62 results
Keyword Phentermine 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: 13/06/2013Refused phenterminetopiramate Overview On 18 October 2012 … contains the active substances phentermine and topiramate. It was to … are appetite suppressants. Phentermine suppresses appetite by releasing … -
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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, -gynacology-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: XKey facts phentermine topiramate Endocrinology … granting of a waiver for phentermine / topiramate, (EMEA-000 … granting of a waiver for phentermine / topiramate, (EMEA-000826-PIP01-09 … -
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Referral: Anorectics
phentermine, amfepramome, clobenzorex, dexfenfluramine, fenbutrazate, fenfluramine, fenproporex, mazindol, mefenorex, norpseudoephedrine, phenmetrazine, phendimetrazine, propylhexedrine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/02/1996, EC decision date: 09/12/1996, Last updated: 10/12/1996Phendimetrazine, Phenmetrazine, Phentermine • Type II Substances: Dexfenfluramine … 108), Phenmetrazine (109), Phentermine (103) 1/2 Annex I AMENDMENTS … phentermine amfepramome clobenzorex de … -
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Referral: Topiramate
topiramate, Article 31 referrals
Status: Under evaluation, Last updated: 02/12/2022countries, in combination with phentermine for body weight reduction … fixed-dose combination with phentermine. Topiramate is available in … available in combination with phentermine as Qsiva. More about the … -
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News: PRAC starts review of topiramate use in pregnancy and women of childbearing potential
PRAC, Last updated: 02/09/2022countries, in combination with phentermine for body weight reduction … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2012
CHMP, Last updated: 19/10/2012INN phentermine / topiramate Marketing-authorisation … -
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Human medicine European public assessment report (EPAR): Striascan
ioflupane (123l), Radionuclide Imaging; Dementia; Movement Disorders
Date of authorisation: 25/06/2019,
, Revision: 2, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Sunosi
solriamfetol hydrochloride, Narcolepsy; Sleep Apnea, Obstructive
Date of authorisation: 16/01/2020,
, Revision: 7, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Nouryant
Istradefylline, Parkinson Disease
Date of refusal: 06/01/2022, Refused, Last updated: 19/01/2022 -
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Human medicine European public assessment report (EPAR): Imcivree
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,, 
, Revision: 5, Authorised, Last updated: 22/11/2022
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Human medicine European public assessment report (EPAR): Celsunax
ioflupane (123i), Radionuclide Imaging; Dementia; Movement Disorders
Date of authorisation: 17/06/2021,, Authorised, Last updated: 02/07/2021
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Human medicine European public assessment report (EPAR): DaTSCAN
ioflupane (123l), Tomography, Emission-Computed, Single-Photon; Lewy Body Disease; Parkinson Disease; Alzheimer Disease
Date of authorisation: 27/07/2000, Revision: 23, Authorised, Last updated: 10/02/2022 -
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Human medicine European public assessment report (EPAR): Fintepla
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Revision: 3, Authorised, Last updated: 26/07/2022
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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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Human medicine European public assessment report (EPAR): Xenical
orlistat, Obesity
Date of authorisation: 29/07/1998, Revision: 24, Authorised, Last updated: 07/05/2020 -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 February 2013
CHMP, Last updated: 22/02/2013Qsiva INN phentermine / topiramate Marketing-authorisation … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022
PRAC, Last updated: 02/09/2022countries, in combination with phentermine for body weight reduction … Topiramate (NAP); topiramate, phentermine (NAP) - EMEA/H/A-31/1520 … -
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Withdrawn application: Imcivree
setmelanotide, date of withdrawal: 22/04/2022, Post-authorisation, Last updated: 28/09/2022 -
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Referral: Amfepramone-containing medicinal products (updated)
amfepramone, associated names: Regenon, Tenuate Retard, Amfepramon-Hormosan, Regenon Retard, Article 31 referrals
Status: European Commission final decision, opinion/position date: 10/11/2022, EC decision date: 13/01/2023, Last updated: 20/01/2023 -
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Referral: Efexor depot
venlafaxine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/07/2008, EC decision date: 28/11/2008, Last updated: 20/12/2008 -
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Referral: Efexor
venlafaxine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/07/2008, EC decision date: 28/11/2008, Last updated: 18/12/2008 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 November - 1 December 2022
European Medicines Agency, Amsterdam, the Netherlands, from 28/11/2022 to 01/12/2022, Last updated: 29/11/2022Topiramate (NAP); topiramate, phentermine (NAP) - EMEA/H/A-31/1520 … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 29 August - 1 September 2022
European Medicines Agency, Amsterdam, the Netherlands, from 29/08/2022 to 01/09/2022, Last updated: 02/09/2022Topiramate (NAP); topiramate, phentermine (NAP) - EMEA/H/A-31/1520 … -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 18/01/2023Topiramate (NAP); topiramate, phentermine (NAP) - EMEA/H/A-31/1520 …
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-5 September 2012
European Medicines Agency, London, UK, from 03/09/2012 to 05/09/2012, Last updated: 02/06/2012