------------------------------------- Sanofi-Aventis S.p.A. |ELOXATIN |FR/H/0144/ 001/IA/026 --------------------------------------------------------------------- | |SE/H/0565/001 Novartis Farma S.p.A. |COTAREG |-003/IB/030 --------------------------------------------------------------------- LPB Istituto | |SE/H/0565/001 Farmaceutico S.r.l. |CORIXIL |-003/IB/030 --------------------------------------------------------------------- LPB Istituto | |SE/H/0565/001 Farmaceutico S.r.l. |CORIXIL |-003/IB/031 --------------------------------------------------------------------- | |SE/H/0565/001 Novartis Farma S.p.A. |COTAREG |-003/IB/031 --------------------------------------------------------------------- | |FR/H/0107/001 Cephalon France |GABITRIL |-004/IA/045 --------------------------------------------------------------------- Vifor France S.p.A. |VENOFER |UK/H/0313/ 001/IB/019 --------------------------------------------------------------------- Boehringer Ingelheim | | Italia S.p.A. |ACTILYSE |DE/H/0015/ 004/IA/046 --------------------------------------------------------------------- Boehringer Ingelheim | | Italia S.p.A. |ACTILYSE |DE/H/0015/ 004/IA/045 --------------------------------------------------------------------- |IPRATROPIO BROMURO | Arrow Generics LTD |ARROW |UK/H/0771/ 001/IA/001 --------------------------------------------------------------------- Fresenius Kabi | | Deutschland GMBH |DIPEPTIVEN |DE/H/0101/ 001/IB/013 --------------------------------------------------------------------- | |UK/H/0182/003 Bracco S.p.A. |MEMAC |-004/IA/052 --------------------------------------------------------------------- | |UK/H/0182/ Pfizer Italia S.r.l. |ARICEPT |003-004/IA/053 --------------------------------------------------------------------- | |UK/H/0182/003 Bracco S.p.A. |MEMAC |-004/IA/053 --------------------------------------------------------------------- | |UK/H/0182/003 Pfizer Italia S.r.l. |ARICEPT |-004/IA/052 --------------------------------------------------------------------- Bracco S.p.A. |ESOPRAL |SE/H/0262/ 003/IB/042 --------------------------------------------------------------------- Istituto | | Farmacobiologico | | Malesci S.p.A. |LUCEN |SE/H/0251/ 003/IB/041 --------------------------------------------------------------------- Simesa S.p.A. |AXAGON |SE/H/0234/ 003/IB/040 --------------------------------------------------------------------- Bracco S.p.A. |ESOPRAL |SE/H/0262/ 003/IB/041 --------------------------------------------------------------------- Simesa S.p.A. |AXAGON |SE/H/0234/ 003/IB/039 --------------------------------------------------------------------- Istituto | | farmacobiologico | | Malesci S.p.a. |LUCEN |SE/H/0251/ 003/IB/040 --------------------------------------------------------------------- Glaxosmithkline S.p.a.|AVODART |SE/H/0304/ 001/IA/026 --------------------------------------------------------------------- Glaxo Allen S.p.a. |DUAGEN |SE/H/0305/ 001/IA/024 --------------------------------------------------------------------- Recordati industria | | chimica farmaceutica | |UK/H/0311/001 S.p.a. |NITROCOR |-003/IA/013 --------------------------------------------------------------------- Winthrop | | Pharmaceuticals Italia| |DK/H/0508/001 S.r.l. |GABAPENTINA WINTHROP |-003/IA/011 --------------------------------------------------------------------- Winthrop | | Pharmaceuticals Italia| |DK/H/0508/001 S.r.l. |GABAPENTINA WINTHROP |-003/IA/010 --------------------------------------------------------------------- Orion Corporation |SALBIDREX |DK/H/0125/ 001/IA/028 --------------------------------------------------------------------- Orion Corporation |SALBIDREX |DK/H/0125/ 001/IA/026 --------------------------------------------------------------------- Orion Corporation |SALBIDREX |DK/H/0125/ 001/IA/027 --------------------------------------------------------------------- | |SE/H/0121/001 Astrazeneca S.p.a. |OXIS |-002/IB/035 --------------------------------------------------------------------- | |NL/H/0197/001 Fournier Pharma S.p.a.|OSIPINE |-002/IA/010 --------------------------------------------------------------------- | |NL/H/0198/001 Italfarmaco S.p.a. |VASEXTEN |-002/IA/008 --------------------------------------------------------------------- Sigma-Tau Industrie | | farmaceutiche riunite | |NL/H/0199/001 S.p.a. |LIBRADIN |-002/IA/008 --------------------------------------------------------------------- | |SE/H/0259/001 Simesa S.p.a. |ASSIEME MITE |-002/IA/029 --------------------------------------------------------------------- | |SE/H/0258/001 Simesa S.p.a. |ASSIEME |-002/IA/029 --------------------------------------------------------------------- Astrazeneca S.p.a. |SYMBICORTMITE |SE/H/0230/ 001/IA/023 --------------------------------------------------------------------- Abbott S.p.a. |SIMDAX |SE/H/0233/ 001/IA/008 --------------------------------------------------------------------- | |SE/H/0229/ Astrazeneca S.p.a. |SYMBICORT |001-002/IA/031 --------------------------------------------------------------------- Glaxo Allen S.p.a. |DUAGEN |SE/H/0305/ 001/IB/025 --------------------------------------------------------------------- GlaxoSmithKline S.p.a.|AVODART |SE/H/0304/ 001/IB/025 --------------------------------------------------------------------- GlaxoSmhtkKine S.p.a. |AVODART |SE/H/0304/ 001/IB/027 --------------------------------------------------------------------- Glaxo Allen S.p.a. |DUAGEN |SE/H/0305/ 001/IB/023 --------------------------------------------------------------------- | |UK/H/0413/ Pfizer Italia S.r.l. |CAVERJECT |001-002/IA/017 --------------------------------------------------------------------- Winthrop | | Pharmaceuticals Italia| |DK/H/0508/001 S.r.l. |GABAPENTINA WINTHROP |-003/IB/012 --------------------------------------------------------------------- Bayer S.p.a. |TRANSIPEG |FR/H/0117/ 001/IA/031 --------------------------------------------------------------------- Prodotti Formenti | | S.r.l. |LYBELLA |DE/H/0516/ 001/IB/011 |
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