26 results
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Human medicine European public assessment report (EPAR): Zalasta
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 27/09/2007,
, Revision: 19, Authorised, Last updated: 09/12/2021
Zalasta Schizophrenia Spectrum and … Zalasta … Zalasta, INN-olanzapine European … -
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Press release: European Medicines Agency recommends authorisation of first generic medicine for human use
Last updated: 19/07/2007first positive opinion is for Zalasta (olanzapine), from Krka … The reference product for Zalasta is ZYPREXA from Eli Lilly … Generic Related information Zalasta: EPAR Questions and answers … -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of designation: 22/05/2006, Expired, Last updated: 25/11/2021 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of designation: 27/07/2005, Positive, Last updated: 14/06/2021 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of designation: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 November - 1 December 2022
European Medicines Agency, Amsterdam, the Netherlands, from 28/11/2022 to 01/12/2022, Last updated: 29/11/2022 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 06/02/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/02/2021 to 11/02/2021, Last updated: 08/02/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2021 to 10/06/2021, Last updated: 07/06/2021 -
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Download medicine data
Last updated: 02/12/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 April 2018
European Medicines Agency, London, UK, from 09/04/2018 to 12/04/2018, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 October 2013
European Medicines Agency, London, UK, from 07/10/2013 to 10/10/2013, Last updated: 02/07/2012 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 September 2018
European Medicines Agency, London, UK, from 03/09/2018 to 06/09/2018, Last updated: 13/03/2014 -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,16-19 July 2007
CHMP, Last updated: 19/07/2007use. The product concerned, Zalasta (olanzapine), from Krka d.d … The reference product for Zalasta is Zyprexa, from Eli Lilly … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 November - 1 December 2016
European Medicines Agency, London, UK, from 28/11/2016 to 01/12/2016, Last updated: 13/03/2014 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2021
PRAC, Last updated: 12/02/2021CAP); OLAZAX DISPERZI (CAP); ZALASTA (CAP); ZYPADHERA (CAP); ZYPREXA … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 June 2021
PRAC, Last updated: 11/06/2021 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2022
PRAC, Last updated: 02/12/2022 -
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Leaflets
Last updated: 23/09/2016 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Guidance documents
Last updated: 19/07/2022 -
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Annual reports and work programmes
Last updated: 10/06/2022 -
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Press release: EMEA reports strong performance in regulatory and public-health activities in 2007; the outlook for 2008 is even higher application numbers and a focus on advanced-therapy medicines
Last updated: 10/03/2008 -
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PRAC: meeting archive 2012-2014
Last updated: 13/05/2016 -
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CHMP: meeting archive 2001-2009
Last updated: 18/11/2013