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Human medicine European public assessment report (EPAR): Abiraterone Accord
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021,
, Revision: 1, Authorised, Last updated: 25/09/2023
Abiraterone Accord Cancer Neoplasms Genital … Abiraterone Accord … EMA/163793/2021 EMEA/H/C/005408 Abiraterone Accord abiraterone acetate) An overview of Abiraterone Accord and why it is authorised … -
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Human medicine European public assessment report (EPAR): Abiraterone Mylan
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 4, Authorised, Last updated: 11/09/2023
Abiraterone Mylan Cancer Neoplasms Genital … Authorised abiraterone acetate Overview Abiraterone Mylan is a cancer medicine … of the body (metastatic). Abiraterone Mylan is used together with … -
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Human medicine European public assessment report (EPAR): Abiraterone Krka
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 2, Authorised, Last updated: 08/03/2023
Abiraterone Krka Genital Neoplasms … Authorised abiraterone acetate Overview Abiraterone Krka is a cancer medicine … of the body (metastatic). Abiraterone Krka is used together with … -
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 26, Authorised, Last updated: 06/12/2022
abiraterone … Zytiga, INN-abiraterone acetate 30 Churchill … for the public Zytiga abiraterone acetate This is a summary … -
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Withdrawn application: Abilify
aripiprazole, date of withdrawal: 17/11/2009, Post-authorisation, Last updated: 19/11/2009Abilify: Withdrawn application … marketing authorisation for Abilify (aripiprazole) On 17 … for a new indication for Abilify, in the treatment of resistant … -
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Withdrawn application: Abilify MyCite
aripiprazole, date of withdrawal: 17/07/2020, Initial authorisation, Last updated: 22/10/2020Abilify MyCite: Withdrawn application … Abilify MyCite Abilify MyCite aripiprazole aripipr … -
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Human medicine European public assessment report (EPAR): Akeega
abiraterone acetate, Niraparib tosilate monohydrate, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 19/04/2023, Authorised, Last updated: 02/06/2023niraparib / abiraterone acetate … EMEA/H/C/005932 Akeega (niraparib / abiraterone acetate) An overview of … substances: niraparib and abiraterone acetate. How is Akeega … -
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Opinion/decision on a Paediatric investigation plan (PIP): Abilify, aripiprazole
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-000235-PIP02-10-M02, Route(s) of administration: Oral use, Intramuscular use, Pharmaceutical form(s): Tablet, Orodispersible tablet, Oral solution, Solution for injection
Decision date: 26/10/2012, Last updated: 26/11/2012, Compliance check: V, 24/06/2016Invented name Abilify Active substance aripiprazole … investigation plan for aripiprazole (Abilify), (EMEA-000235-PIP02-10-M02 … investigation plan for aripiprazole (Abilify), (EMEA-000235-PIP02-10-M02 … -
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Human medicine European public assessment report (EPAR): Abilify Maintena
aripiprazole, Schizophrenia
Date of authorisation: 14/11/2013, Revision: 20, Authorised, Last updated: 20/07/2023Abilify Maintena Mental Disorders Schizophrenia … orised aripiprazole Overview Abilify Maintena is an antipsychotic … delusions (false beliefs). How is Abilify Maintena used Abilify Maintena is available as … -
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Human medicine European public assessment report (EPAR): Abilify
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 04/06/2004, Revision: 49, Authorised, Last updated: 08/04/2022Abilify Schizophrenia Spectrum and … Abilify … Abilify; INN-aripiprazole 30 … -
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Withdrawn application: Rayoqta
date of withdrawal: 17/07/2020, Initial authorisation, Last updated: 21/10/2020medicine. active substance abicipar pegol and was to be available … active substance in Rayoqta, abicipar pegol, attaches to VEGF-A … Rayoqta Rayoqta abicipar pegol … -
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Opinion/decision on a Paediatric investigation plan (PIP): Niraparib (tosilate monohydrate), abiraterone acetate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002789-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/07/2021, Last updated: 21/06/2021, Compliance check: XNiraparib (tosilate monohydrate) abiraterone acetate OncologyP/0244/2020EMEA-002789-PIP01-20 … tosylate monohydrate) / abiraterone (acetate) (EMEA-002789-PIP01-20 … tosylate monohydrate) / abiraterone (acetate) (EMEA-002789-PIP01-20 … -
