21 results
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Human medicine European public assessment report (EPAR): Jakavi
ruxolitinib (as phosphate), Myeloproliferative Disorders; Polycythemia Vera; Graft vs Host Disease
Date of authorisation: 23/08/2012, Revision: 28, Authorised, Last updated: 31/07/2023 -
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Human medicine European public assessment report (EPAR): Inrebic
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021,
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, Revision: 4, Authorised, Last updated: 21/03/2023
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National expert: Francesco Onida, Italian Medicines Agency (updated)
- Declaration of interests - 41.98 KB | PDF
- Curriculum Vitae - 66.85 KB | PDF
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National expert: Francesco Rodeghiero, European Medicines Agency (updated)
- Declaration of interests - 44.02 KB | PDF
- Curriculum Vitae - 123.49 KB | PDF
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Referral: Soludox
doxycycline hyclate, Article 13
Status: European Commission final decision, opinion/position date: 12/06/2013, EC decision date: 12/08/2013, Last updated: 24/09/2013Netherlands Soludox 500 mg/g polvere da somministrare nell’acqua … Netherlands Acquadox 500 mg/g polvere da somministrare nell’acqua … -
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Referral: Doxyfar 50%
doxycycline hyclate, associated names: Soludox 500 mg/g, Soludox Vet, Soludox 433 mg/g, Doxy Ort 50%, Article 34
Status: European Commission final decision, opinion/position date: 04/05/2011, EC decision date: 13/07/2011, Last updated: 24/08/2011Netherlands Soludox 500 mg/g polvere per uso in acqua di bevanda … Netherlands Soludox 500 mg/g polvere per uso in acqua di bevanda … -
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Referral: Losec
omeprazole, associated names: Antra, Logastric, Losec Forte, Mopral, Omeprazen, Omeprazole, AstraZeneca, Zoltum, Article 30 referrals
Status: European Commission final decision, opinion/position date: 20/01/2010, EC decision date: 10/06/2010, Last updated: 19/09/2011 -
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Referral: Strenzen 500/125-mg/g powder
amoxicillin, clavulanic acid, Article 33
Status: European Commission final decision, opinion/position date: 10/04/2013, EC decision date: 12/08/2013, Last updated: 19/09/2013STRENZEN 500/125 mg/g polvere per somministrazione in … -
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Referral: Bleomycin
bleomycin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2008, EC decision date: 12/03/2009, Last updated: 31/03/2009 -
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Referral: Girolan and its associated name Apralan
apramycin sulfate, associated names: Apralan, Article 34
Status: European Commission final decision, Last updated: 15/06/2018Italy Apralan Solubile polvere per soluzione orale per … -
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Referral: Veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and, or poultry
lincomycin, spectinomycin, associated names: Please see Annex I, Article 35
Status: European Commission final decision, opinion/position date: 19/05/2016, EC decision date: 22/08/2016, Last updated: 16/09/2016 -
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Referral: Linco-Spectin 100 and associated names
lincomycin, spectinomycin, Article 34
Status: European Commission final decision, opinion/position date: 10/04/2014, EC decision date: 11/07/2014, Last updated: 04/09/2014Roma Italy LINCOSPECTIN Polvere orale per uso in acqua da … -
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Referral: Colistin oral
colistin, Article 35
Status: European Commission final decision, opinion/position date: 11/12/2014, EC decision date: 16/03/2015, Last updated: 13/04/2015 -
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Orphan designation: Tobramycin for: Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis
Date of designation: 17/03/2003, Expired, Last updated: 31/07/2023 -
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National expert: Marek Jutel, European Medicines Agency (updated)
- Declaration of interests - 44.08 KB | PDF
- Curriculum Vitae - 297.63 KB | PDF
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Orphan designation: Beta-artemether, lumefantrine for: Treatment of malaria
Date of designation: 28/01/2010, Positive, Last updated: 25/02/2010 -
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Innovative Medicines Initiative WEB-RADR workshop
European Medicines Agency, London, UK, 10/12/2014, Last updated: 01/10/2015and digital media Fabio Polverino, European Data Protection … and digital media Fabio Polverino (EDPS office) 15:40 … -
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Outcomes of imposed non-interventional post-authorisation safety studies
Last updated: 27/06/2022 -
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Public data from Article 57 database
Last updated: 30/06/2023 -
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Guidance documents
Last updated: 19/07/2022 -
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Workshop on identifying opportunities for 'big data' in medicines development and regulatory science
CCT Venue Plus, London, UK, from 14/11/2016 to 15/11/2016, Last updated: 04/01/2017