40 results
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Orphan designation: N,N'-bis(2-mercaptoethyl)isophthalamide (emeramide) for: Treatment of mercury toxicity
Date of designation: 11/01/2012, Positive, Last updated: 16/08/2017 -
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Orphan designation: Emeramide for: Prevention of mercury toxicity
Date of designation: 20/04/2017, Positive, Last updated: 16/08/2017Emeramide Prevenzione della tossicità da mercurio Latvian Emeramīds … Emeramid Prevenzjoni ta’ tossiċità bil-merkurju Polish Emeramid … -
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Orphan designation: Erdosteine for: Treatment of mercury toxicity
Date of designation: 08/11/2012, Positive, Last updated: 13/12/2012Erdosteina Trattamento di tossicità del mercurio Latvian Erdosteīns … Maltese Erdosteine Kura ta’ tossiċità bil-merkurju Polish Erdosteina … -
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Orphan designation: Erdosteine for: Treatment of lead toxicity
Date of designation: 06/12/2012, Positive, Last updated: 25/01/2013Erdosteina Trattamento della tossicità del piombo Latvian Erdosteīns … Maltese Erdosteine Kura ta’ tossiċità biċ-ċomb Polish Erdosteina … -
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Orphan designation: Octavalent Pseudomonas aeruginosa O-polysaccharide-toxin A conjugate for: Prevention of Pseudomonas aeruginosa infections in patients with cystic fibrosis
Date of designation: 11/12/2001, Withdrawn, Last updated: 15/05/2009 -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense, Poa pratensis, Secale cereale and Artemisia vulgaris
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000851-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: X -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 12/09/2022 -
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Outcomes of imposed non-interventional post-authorisation safety studies
Last updated: 27/06/2022 -
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Workshop for micro-, small- and medium-sized enterprises: statistical perspectives in regulatory clinical development programmes
European Medicines Agency, London, UK, 05/02/2016, Last updated: 14/11/2016 -
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12th pharmacovigilance stakeholder forum
European Medicines Agency, London, UK, 24/09/2018, Last updated: 08/10/2018 -
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European Union (EU) International Organization for Standardization (ISO) identification of medicinal products (IDMP) Task Force meeting
European Medicines Agency, London, UK, 12/06/2015, Last updated: 14/07/2015Verification System. Patrizia Tosseti (Policy Officer at European … -
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Viral safety of plasma-derived medicinal products with respect to hepatitis E virus - Scientific guideline
Last updated: 01/07/2015 -
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Guidance documents
Last updated: 19/07/2022 -
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Human cell-based medicinal products - Scientific guideline
Last updated: 21/05/2008