182 results
Keyword Topiramate Remove keyword
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Human medicine European public assessment report (EPAR): Qsiva
phentermine, topiramate, Obesity
Date of refusal: 14/05/2013, Refused, Last updated: 13/06/2013substances phentermine and topiramate. It was to be available as … brain that controls hunger. Topiramate is thought to act by increasing … exact mechanisms of action of topiramate are not fully understood … -
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Referral: Topiramate (updated)
topiramate, Article 31 referrals
Status: CMDh final position, opinion/position date: 10/11/2023, Last updated: 23/11/2023Topiramate … New measures to avoid topiramate exposure in pregnancy … New measures to avoid topiramate exposure in pregnancy Further … -
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Referral: Topamax
topiramate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/06/2009, EC decision date: 01/10/2009, Last updated: 15/12/2009headaches. The exact way in which topiramate, the active substance in Topamax … names: Topimax, Epitomax, Topiramat-Cilag, Topiramat-Janssen, Topamax Migräne and Topamac … Topamax and associated names topiramate tablets and capsules … -
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Direct healthcare professional communication (DHPC): Topiramate and topiramate/phentermine combination: New restrictions to prevent exposure during pregnancy (new)
Active substance: topiramate, phentermine, DHPC type: Restriction of indication, Last updated: 21/11/2023Topiramate and topiramate/phentermine combination: New restrictions … Documents Document details Topiramate and topiramate/phentermine combination: New restrictions … 21/11/2023 01/11/2023 Key facts topiramatephentermineEpilepsyMigraine DisordersEMEA/H/A-31/1520VariationRestriction … -
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Opinion/decision on a Paediatric investigation plan (PIP): phentermine, topiramate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: EMEA-000826-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 29/10/2010, Last updated: 25/11/2010, Compliance check: XActive substance phentermine topiramate Therapeutic area Endocrinology-Gynaecology-Fertility-Metabolism … waiver for phentermine / topiramate, (EMEA-000826-PIP01-09) in … waiver for phentermine / topiramate, (EMEA-000826-PIP01-09) in … -
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News: PRAC recommends new measures to avoid topiramate exposure in pregnancy
PRAC, Last updated: 01/09/2023recommends new measures to avoid topiramate exposure in pregnancy … avoid exposure of children to topiramate-containing medicines in the womb, because … exposure during pregnancy. Topiramate is already known to cause … -
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News: PRAC starts review of topiramate use in pregnancy and women of childbearing potential
PRAC, Last updated: 02/09/2022PRAC starts review of topiramate use in pregnancy and women … has started a review of topiramate and the risk of neurodevelopmental … whose mothers were taking topiramate during pregnancy Topiramate is a medicine used in the … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28-31 August 2023
PRAC, Last updated: 01/09/2023recommends new measures to avoid topiramate exposure in pregnancy EMA’s … avoid exposure of children to topiramate-containing medicines in the womb, because … exposure during pregnancy. Topiramate is already known to cause … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022
PRAC, Last updated: 02/09/202202/09/2022 PRAC starts review of topiramate use in pregnancy and women … has started a review of topiramate and the risk of neurodevelopmental … whose mothers were taking topiramate during pregnancy … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 July 2022
PRAC, Last updated: 08/07/2022neurodevelopmental disorders with topiramate … -
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Orphan designation: Cannabidiol for: Treatment of Lennox-Gastaut syndrome
Date of designation: 20/03/2017, Positive, Last updated: 14/06/2023lamotrigine, rufinamide, and topiramate. The sponsor has provided … lamotrigine, rufinamide, and topiramate. … -
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Orphan designation: Fenfluramine hydrochloride for: Treatment of Lennox-Gastaut syndrome
Date of designation: 27/02/2017, Positive, Last updated: 25/04/2023rufinamide, sodium valproate and topiramate. The sponsor has provided … rufinamide, sodium valproate and topiramate. … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023
PRAC, Last updated: 22/05/2023Procedure Status Update Topiramate – Article-31 referral Under … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9 February 2023
PRAC, Last updated: 10/02/2023referrals Procedure Status Update Topiramate – Article-31 referral Under … products: Article 31 referrals Topiramate: Article 31 referrals Related … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 January 2023
PRAC, Last updated: 13/01/2023referrals Procedure Status Update Topiramate – Article-31 referral Under … JAKi): Article 20 procedures Topiramate: Article 31 referrals Related … 14 3.2.1. Topiramate (NAP topiramate, phentermine (NAP) - EMEA/H/A-31/1520 … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5 - 8 June 2023
PRAC, Last updated: 09/06/2023Procedure Status Update Topiramate – Article-31 referral Under … 12 3.2.1. Topiramate (NAP topiramate, phentermine (NAP) - EMEA/H/A-31/1520 … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023
PRAC, Last updated: 14/04/2023referrals Procedure Status Update Topiramate – Article-31 referral Under … products: Article 31 referrals Topiramate: Article 31 referrals Pharmacovigilance … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3 - 6 July 2023
PRAC, Last updated: 07/07/2023referrals Procedure Status Update Topiramate – Article-31 referral Under … products: Article 31 referrals Topiramate: Article 31 referrals Pharmacovigilance … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2022
PRAC, Last updated: 02/12/2022referrals Procedure Status Update Topiramate – Article-31 referral Under … products: Article 107i procedures Topiramate: Article 31 referrals Related … 13 3.2.1. Topiramate (NAP topiramate, phentermine (NAP) - EMEA/H/A-31/1520 … -
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National expert: András Biro, National Center for Public Health and Pharmacy (updated)
- Declaration of interests - 41.24 KB | PDF
- Curriculum Vitae - 28.75 KB | PDF
Chromatographic Study of Topiramate and Its Impurities, Chromatographia … -
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European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop
European Medicines Agency, London, UK, from 30/11/2011 to 01/12/2011, Last updated: 30/04/2012 -
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National expert: Rebecca Bromley, European Medicines Agency (updated)
- Declaration of interests - 12.03 KB | PDF
- Curriculum Vitae - 54.9 KB | PDF
behaviour in children exposed to topiramate in the womb: An observational … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,27-30 May 2008
CHMP, Last updated: 02/06/2008topiramate), from Janssen-Cilag, used … as amended for Topamax (topiramate), from Janssen-Cilag, used … -
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Human medicine European public assessment report (EPAR): Ajovy (updated)
fremanezumab, Migraine Disorders
Date of authorisation: 28/03/2019,
, Revision: 10, Authorised, Last updated: 20/11/2023
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Human medicine European public assessment report (EPAR): Fycompa
perampanel, Epilepsies, Partial
Date of authorisation: 23/07/2012, Revision: 32, Authorised, Last updated: 31/10/2023