31 results
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Referral: Protium
pantoprazole, associated names: Anagastra, Apton, Controloc, Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20 / 40 / IV, Pantoc, Pantoloc, PantoLomberg, Pantopan, Pantorc, Pantozol, Peptazol, Rifun, Somac, Ulcotenal, Zurcal, Zurcale, Zurcazol, Article 30 referrals
Status: European Commission final decision, opinion/position date: 17/12/2009, EC decision date: 15/04/2010, Last updated: 17/01/2012Pantoprazol-Byk, Pantoprazole ALTANA, Pantoprazole Lomberg, Pantorc … Pantoprazol-Byk, Pantoprazole ALTANA, Pantoprazole Lomberg, Pantorc … -
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National expert: Christian Gartner, Austrian Agency for Health and Food Safety (updated)
- Declaration of interests - 40.15 KB | PDF
- Curriculum Vitae - 31.51 KB | PDF
Clinical Trial Management 3. ALTANA Pharma AG (07/2002-09/2006 … employments at AMS Mannheim GmbH, ALTANA Pharma AG, Intercell AG … member: AMS Mannheim GmbH, ALTANA Pharma AG, Intercell AG … -
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Referral: Alvesco
ciclesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/03/2008, EC decision date: 11/07/2008, Last updated: 05/08/2008hydrofluoroalkane-134A as a propellant. Altana Pharma AG submitted applications … hydrofluoroalkane-134A as a propellant. Altana Pharma AG submitted applications … Inhalation use Bulgaria ALTANA Pharma AG Byk-Gulden-Str … -
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Orphan designation: Lusupultide for: Treatment of aspiration pneumonitis requiring intubation and mechanical ventilation
Date of designation: 10/07/2007, Withdrawn, Last updated: 15/10/2009the European Commission to ALTANA Pharma AG, Germany, for lusupultide … the European Commission to ALTANA Pharma AG, Germany, for lusupultide … -
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Orphan designation: Lusupultide for: Treatment of acute respiratory distress syndrome (ARDS)
Date of designation: 17/01/2001, Withdrawn, Last updated: 15/05/2009Fabrik GmbH changed name to ALTANA Pharma AG in September 2002 … Fabrik GmbH changed name to ALTANA Pharma AG in September 2002 … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,17-19 March 2008
CHMP, Last updated: 20/03/2008inhaler (ciclesonide), from Altana Pharma AG, for the treatment … -
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National expert: Guy Berchem, Ministry Of Health (updated)
- Declaration of interests - 47.67 KB | PDF
- Curriculum Vitae - 55.63 KB | PDF
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Withdrawn application: Sliwens
date of withdrawal: 18/12/2009, Initial authorisation, Last updated: 01/06/2010 -
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Herbal medicinal product: Citri bergamiae aetheroleum
Citrus bergamia Risso & Poiteau., Bergamot oil, F: Assessment finalised, Last updated: 29/11/2021 -
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Referral: Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome
terlipressin, Article 31 referrals
Status: CMDh final position, opinion/position date: 10/11/2022, Last updated: 22/11/2022 -
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Referral: Pantoprazole Bluefish
pantoprazole, associated names: Pantecta, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/11/2009, EC decision date: 30/03/2010, Last updated: 09/03/2011 -
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Referral: Pantoprazole Olinka (EMEA/H/A-29/1169)
pantoprazole, associated names: Pantecta, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/11/2009, EC decision date: 30/03/2010, Last updated: 08/03/2011Pantecta 40 mg developed by Altana Pharma AG, Spain. During … -
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Referral: Pantoprazole Olinka (EMEA/H/A-29/1170)
pantoprazole, associated names: Pantecta, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/11/2009, EC decision date: 30/03/2010, Last updated: 08/03/2011Pantecta 40 mg developed by Altana Pharma AG, Spain. During … -
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Direct healthcare professional communication (DHPC): Arti-Cell® Forte and RenuTend® market recall of select product batches
Active substance: Equine allogeneic mesenchymal stem cells, DHPC type: Quality defect, Last updated: 04/05/2023References: 1. Altan, E., Li, Y., Sabino-Santos … -
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Referral: Injectable veterinary medicinal products containing vitamin A for use in food producing species
Vitamin A (retinol and its esters), Article 35
Status: European Commission final decision, opinion/position date: 12/05/2021, EC decision date: 18/08/2021, Last updated: 27/09/2021 -
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Referral: Loratadine
loratadine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/11/2003, EC decision date: 28/04/2004, Last updated: 14/07/2004 -
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Referral: Calcitonins
calcitonin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/11/2002, EC decision date: 12/06/2003, Last updated: 02/03/2004 -
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Referral: Gadolinium-containing contrast agents
gadodiamide, gadopentetic acid, gadobenic acid, gadoxetic acid, gadoteridol, gadobutrol, gadoteric acid, associated names: Omniscan, Magnevist, Magnegita, Gado-MRT ratiopharm, Primovist, MultiHance, Dotarem, ProHance, Gadovist, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 06/12/2010 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Press release: Committee for Orphan Medicinal Products: May 2008 meeting
COMP, Last updated: 16/05/2007• Lusupultide, from ALTANA Pharma AG, for treatment … -
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Evaluation of Medicinal Products in Children, Forth European Course
Brussels, Belgium, from 10/02/2006 to 12/02/2006, Last updated: 12/02/2006 -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,12-15 November 2007
CHMP, Last updated: 16/11/2007 -
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Annual reports and work programmes (updated)
Last updated: 15/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 23-26 April 2018
European Medicines Agency, London, UK, from 23/04/2018 to 26/04/2018, Last updated: 08/06/2018 -
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Guidance documents
Last updated: 19/07/2022