52 results
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Opinion/decision on a Paediatric investigation plan (PIP): Mirapexin, pramipexole dihydrochloride monohydrate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: Pramipexole dihydrochloride monohydrate, Route(s) of administration: Oral use, Pharmaceutical form(s): Immediate Release Tablet
Decision date: 12/09/2008, Last updated: 10/10/2008, Compliance check: XInvented name Mirapexin Active substance pramipexole … dihydrochloride monohydrate, (Mirapexin) (EMEA-000080-PIP01-07) in … dihydrochloride monohydrate, (Mirapexin) (EMEA-000080-PIP01-07)in … -
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Human medicine European public assessment report (EPAR): Mirapexin
pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease
Date of authorisation: 23/02/1998, Revision: 38, Authorised, Last updated: 28/09/2021Mirapexin Nervous System Diseases Sleep … Mirapexin … summary for the public Mirapexin pramipexole This document … -
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News: Public Statement onSifrol, Daquiran, Mirapexin (Pramipexole) - Sudden onset of sleep
Last updated: 19/07/1999Statement onSifrol, Daquiran, Mirapexin (Pramipexole) - Sudden onset … S.A. on 23 February 1998 for Mirapexin®. Pramipexole containing medicinal … are currently marketed as Mirapexin® in Greece, Italy, Spain and … -
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News: Public Statement on Sifrol, Daquiran, Mirapexin (Pramipexole) - Recommendation to Reinforce the Warningon the sudden onset of sleep
Last updated: 03/08/1999Statement on Sifrol, Daquiran, Mirapexin (Pramipexole) - Recommendation … S.A. on 23 February 1998 for Mirapexin®. Pramipexole is one of the … are currently marketed as Mirapexin® in Greece, Italy, Spain and … -
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Human medicine European public assessment report (EPAR): Pramipexole Accord
pramipexole dihydrochloride monohydrate, Parkinson Disease; Restless Legs Syndrome
Date of authorisation: 29/09/2011,
, Revision: 10, Authorised, Last updated: 11/12/2020
European Union (EU) called Mirapexin. What is Pramipexole Accord … to the reference medicine, Mirapexin. Two medicines are bioequivalent … and to be bioequivalent to Mirapexin. Therefore, the CHMP’s view … -
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Human medicine European public assessment report (EPAR): Oprymea
pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 12/09/2008,, Revision: 21, Authorised, Last updated: 22/02/2022
called Sifrol (also known as Mirapexin). How is Oprymea used? Oprymea … called Sifrol (also known as Mirapexin). For more information on generic … -
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Human medicine European public assessment report (EPAR): Pramipexole Teva
pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 18/12/2008,, Revision: 22, Authorised, Last updated: 23/11/2021
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Human medicine European public assessment report (EPAR): Sifrol
pramipexole dihydrochloride monohydrate, Restless Legs Syndrome; Parkinson Disease
Date of authorisation: 13/10/1997, Revision: 35, Authorised, Last updated: 04/10/2021 -
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Human medicine European public assessment report (EPAR): Viramune (updated)
nevirapine, HIV Infections
Date of authorisation: 04/02/1998, Revision: 42, Authorised, Last updated: 07/06/2022 -
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Human medicine European public assessment report (EPAR): Aptivus
tipranavir, HIV Infections
Date of authorisation: 25/10/2005, Revision: 41, Authorised, Last updated: 28/03/2022 -
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Human medicine European public assessment report (EPAR): Twynsta
telmisartan, amlodipine, Hypertension
Date of authorisation: 07/10/2010, Revision: 12, Authorised, Last updated: 10/01/2022 -
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Human medicine European public assessment report (EPAR): Trajenta
linagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 23/08/2011, Revision: 18, Authorised, Last updated: 04/01/2022 -
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Human medicine European public assessment report (EPAR): Daquiran
pramipexole dihydrochloride monohydrate, Parkinson Disease
Date of authorisation: 27/10/1997, Revision: 5, Withdrawn, Last updated: 23/05/2006pramipexole i.e. Sifrol and Mirapexin. On 2 February 2006 the … -
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Human medicine European public assessment report (EPAR): Onduarp
telmisartan, Hypertension
Date of authorisation: 24/11/2011, Revision: 2, Withdrawn, Last updated: 02/04/2014 -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2011
CHMP, Last updated: 22/07/2011Pramipexole Accord is a generic of Mirapexin. … Pramipexole Accord is a generic of Mirapexin. • Telmisartan Teva Pharma … -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of designation: 22/05/2006, Expired, Last updated: 25/11/2021 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of designation: 27/07/2005, Positive, Last updated: 14/06/2021 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of designation: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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Committee for Medicinal Products for Human Use (CHMP): 8-11 November 2021
Online, from 08/11/2021 to 11/11/2021, Last updated: 20/01/2022 -
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 17/06/2022 -
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Download medicine data
Last updated: 02/12/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 9-12 November 2020
Virtual meeting, from 09/11/2020 to 12/11/2020, Last updated: 07/01/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 October 2020
Virtual meeting, from 26/10/2020 to 29/10/2020, Last updated: 08/01/2021 -
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Committee for Medicinal Products for Human Use (CHMP): 14-17 September 2020
Virtual meeting, from 14/09/2020 to 17/09/2020, Last updated: 10/03/2021 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 2-5 December 2013
European Medicines Agency, London, UK, from 02/12/2013 to 05/12/2013, Last updated: 02/07/2012