27 results
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Human medicine European public assessment report (EPAR): Jorveza
budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,,
, Revision: 2, Authorised, Last updated: 04/06/2020
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Herbal medicinal product: Mate folium
Ilex paraguariensis St. Hilaire, Maté Leaf, F: Assessment finalised, Last updated: 01/03/2018 -
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Referral: Calcium Sandoz
Calcium lactate gluconate, Calcium carbonate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005CALCIUM-SANDOZ 1000mg compresse effervescenti Ca 1000mg Effervescent … CALCIUM-SANDOZ 500mg compresse effervescenti Ca 500mg Effervescent tablets … -
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Referral: Piroxicam
piroxicam, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/06/2007, EC decision date: 07/09/2007, Last updated: 31/01/2008 -
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Referral: Domperidone-containing medicines
domperidone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 01/09/2014, Last updated: 11/09/2014 -
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Referral: Diclofenac-containing medicines
diclofenac, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 25/09/2013, Last updated: 27/11/2013 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of first decision: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of first decision: 22/05/2006, Positive, Last updated: 01/07/2016 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of first decision: 27/07/2005, Positive, Last updated: 23/03/2015 -
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PRAC recommendations on safety signals
Last updated: 06/01/2020 -
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Sodium
Last updated: 10/10/2017 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2015
European Medicines Agency, London, UK, from 07/04/2015 to 10/04/2015, Last updated: 20/05/2015 -
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Pharmaceutical development of medicines for paediatric use
Last updated: 31/07/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 April 2014
European Medicines Agency, London, UK, from 07/04/2014 to 10/04/2014, Last updated: 13/08/2013 -
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Workshop on the 'Guideline on pharmaceutical development of medicines for paediatric use'
European Medicines Agency, London, UK, 01/12/2014, Last updated: 02/12/2015 -
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Paediatric Committee (PDCO): 12-14 November 2014
European Medicines Agency, London, UK, from 12/11/2014 to 14/11/2014, Last updated: 10/12/2010 -
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PRAC recommendations on safety signals: monthly overviews: Archive
Last updated: 30/05/2017 -
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Public data from Article 57 database (updated)
Last updated: 16/02/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 February 2015
European Medicines Agency, London, UK, from 09/02/2015 to 12/02/2015, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 March 2015
European Medicines Agency, London, UK, from 09/03/2015 to 12/03/2015, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 September 2014
European Medicines Agency, London, UK, from 08/09/2014 to 11/09/2014, Last updated: 13/08/2013 -
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Paediatric formulations
Last updated: 10/08/2015 -
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PRAC: meeting archive 2014-2015
Last updated: 13/05/2016 -
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Management Board meeting: 17 March 2016
European Medicines Agency, London, UK, 17/03/2016, Last updated: 19/06/2014 -
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News: Safer use of medicines by preventing medication errors
Last updated: 27/11/2015