107 results
Keyword Alimta - Polvere Remove keyword
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Human medicine European public assessment report (EPAR): Abraxane
paclitaxel, Breast Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 11/01/2008, Revision: 29, Authorised, Last updated: 13/05/2022 -
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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: 27, Authorised, Last updated: 17/01/2023 -
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National expert: Francesco Onida, Italian Medicines Agency (updated)
- Declaration of interests - 42.89 KB | PDF
- Curriculum Vitae - 66.85 KB | PDF
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Human medicine European public assessment report (EPAR): Tecentriq
atezolizumab, Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017, Revision: 21, Authorised, Last updated: 07/03/2023 -
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Human medicine European public assessment report (EPAR): Gavreto
pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021,
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, Revision: 3, Authorised, Last updated: 10/06/2022
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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,
, Revision: 17, Authorised, Last updated: 29/11/2022
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Withdrawn application: Pemetrexed ditromethamine Hospira
pemetrexed, date of withdrawal: 22/09/2016, Initial authorisation, Last updated: 21/12/2016the European Union called Alimta. For more information on generic … -
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Withdrawn application: Erbitux
cetuximab, date of withdrawal: 17/09/2012, Post-authorisation, Last updated: 22/11/2012 -
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National expert: Francesco Rodeghiero, European Medicines Agency (updated)
- Declaration of interests - 43.15 KB | PDF
- Curriculum Vitae - 121.63 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, Positive, Last updated: 03/04/2023 -
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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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CHMP: Agendas, minutes and highlights (updated)
Last updated: 06/06/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/10/2022 to 13/10/2022, Last updated: 23/11/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 7-10 November 2022
European Medicines Agency, Amsterdam, the Netherlands, from 07/11/2022 to 10/11/2022, Last updated: 10/01/2023 -
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EudraVigilance training and support (updated)
Last updated: 01/06/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 16-19 May 2022
European Medicines Agency, Amsterdam, the Netherlands, from 16/05/2022 to 19/05/2022, Last updated: 12/08/2022