14 results
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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: Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products
albendazole, Article 35
Status: European Commission final decision, opinion/position date: 05/11/2020, EC decision date: 18/01/2021, Last updated: 22/02/2021Italy Valbazen 100 mg/ml sospensione per uso orale per bovini … Sverminator 10, 100 mg/ml, sospensione orale per bovini ed ovini … Albex Gold 200 mg/ml sospensione orale per bovini Albendazole … -
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Referral: Florgane
florfenicol, Article 33
Status: European Commission final decision, opinion/position date: 06/03/2013, EC decision date: 23/05/2013, Last updated: 10/07/2013Belgium Florgane 300 mg/ml sospensione iniettabile per bovini e … -
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Referral: Cevazuril
toltrazuril, Article 33
Status: European Commission final decision, opinion/position date: 09/12/2009, EC decision date: 26/03/2010, Last updated: 05/05/2010FRANCE CEVAZURIL 50 mg/ml, sospensione orale per suinetti Oral … -
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Referral: Terfenadine
terfenadine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/11/1997, EC decision date: 22/09/1998, Last updated: 22/01/1998 -
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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Date of first decision: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -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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Orphan designation: Mercaptopurine for: Treatment of acute lymphoblastic leukaemia
Date of first decision: 30/04/2009, Positive, Last updated: 18/12/2018 -
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Orphan designation: Beta-artemether, lumefantrine for: Treatment of malaria
Date of first decision: 28/01/2010, Positive, Last updated: 25/02/2010 -
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Opinion/decision on a Paediatric investigation plan (PIP): Valaciclovir (hydrochloride)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001548-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral suspension
Decision date: 08/08/2014, Last updated: 17/02/2015, Compliance check: X -
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Public data from Article 57 database
Last updated: 16/02/2021 -
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Stakeholder meeting on product shortages due to manufacturing and quality problems: developing a proactive approach to prevention
European Medicines Agency, London, UK, 09/10/2015, Last updated: 27/01/2016 -
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Guidance documents
Last updated: 31/01/2014