47 results
Keyword Galantamine Remove keyword
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Referral: Galantamine Stada
galantamine, associated names: Galantamina, Galantamine Tiefenbacher, Galantamina Ciclum, Galatnax xl, Galastad, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/09/2010, EC decision date: 21/02/2011, Last updated: 08/06/2012Galantamine Stada … authorisation of the medicine Galantamine Stada. The Agency's Committee … concluded that the benefits of Galantamine Stada do not outweigh its … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 20-23 September 2010
CHMP, Last updated: 24/09/2010Galantamine Stada … -
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National expert: Guillermo Garcia Ribas, European Medicines Agency (updated)
- Declaration of interests - 82.81 KB | PDF
- Curriculum Vitae - 21.7 KB | PDF
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National expert: Rob van Marum, European Medicines Agency (updated)
- Declaration of interests - 79.89 KB | PDF
- Curriculum Vitae - 39.16 KB | PDF
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Human medicine European public assessment report (EPAR): Vizamyl
flutemetamol (18F), Radionuclide Imaging; Alzheimer Disease
Date of authorisation: 22/08/2014, Revision: 14, Authorised, Last updated: 21/12/2022 -
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Human medicine European public assessment report (EPAR): Ebixa
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 15/05/2002, Revision: 26, Authorised, Last updated: 05/01/2022 -
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Human medicine European public assessment report (EPAR): Memantine Merz
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 22/11/2012, Revision: 7, Authorised, Last updated: 20/04/2022 -
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Human medicine European public assessment report (EPAR): Memantine ratiopharm
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 12/06/2013,, Revision: 8, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Memantine Mylan
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 21/04/2013,, Revision: 9, Authorised, Last updated: 17/10/2022
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Human medicine European public assessment report (EPAR): Axura
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 17/05/2002, Revision: 26, Authorised, Last updated: 12/05/2021 -
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Human medicine European public assessment report (EPAR): Memantine Accord
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 03/12/2013,, Revision: 7, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Nemdatine
memantine, Alzheimer Disease
Date of authorisation: 22/04/2013,
Date of refusal: 22/02/2013,, Revision: 11, Authorised, Last updated: 07/07/2022
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Human medicine European public assessment report (EPAR): Okedi
Risperidone, Schizophrenia
Date of authorisation: 14/02/2022, Revision: 1, Authorised, Last updated: 01/08/2022 -
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Human medicine European public assessment report (EPAR): Balaxur
memantine hydrochloride, donepezil hydrochloride, Alzheimer Disease
Date of refusal: 20/02/2013, Refused, Last updated: 11/03/2013 -
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Human medicine European public assessment report (EPAR): Acrescent
memantine hydrochloride, donepezil hydrochloride, Alzheimer Disease
Date of refusal: 20/02/2013, Refused, Last updated: 11/03/2013 -
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Human medicine European public assessment report (EPAR): Marixino (previously Maruxa)
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 28/04/2013,, Revision: 8, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Xadago
safinamide methanesulfonate, Parkinson Disease
Date of authorisation: 23/02/2015, Revision: 12, Authorised, Last updated: 26/10/2021 -
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Human medicine European public assessment report (EPAR): Amyvid
florbetapir (18F), Radionuclide Imaging
Date of authorisation: 14/01/2013, Revision: 14, Authorised, Last updated: 31/03/2021 -
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National expert: Astrid Thomas, European Medicines Agency (updated)
- Declaration of interests - 79.97 KB | PDF
- Curriculum Vitae - 55.73 KB | PDF
Felbamate, FP0011, FP0153, Galantamine, Impax, Istradefilina, Lamotrigina … -
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Withdrawn application: Aduhelm
aducanumab, date of withdrawal: 20/04/2022, Initial authorisation, Last updated: 01/08/2022 -
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Withdrawn application: Memantine FGK
memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013 -
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Referral: Risperdal Consta
risperidone, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/07/2008, EC decision date: 07/10/2008, Last updated: 22/10/2008 -
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Referral: Risperdal
risperidone, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/07/2008, EC decision date: 07/10/2008, Last updated: 13/11/2008 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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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