24 results
Keyword Lasix Fiale Remove keyword
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Orphan designation: Refusal of orphan designation for the treatment of cystic fibrosis
Date of refusal of designation: 16/07/2010, Negative, Last updated: 09/08/2010Telefax: +45 43 58 37 69 E-mail: fiala@serendex.com Documents related to this … 45 43 58 37 69 E-mail: fiala@serendex.com Patient associations’ … -
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National expert: Peter Potúček, State Institute for Drug Control (updated)
- Declaration of interests - 80.31 KB | PDF
- Curriculum Vitae - 17.27 KB | PDF
Pharmaceuticae, 66(2), 32-36. Fialova, S., Tekelova, D., Svajdlenka … -
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National expert: Jaroslav Tóth, State Institute for Drug Control (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 25.1 KB | PDF
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National expert: Christine Vaculik, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 19.14 KB | PDF
Schuster C, Vaculik C., Prior M, Fiala C, Mildner M, Eppel W, Stingl … Schuster C., Vaculik C., Fiala C., Meindl S., Brandt O … -
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Human medicine European public assessment report (EPAR): Zutectra
human hepatitis B immunoglobulin, Immunization, Passive; Hepatitis B; Liver Transplantation
Date of authorisation: 30/11/2009, Revision: 15, Authorised, Last updated: 31/08/2022 -
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Human medicine European public assessment report (EPAR): Velphoro
Sucroferric oxyhydroxide, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 26/08/2014, Revision: 9, Authorised, Last updated: 08/12/2022 -
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National expert: Lukas Slovak, State Institute for Drug Control (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 33.21 KB | PDF
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,
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, Revision: 35, Authorised, Last updated: 03/02/2023
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Human medicine European public assessment report (EPAR): Revatio
sildenafil, Hypertension, Pulmonary
Date of authorisation: 28/10/2005, Revision: 48, Authorised, Last updated: 25/08/2022 -
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National expert: Lise Lotte Gluud, Danish Medicines Agency (updated)
- Declaration of interests - 81.78 KB | PDF
- Curriculum Vitae - 41.46 KB | PDF
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National expert: Michael Denkinger, European Medicines Agency (updated)
- Declaration of interests - 80.81 KB | PDF
- Curriculum Vitae - 54.14 KB | PDF
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National expert: Robin Ristl, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 80.93 KB | PDF
- Curriculum Vitae - 44.36 KB | PDF
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National expert: Loreto Carmona, European Medicines Agency (updated)
- Declaration of interests - 81.42 KB | PDF
- Curriculum Vitae - 108.52 KB | PDF
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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: 02/03/200437 IT-50143 Firenze Calciben Fiale 50 IU Solution for injection … Ampoule 1 ml 5 Calciben Fiale 100 IU Solution for injection … 20,5 IT-21040 Origgio Miacalcic 50 Fiale 50 IU Solution for injection … -
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Referral: Zinc oxide
zinc oxide, Article 35
Status: European Commission final decision, opinion/position date: 16/03/2017, EC decision date: 26/06/2017, Last updated: 14/08/2017 -
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National expert: Paola Minghetti, Italian Medicines Agency (updated)
- Declaration of interests - 81.41 KB | PDF
- Curriculum Vitae - 62.13 KB | PDF
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National expert: Mirko Petrovic, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.27 KB | PDF
- Curriculum Vitae - 111.08 KB | PDF
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Public data from Article 57 database
Last updated: 17/10/2022 -
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European Union regulatory workshop on medication errors
European Medicines Agency, London, UK, from 28/02/2013 to 01/03/2013, Last updated: 13/05/2013 -
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Homeopathic Workshop
London, 27/10/2006, Last updated: 01/10/2006 -
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News: Safer use of medicines by preventing medication errors
Last updated: 27/11/2015 -
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News: Preventing medication errors in the European Union
Last updated: 14/04/2015 -
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Guidance documents
Last updated: 19/07/2022 -
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EudraVigilance: electronic reporting
Last updated: 15/02/2022