319 results
Keyword Aria Nippon Gases Remove keyword
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Medicinal gases: pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases)
Last updated: 09/07/2008Medicinal gases: pharmaceutical documentation … well established medicinal gases) … the quality of medicinal gases in the context of compiling …
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Press release: Euro Nippon Kayaku GmbH withdraws its marketing authorisation application for Spanidin (gusperimus)
CHMP, Last updated: 19/06/2008Euro Nippon Kayaku GmbH withdraws its … formally notified by Euro Nippon Kayaku GmbH of its decision … PRESS RELEASE Euro Nippon Kayaku GmbH withdraws its … -
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Quality: specific types of products
Last updated: 21/04/2016Medicinal gases: pharmaceutical documentation … well established medicinal gases) Pharmaceutical quality of …
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Development pharmaceutics
Last updated: 28/07/1998finished dosage form Medicinal gases: pharmaceutical documentation … well established medicinal gases) Need for a reflection paper …
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Non-clinical: toxicology
Last updated: 25/05/2016transcriptase inhibitors Medicinal gases: pharmaceutical documentation … well established medicinal gases) Genotoxic and carcinogenic …
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Orphan designation: Adrenomedullin for: Treatment of acute lung Injury
Date of designation: 09/06/2010, Positive, Last updated: 18/11/2011amounts of smoke or toxic gases, severe burns, near-drowning … amounts of smoke or toxic gases, severe burns, near-drowning … -
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Orphan designation: Human tumour necrosis factor alpha-derived peptide Cys-Gly-Gln-Arg-Glu-Thr-Pro-Glu-Gly-Ala-Glu-Ala-Lys-Pro-Trp-Tyr-Cys for: Treatment of acute lung Injury
Date of designation: 08/10/2009, Positive, Last updated: 20/10/2009amounts of smoke or toxic gases, severe burns, near-drowning … amounts of smoke or toxic gases, severe burns, near-drowning … -
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Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro for: Treatment of acute lung Injury
Date of designation: 10/10/2012, Withdrawn, Last updated: 19/01/2016amounts of smoke or toxic gases, severe burns, near-drowning … amounts of smoke or toxic gases, severe burns, near-drowning … -
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Mutual recognition agreements (MRA)
Last updated: 12/07/2019pharmaceuticals medicinal gases human biologicals, including …
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Press release: PRAC updates on the risks of serious vascular occlusive events associated with cancer medicine Iclusig
Last updated: 08/11/2013holder for this medicine is Ariad. Iclusig is an orphan medicinal … holder for this medicine is Ariad. 3. Iclusig is an orphan … -
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National expert: Olga Teresa Esteban, Spanish Agency of Medicines and Medical Devices
- Declaration of interests - 79.89 KB | PDF
- Curriculum Vitae - 17.03 KB | PDF
manufacture of medicines, medicinal gases. Publications Projects Memberships … of experts 9G (Medicinal Gases) EDQM. Member of the Committee … of experts 9G (Medicinal gases) and member of the Committee … -
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Orphan designation: Gusperimus trihydrochloride for: Treatment of Wegener's granulomatosis
Date of designation: 29/03/2001, Positive, Last updated: 18/11/2011European Commission to Euro Nippon Kajaku GmbH, Germany, for … European Commission to Euro Nippon Kajaku GmbH, Germany, for … -
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Orphan designation: 2-{4-[(5,6-Diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl)acetamide for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation: 26/08/2005, Withdrawn, Last updated: 12/02/2018the European Commission to Nippon Shinyaku Co. Ltd, Germany … the European Commission to Nippon Shinyaku Co. Ltd, Germany … -
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National expert: Petra Honl, Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 17.27 KB | PDF
radiopharmaceuticals, phytochemistry, medicinal gases, active substances, ATMPs GDP … radiopharmaceuticals, phytochemistry, medicinal gases, active substances GDP Inspections … -
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National expert: Jan Joseph, Austrian Medicines and Medical Devices Agency
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 17.19 KB | PDF
Respiration, as well for medical gases EDUCATION AND TRAINING January … Expert Group 9G (medicinal gases) since 2021 Publications … -
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2013 European Medicines Agency / International Federation for Animal Health Europe info day
European Medicines Agency, London, UK, from 07/03/2013 to 08/03/2013, Last updated: 08/04/2013– industry perspective (Ariane van de Moer) (PDF/203.13 KB … -
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National expert: Steffen Rex, Federal Agency for Medicines and Health Products
- Declaration of interests - 82.28 KB | PDF
- Curriculum Vitae - 44.82 KB | PDF
Matter Air Liquide Noble gases 2.8 Close family member … -
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National expert: Frank Straßberger, Federal Institute for Drugs and Medical Devices
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 16.83 KB | PDF
Pharmacopoeia (Chemistry, Medicinal Gases) Other Relevant Information 12/11/2021 … -
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Orphan designation: Molgramostim for: Treatment of acute respiratory distress syndrome (ARDS)
Date of designation: 27/06/2016, Positive, Last updated: 06/04/2022lines the airways and allows gases to pass easily between the … lines the airways and allows gases to pass easily between the … -
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National expert: Malgorzata Skiba, Chief Pharmaceutical Inspectorate
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 18.16 KB | PDF
parameters of compressed gases. 5. Preapartion of protocols … -
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Orphan designation: Ponatinib hydrochloride for: Treatment of gastrointestinal stromal tumours
Date of designation: 15/01/2015, Withdrawn, Last updated: 18/03/2022the European Commission to ARIAD Pharma Ltd, United Kingdom … the European Commission to ARIAD Pharma Ltd, United Kingdom … Sponsor’s contact details: ARIAD Pharma Ltd Riverbridge House … -
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National expert: Patrizia Iacovacci, Italian Medicines Agency
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 22.25 KB | PDF
Federico, M.E. Schinina, R. Ariano, G. Di Felice, C. Pini. Rapid … Iacovacci, R. Tinghino, R. Ariano, R.C. Panzani, G. Di Felice … Barletta, R. Tinghino, R. Ariano,R.C. Panzani, G. Di Felice, C … -
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National expert: Anne-Isabelle Waechter, National Agency For The Safety Of Medicine And Health Products
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 18.85 KB | PDF
A. INCHAUSTI, A. ROJAS DE ARIAS, R. HOCQUEMILLER ET A.-I … A. INCHAUSTI, A. ROJAS DE ARIAS, R. HOCQUEMILLER, A. CAVE … FERREIRA, A. FOURNET, A. ROJAS DE ARIAS, H. NAKAYAMA, S. TORRES, R … -
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National expert: Steffen Gross, Paul Ehrlich Institute
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 21.24 KB | PDF
Oncogene 18, 4069-79. Gross, S., Gase, K., and Malke, H. (1996 … -
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National expert: Fakhredin Sayed Tabatabaei, Medicines Evaluation Board
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 22.98 KB | PDF
HM, Verberne GJ, Visser FE, Arias-Vasquez A, Sayed-Tabatabaei FA, Vergeer-Drop …