13 results
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Referral: Lipitor
atorvastatin, associated names: Atorvastatin, Atorvastatina Nostrum, Atorvastatina Parke-Davis, Atorvastatina Pharmacia, Cardyl, Edovin, Liprimar, Orbeos, Prevencor, Sortis, Tahor, Texzor, Torvast, Totalip, Xarator, Zarator, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/09/2010, EC decision date: 13/12/2010, Last updated: 10/04/2012Prevencor, Sortis, Tahor, Texzor, Torvast, Totalip, Xarator and Zarator … Prevencor, Sortis, Tahor, Texzor, Torvast, Totalip, Xarator and Zarator … -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011Atorvastatina Edovin Obradon Xarator Torvast Totalip Texzor Cardyl Prevencor … -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011Atorvastatina Edovin Obradon Xarator Torvast Totalip Texzor Cardyl Prevencor … -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011Atorvastatina Edovin Obradon Xarator Torvast Totalip Texzor Cardyl Prevencor … -
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Referral: Singulair
montelukast, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/04/2008, EC decision date: 11/07/2008, Last updated: 05/08/2008 -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin calcium
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: Atorvastatin calcium, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 20/07/2008, Last updated: 08/09/2008, Compliance check: V, 13/11/2009 -
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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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Deadlines for placing paediatric medicines on the market
Last updated: 10/08/2015Zarator, Liprimar, Totalip, Torvast, Cardyl EMEA-000073-PIP01-07 …
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Public data from Article 57 database
Last updated: 30/06/2023 -
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Guidance documents
Last updated: 19/07/2022