101 results
Keyword Baclofen Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Baclofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Psychiatry
PIP number: EMEA-001549-PIP02-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 17/03/2017, Last updated: 21/04/2017, Compliance check: XKey facts Baclofen PsychiatryP/0085/2017EMEA-001549-PIP02-14 … granting of a waiver for baclofen (EMEA-001549-PIP02-14) PDF … granting of a waiver for baclofen (EMEA-001549-PIP02-14) in … -
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Orphan designation: R-baclofen for: Treatment of fragile X syndrome
Date of designation: 15/04/2011, Positive, Last updated: 26/04/2011R-baclofen Overview On 15 April 2011 … Ltd, United Kingdom, for R-baclofen for the treatment of fragile … affects brain function. R-baclofen activates a different type … -
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Orphan designation: (R-S) baclofen, naltrexone hydrochloride, D-sorbitol for: Treatment of Charcot-Marie-Tooth disease type 1A
Date of designation: 26/03/2014, Positive, Last updated: 16/07/2021R-S) baclofennaltrexone hydrochlorideD-sorbitol Overview … fixed-dose combination of (R-S) baclofen, naltrexone hydrochloride … of three substances: (R-S) baclofen, naltrexone hydrochloride … -
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Opinion/decision on a Paediatric investigation plan (PIP): (RS)-Bacoflen, D-Sorbitol (PXT3003), naltrexone hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002164-PIP01-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 29/01/2020, Last updated: 12/06/2020, Compliance check: Xinvestigation plan for (RS)-baclofen / Naltrexone HCl / D-Sorbitol … -
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Orphan designation: adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1 for: Treatment of amyotrophic lateral sclerosis
Date of designation: 16/04/2018, Positive, Last updated: 17/05/2018disease, such as treatment with baclofen as well as physiotherapy … different way to riluzole and baclofen and could lead to improvements … disease, such as treatment with baclofen as well as physiotherapy … -
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National expert: Monika Oracz, The Office for Registration of Medicinal Products, Medical Devices and Biocides
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 23.27 KB | PDF
active pharmaceutical ingredient Baclofen September 2020- Post-graduate … -
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National expert: Jogin Thakore, European Medicines Agency
- Declaration of interests - 83 KB | PDF
- Curriculum Vitae - 30.16 KB | PDF
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Orphan designation: Riluzole for: Treatment of traumatic spinal cord injury
Date of designation: 16/12/2014, Positive, Last updated: 27/02/2015treatment of spasticity (baclofen, dantrolene, diazepam and … treatment of spasticity (baclofen, dantrolene, diazepam and … -
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National expert: Svenja Esther Sander, Federal Office of Consumer Protection and Food Safety
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 18.86 KB | PDF
pronounced antidystonic effects of baclofen after striatal injections … -
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Orphan designation: Human culture expanded autologous mesenchymal stromal cells for: Treatment of amyotrophic lateral sclerosis (updated)
Date of designation: 24/04/2019, Positive, Last updated: 03/05/2022authorised in the EU to treat ALS. Baclofen was authorised for treating … -
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Human medicine European public assessment report (EPAR): Fampyra (updated)
Fampridine, Multiple Sclerosis
Date of authorisation: 20/07/2011, Revision: 16, Authorised, Last updated: 05/05/2022 -
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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): Fampridine Accord (updated)
Fampridine, Multiple Sclerosis
Date of authorisation: 24/09/2020,
, Revision: 1, Authorised, Last updated: 10/05/2022
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Human medicine European public assessment report (EPAR): MicardisPlus
telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 19/04/2002, Revision: 31, Authorised, Last updated: 25/02/2022 -
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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): 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): Prialt
ziconotide, Injections, Spinal; Pain
Date of authorisation: 21/02/2005, Revision: 27, Authorised, Last updated: 21/12/2021 -
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Human medicine European public assessment report (EPAR): Tolucombi
telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 13/03/2013,, Revision: 10, Authorised, Last updated: 25/02/2022
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Human medicine European public assessment report (EPAR): Micardis
telmisartan, Hypertension
Date of authorisation: 16/12/1998, Revision: 26, Authorised, Last updated: 25/02/2022 -
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Human medicine European public assessment report (EPAR): Memantine ratiopharm
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 12/06/2013,, Revision: 7, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Tolura
telmisartan, Hypertension
Date of authorisation: 04/06/2010,, Revision: 10, Authorised, Last updated: 13/01/2022
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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): Kinzalkomb
telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 19/04/2002, Revision: 38, Authorised, Last updated: 08/12/2021 -
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Human medicine European public assessment report (EPAR): PritorPlus
telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 22/04/2002, Revision: 36, Authorised, Last updated: 08/12/2021 -
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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