598 results
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fc receptor human monoclonal antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002559-PIP01-19, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: XContact for public enquiries Momenta Pharmaceuticals, Inc. E-mail: … -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fc receptor human monoclonal antibody
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002559-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion
Decision date: 18/03/2020, Last updated: 29/07/2020, Compliance check: XContact for public enquiries Momenta Pharmaceuticals, Inc. E-mail: … -
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Veterinary medicine European public assessment report (EPAR): Suprelorin
deslorelin acetate, Dogs, Ferrets
Date of authorisation: 10/07/2007, Revision: 13, Authorised, Last updated: 22/04/2020needle is shielded until the moment of implantation. In case … needle is shielded until the moment of implantation. In case … -
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News: Speeding up development of Ebola treatments and vaccines
Last updated: 20/10/2014concern worldwide. At the moment, there are no approved medicines … -
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Press release: European Medicines Agency implements internal reorganisation
Last updated: 05/10/2009of staff members. For the moment, there will be minimal changes … of staff members. For the moment, there will be minimal changes … -
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Press release: Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments
Last updated: 19/03/2020countries in these trials. At the moment, there are no approved medicines … -
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Press release: EMA starts rolling review of remdesivir for COVID-19
Last updated: 30/04/2020cannot be anticipated at this moment, it is expected that this … -
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Mutual reliance between the United States Food and Drug Administration and the European Union on good-manufacturing-practice inspections
European Medicines Agency, London, UK, from 14/11/2014 to 17/11/2014, Last updated: 14/11/2014but there is now renewed momentum on this issue. Representatives … -
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National expert: Anneli Lauhio, Finnish Medicines Agency (updated)
- Declaration of interests - 80.43 KB | PDF
- Curriculum Vitae - 28.62 KB | PDF
Turku/Finland). Also at the moment an academic study project … Government, Finland. At the moment I belong to some working/expert … -
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National expert: Mauro Picardo, Italian Medicines Agency (updated)
- Declaration of interests - 81.91 KB | PDF
- Curriculum Vitae - 0 bytes | PDF
modulators in vitro none at the moment 07/2017-(current) PPM service … octatrienoic none at the moment Picardo 2020-12-10 2 Classified … -
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News: End of year message from EMA's Executive Director
Last updated: 21/12/20172017 I would like to take a moment to thank all our partners … -
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News: EMA launches checklist to facilitate validation for initial marketing authorisation applications
Last updated: 08/02/2019potential delays at a critical moment for the timely start of the … -
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Press release: EMA ready to start assessment of Ebola vaccines and treatments as soon as data are made available
Last updated: 22/10/2014spread of the disease. At the moment, there are no approved medicines … spread of the disease. At the moment, there are no approved medicines … -
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Press release: Ebola outbreak: EMA to review experimental medicines to support treatment decisions
Last updated: 26/09/2014health authorities. At the moment, there are no approved medicines … health authorities. At the moment, there are no approved medicines … -
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PSUR roadmap: joint industry/assessor training
European Medicines Agency, London, UK, 22/09/2017, Last updated: 18/10/2017Please take a moment to provide your feedback … the training, please take a moment to provide your feedback … -
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News: EMA encourages tailored development of medicines for older people
Last updated: 01/08/2017the name of the day or the moment when a medicine needs to … -
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Orphan designation: 2-Methoxy-5-[(1Z)-2-(3,4,5-trimethoxyphenyl)ethenyl]-phenol (fosbretabulin tromethamine) for: Treatment of anaplastic thyroid cancer
Date of first decision: 14/04/2004, Positive, Last updated: 19/02/2020such as the lungs, at the moment of diagnosis. Anaplastic … such as the lungs, at the moment of diagnosis. Anaplastic … -
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Orphan designation: L-threo-3,4-dihydroxyphenylserine for: Treatment of orthostatic hypotension in patients with pure autonomic failure
Date of first decision: 02/08/2007, Positive, Last updated: 09/02/2016which causes dizziness or momentary blackouts. The condition … which causes dizziness or momentary blackouts. The condition … -
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Orphan designation: L-threo-3,4-dihydroxyphenylserine for: Treatment of orthostatic hypotension in patients with multiple system atrophy
Date of first decision: 02/08/2007, Positive, Last updated: 09/02/2016which causes dizziness or momentary blackouts. The condition … which causes dizziness or momentary blackouts. The condition … -
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Press release: European Medicines Agency gives new temporary treatment recommendations for Fabrazyme
Last updated: 23/04/2010urinary GL-3 levels, as for the moment the GL-3 level is the most … -
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Press release: Supply shortage of Fabrazyme – updated treatment recommendations required for adult male patients
Last updated: 25/09/2009urinary GL-3 levels, as for the moment the GL-3 level is the most … -
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National expert: Cinzia Cupani, Italian Medicines Agency (updated)
- Declaration of interests - 79.74 KB | PDF
- Curriculum Vitae - 17.89 KB | PDF
in neuropsichiatria Editor Momento Medico. 2009 2.Cooperation … -
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National expert: Marko Korenjak, European Medicines Agency (updated)
- Declaration of interests - 80.69 KB | PDF
- Curriculum Vitae - 18.15 KB | PDF
organization. At present moment I manage two teams team … -
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National expert: Toni Mathieson, European Medicines Agency (updated)
- Declaration of interests - 80.46 KB | PDF
- Curriculum Vitae - 17.29 KB | PDF
how it progresses. At the moment registries are typically … -
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National expert: Kristl Claeys, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 84.19 KB | PDF
- Curriculum Vitae - 17.1 KB | PDF
Indication 09/2018-(current) Momenta Pharmaceuticals A Phase 2 …