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News: Are you an SME interested in funding of Adverse Drug Reaction research through the European Commission's 7th Framework Programme?
Last updated: 27/07/2010pancreatitis/pancreatic cancer. • Epoetins: Risk of tumour growth progression … for drug safety research: Epoetins and tumour progression, shortened … -
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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,
, 
, Revision: 19, Authorised, Last updated: 27/11/2019
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Human medicine European public assessment report (EPAR): Jakavi
ruxolitinib (as phosphate), Myeloproliferative Disorders
Date of authorisation: 23/08/2012, Revision: 18, Authorised, Last updated: 05/02/2020 -
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Human medicine European public assessment report (EPAR): Xeloda
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 02/02/2001, Revision: 24, Authorised, Last updated: 28/08/2019methoxy polyethylene glycol-epoetin beta), Pegasys (peginterferon … methoxy polyethylene glycol-epoetin beta, used for the treatment … -
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Human medicine European public assessment report (EPAR): Xenical
orlistat, Obesity
Date of authorisation: 29/07/1998, Revision: 23, Authorised, Last updated: 22/01/2019methoxy polyethylene glycol-epoetin beta), Pegasys (peginterferon … methoxy polyethylene glycol-epoetin beta, used for the treatment … -
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Human medicine European public assessment report (EPAR): Rubraca
rucaparib camsylate, Ovarian Neoplasms
Date of authorisation: 23/05/2018,, 
, Revision: 3, Authorised, Last updated: 18/12/2019
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Human medicine European public assessment report (EPAR): Tamiflu
oseltamivir, Influenza, Human
Date of authorisation: 20/06/2002, Revision: 37, Authorised, Last updated: 20/11/2019methoxy polyethylene glycol-epoetin beta), Pegasys (peginterferon … methoxy polyethylene glycol-epoetin beta, used for the treatment … -
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Human medicine European public assessment report (EPAR): Nespo
darbepoetin alfa, Kidney Failure, Chronic, Anemia, Cancer
Date of authorisation: 08/06/2001, Revision: 19, Withdrawn, Last updated: 28/01/2009 -
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Human medicine European public assessment report (EPAR): Pegasys
peginterferon alfa-2a, Hepatitis C, Chronic, Hepatitis B, Chronic
Date of authorisation: 20/06/2002, Revision: 37, Authorised, Last updated: 07/10/2019methoxy polyethylene glycol-epoetin beta), Pegasys (peginterferon … methoxy polyethylene glycol-epoetin beta, used for the treatment … -
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Human medicine European public assessment report (EPAR): Alli (previously Orlistat GSK)
orlistat, Obesity
Date of authorisation: 22/07/2007, Revision: 16, Authorised, Last updated: 04/12/2018methoxy polyethylene glycol-epoetin beta), Pegasys (peginterferon … methoxy polyethylene glycol-epoetin beta, used for the treatment … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012
CHMP, Last updated: 20/07/2012methoxy polyethylene glycol-epoetin beta, peginterferon alfa-2a … -
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Withdrawn application: Aranesp
darbepoetin alfa, date of withdrawal: 21/02/2018, Post-authorisation, Last updated: 24/04/2018 -
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Withdrawn application: Omontys
peginesatide, date of withdrawal: 28/06/2013, Initial authorisation, Last updated: 28/06/2013with another medicine called epoetin. The main measure of effectiveness … -
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Withdrawn application: Orathecin
Rubitecan, date of withdrawal: 19/01/2006, Initial authorisation, Last updated: 23/01/2006 -
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National expert: Gianluca Trifiro, European Medicines Agency (updated)
- Declaration of interests - 80.97 KB | PDF
- Curriculum Vitae - 150.29 KB | PDF
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)20-23 June 2011
CHMP, Last updated: 24/06/2011neuropathy. Retacrit (epoetin zeta), from Hospira UK Ltd … epoetin zeta), from Hospira UK Ltd … -
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Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir, associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, Last updated: 09/03/2017 -
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Opinion/decision on a Paediatric investigation plan (PIP): Roxadustat
Decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology, PIP number: EMEA-001557-PIP01-13-M03, decision date: 17/04/2019, Last updated: 31/01/2019, compliance check: Xthe European Union, such as Epoetin alfa, that are known to work … -
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PRAC recommendations on safety signals (updated)
Last updated: 06/04/2020 -
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PDCO: Agendas, minutes and meeting reports
Last updated: 27/01/2020 -
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PRAC: Agendas, minutes and highlights
Last updated: 14/06/2019 -
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PRAC: meeting archive 2012-2013
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Committee for Medicinal Products for Human Use (CHMP): 17-20 September 2018
European Medicines Agency, London, UK, from 17/09/2018 to 20/09/2018, Last updated: 31/10/2018 -
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PRAC: Committee agendas, minutes and meeting highlights report archive 2012-2013
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 July 2017
European Medicines Agency, London, UK, from 03/07/2017 to 06/07/2017, Last updated: 13/03/2014