114 results
Keyword Advate - Polvere Remove keyword
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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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Opinion/decision on a Paediatric investigation plan (PIP): Veyvondi, vonicog alfa (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001164-PIP01-11-M06, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 07/09/2022, Last updated: 19/09/2023, Compliance check: XrVWF), with or without ADVATE, in the treatment of bleeding … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 11/04/2023 to 14/04/2023, Last updated: 07/07/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 24-26 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 24/04/2023 to 26/04/2023, Last updated: 07/07/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 25/09/2023 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 11/09/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 24-27 January 2022
European Medicines Agency, Amsterdam, the Netherlands, from 24/01/2022 to 27/01/2022, Last updated: 16/03/2022 -
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Committee for Medicinal Products for Human Use (CHMP): 27-30 March 2023
European Medicines Agency, Amsterdam, the Netherlands, from 27/03/2023 to 30/03/2023, Last updated: 22/05/2023 -
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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 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 March 2022
European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2022 to 24/03/2022, Last updated: 12/08/2022 -
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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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Joint EMA / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting-factor concentrates with respect to potency assays used for labelling and testing of post-infusion samples
European Medicines Agency, London, UK, from 28/11/2013 to 29/11/2013, Last updated: 10/09/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 July 2013
European Medicines Agency, London, UK, from 08/07/2013 to 11/07/2013, Last updated: 02/07/2012