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Herbal medicinal product: Sabalis serrulatae fructus
Serenoa repens (W.Bartram) Small (syn. Sabal serrulata (Michx.) Schult.f.), Saw Palmetto Fruit, F: Assessment finalised, Last updated: 16/09/2021plant Serenoa repens (W. Bartram) Small. Saw palmetto fruit … fruit Serenoa repens (W. Bartram) Small, fructus This is … plant Serenoa repens (W. Bartram) Small. Saw palmetto fruit … -
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National expert: Monica Bartolomei, Italian Medicines Agency (updated)
- Declaration of interests - 39.46 KB | PDF
- Curriculum Vitae - 33.4 KB | PDF
Monica Bartolomei … Monica Bartolomei … Vitae Personal information Monica Bartolomei Work experience … -
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National expert: Immanuel Barth, Paul-Ehrlich-Institut (updated)
- Declaration of interests - 39.22 KB | PDF
- Curriculum Vitae - 24.03 KB | PDF
Immanuel Barth … Immanuel Barth … Vitae Personal information Immanuel Barth Work experience … -
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National expert: Maria Bartolo, National Organization For Medicines (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 23.14 KB | PDF
Maria Bartolo … Maria Bartolo … Vitae Personal information Maria Bartolo Work experience … -
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National expert: Birgit Barten, European Medicines Agency (updated)
- Declaration of interests - 39.85 KB | PDF
- Curriculum Vitae - 23.51 KB | PDF
Birgit Barten … Birgit Barten … Vitae Personal information Birgit Barten Work experience … -
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National expert: Jens Barthel, Federal Office Of Consumer Protection And Food Safety (updated)
- Declaration of interests - 39.42 KB | PDF
- Curriculum Vitae - 23.21 KB | PDF
Jens Barthel … Jens Barthel … Vitae Personal information Jens Barthel Work experience … -
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National expert: Miriam Bartolo, Medicines Authority (updated)
- Declaration of interests - 39.99 KB | PDF
- Curriculum Vitae - 27.88 KB | PDF
Miriam Bartolo … Miriam Bartolo … Vitae Personal information Miriam Bartolo Work experience … -
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National expert: Grit Barthel, Federal Office Of Consumer Protection And Food Safety (updated)
- Declaration of interests - 39.19 KB | PDF
- Curriculum Vitae - 25.35 KB | PDF
Grit Barthel … Grit Barthel … Vitae Personal information Grit Barthel Work experience … -
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National expert: Bart Denayer, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 24.47 KB | PDF
Bart Denayer … Bart Denayer … Vitae Personal information Bart Denayer Work experience … -
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National expert: Eva Maria Bartos Roth, National Institute of Pharmacy and Nutrition (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 22.12 KB | PDF
Eva Maria Bartos Roth … Eva Maria Bartos Roth … Vitae Personal information Eva Maria Bartos Roth Work experience … -
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National expert: Wilma Fischer-Barth, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 23.17 KB | PDF
Wilma Fischer-Barth … Wilma Fischer-Barth … information Wilma Fischer-Barth Work experience … -
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National expert: Bart de Keizer, Medicines Evaluation Board (updated)
- Declaration of interests - 40.35 KB | PDF
- Curriculum Vitae - 27.21 KB | PDF
Bart de Keizer … Bart de Keizer … Vitae Personal information Bart de Keizer Work experience … -
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National expert: Bart Van der Schueren, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 39.33 KB | PDF
- Curriculum Vitae - 41.56 KB | PDF
Bart Van der Schueren … Bart Van der Schueren … Vitae Personal information Bart Van der Schueren Work experience … -
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Orphan designation: Elamipretide for: Treatment of Barth syndrome
Date of designation: 20/05/2021, Positive, Last updated: 17/03/2022designation for the treatment of Barth syndrome … -
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Referral: Aprotinin
aprotinin, associated names: Trasylol, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 15/11/2007, EC decision date: 15/02/2008, Last updated: 22/11/2007results of a study called the BART study, which was looking … new information from the BART study into account. Since … study into account. Since the BART study is the first 'randomised' … -
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Referral: Antifibrinolytic medicines
aprotinin, aminocaproic acid, tranexamic acid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/06/2012, Last updated: 06/11/2013early results of a study (the BART study) that showed a higher … once final data from the BART study became available. The … data and analyses from the BART study and other sources that … -
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Press release: European Medicines Agency recommends lifting suspension of aprotinin
CHMP, Last updated: 17/02/2012found that the results of the BART study on which the suspension … preliminary results of the BART study, a randomised controlled … the final results of the BART study and looked at this … -
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Orphan designation: Nolatrexed for: Treatment of hepatocellular carcinoma
Date of designation: 02/10/2003, Withdrawn, Last updated: 23/02/2007Gemini House Bartholomew’s Walk Cambridgeshire Business … Research Ltd. Gemini House Bartholomew’s Walk Cambridgeshire Business … -
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Press release: European Medicines Agency recommends suspension of marketing authorisation of aprotinin-containing medicines for systemic use
CHMP, Last updated: 21/11/2007interim results from the BART clinical trial, showing increased … preliminary results from the BART study as well as at the results … the final results of the BART study. The CHMP opinion will … -
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Press release: EMEA celebrates 10th anniversary
Last updated: 14/03/2005Health Minister, Mars Di Bartolomeo, and European Parliament Vice-President … Health Minister, Mars Di Bartolomeo, and European Parliament … -
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Quality Working Party
Last updated: 31/12/2009Luisa Arreaza Lopez Miriam Bartolo Jens-Uwe Bleich Silvia Cârstoiu … Carvalho Ferreira Ruth Demarco Bart Denayer Ines Dias Diyana …
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Orphan designation: Recombinant protein consisting of modified human growth hormone releasing hormone and the translocation and endopeptidase domains of botulinum toxin serotype D for: Treatment of acromegaly
Date of designation: 11/01/2012, Withdrawn, Last updated: 23/05/2019Units 4-10 The Quadrant Barton Lane Abingdon OX14 3YS United … -
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Orphan designation: Adeno-associated viral vector serotype 5 containing the human CHM gene for: Treatment of choroideraemia
Date of designation: 24/04/2015, Positive, Last updated: 16/08/2017 -
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2006 EMEA/EFPIA Workshop on Biomarkers
London, 16/12/2006, Last updated: 16/12/2006position paper proposals - Geoff Barton PDF icon application/pdf … Eli Lilly 15.15 Dr Geoff Barton EFPIA position paper proposals … -
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Press release: Invitation to EMEA 10th anniversary celebrations 11 March 2005
Last updated: 02/03/2005speakers include Mars di Bartolomeo (Luxembourg Minister of Health … speakers include Mars di Bartolomeo (Luxembourg Minister of Health …