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Abiraterone acetate product-specific bioequivalence guidance
Last updated: 23/11/2020Abiraterone acetate product-specific … conditions. bioequivalence of abiraterone acetate … Products for Human Use (CHMP) Abiraterone acetate tablets 250 mg and …
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Press release: Otsuka Pharmaceutical Europe Ltd withdraws its application for an extension of indication for Abilify (aripiprazole)
Last updated: 19/11/2009extension of indication for Abilify (aripiprazole … centrally authorised medicine Abilify (aripiprazole) tablets, orodispersible … tablets and oral solution. Abilify was expected to be used in … -
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Press release: CMDh endorses new advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem
CMDh, Last updated: 25/04/2014next-morning impaired driving ability and mental alertness with … mental alertness and impaired ability to drive and use machinery … next- morning impaired driving ability and mental alertness with … -
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Press release: PRAC recommends product information of zolpidem be updated with new advice to minimise the risk of next-morning impaired driving ability and mental alertness
PRAC, Last updated: 07/03/2014next-morning impaired driving ability and mental alertness … next-morning impaired driving ability and mental alertness (including … next- morning impaired driving ability and mental alertness The … -
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 9, Authorised, Last updated: 01/09/2022
while the reference medicine, Abilify, is available as 5, 10, 15 … to the reference medicine, Abilify. Two medicines are bioequivalent … and to be bioequivalent to Abilify. Therefore, the CHMP’s view … -
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 9, Authorised, Last updated: 26/08/2022
European Union (EU) called Abilify. How is Aripiprazole Zentiva … to the reference medicine, Abilify. Two medicines are bioequivalent … and to be bioequivalent to Abilify. Therefore, the CHMP’s view … -
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 15, Authorised, Last updated: 13/07/2022
European Union (EU) called Abilify. How is Aripiprazole Accord … to the reference medicine, Abilify. Two medicines are bioequivalent … and to be bioequivalent to Abilify. Therefore, the CHMP’s view … -
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 16, Authorised, Last updated: 08/09/2023
European Union (EU) called Abilify. How is Aripiprazole Mylan … to the reference medicine, Abilify. Two medicines are bioequivalent … and to be bioequivalent to Abilify. Therefore, the Committee … -
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Human medicine European public assessment report (EPAR): Rivastigmine Sandoz
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 10/12/2009, Revision: 14, Authorised, Last updated: 25/09/2023affects memory, intellectual ability and behaviour. Rivastigmine … main areas: cognitive (the ability to think, learn and remember … symptoms, behaviour and the ability to carry out everyday activities … -
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Human medicine European public assessment report (EPAR): Fampyra
Fampridine, Multiple Sclerosis
Date of authorisation: 20/07/2011, Revision: 16, Authorised, Last updated: 05/05/2022medicine used to improve walking ability in adults with multiple sclerosis … if a patient’s walking ability worsens or if the patient … measured improvements in walking ability over 24 weeks using a rating … -
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Human medicine European public assessment report (EPAR): Exelon
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/05/1998, Revision: 46, Authorised, Last updated: 08/06/2023affects memory, intellectual ability and behaviour. The capsules … main areas: cognitive (the ability to think, learn and remember … symptoms, behaviour and the ability to carry out everyday activities … -
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Human medicine European public assessment report (EPAR): Oxbryta
Voxelotor, Anemia; Anemia, Hemolytic; Anemia, Sickle Cell
Date of authorisation: 14/02/2022,
, 
, Revision: 4, Authorised, Last updated: 06/07/2023
voxelotor, works by improving the ability of the haemoglobin to hold … action may also reduce the ability of haemoglobin to release … voxelotor, works by improving the ability of the haemoglobin to hold … -
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Human medicine European public assessment report (EPAR): Pombiliti
Cipaglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 20/03/2023,, Authorised, Last updated: 30/05/2023
miglustat improved the physical abilities of patients with late-onset … stabilising the physical abilities of patients with late-onset … miglustat improved the physical abilities of patients with late-onset …