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Human medicine European public assessment report (EPAR): Abiraterone Accord
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021,
, Authorised, Last updated: 05/05/2021
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 (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 2, Authorised, Last updated: 17/03/2023
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 (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 2, Authorised, Last updated: 08/03/2023
Abiraterone Krka Genital Neoplasms … Abiraterone Krka … EMA/258413/2021 EMEA/H/C/005649 Abiraterone Krka abiraterone acetate) An overview of Abiraterone Krka and why it is authorised … -
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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
Authorised abiraterone Overview This is a summary … medicine. active substance abiraterone acetate. How is Zytiga used … active substance in Zytiga, abiraterone acetate, is changed in the … -
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Withdrawn application: Abilify
aripiprazole, date of withdrawal: 17/11/2009, Post-authorisation, Last updated: 19/11/2009Abilify: Withdrawn application … marketing authorisation for Abilify (aripiprazole) On 17 … for a new indication for Abilify, in the treatment of resistant … -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Withdrawn application: Abilify MyCite
aripiprazole, date of withdrawal: 17/07/2020, Initial authorisation, Last updated: 22/10/2020Abilify MyCite: Withdrawn application … Abilify MyCite Abilify MyCite aripiprazole aripipr … -
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Summary of opinion: Akeega
niraparib, abiraterone acetate, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023niraparib abiraterone acetate Opinion On 23 February … authorisation) Akeega niraparib / abiraterone acetate On 23 February … 50 mg niraparib / 500 mg abiraterone acetate or 100 mg niraparib … -
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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
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 04/06/2004, Revision: 49, Authorised, Last updated: 08/04/2022Abilify Schizophrenia Spectrum and … assessment report (EPAR) for Abilify. It explains how the Agency … practical advice on how to use Abilify. For practical information … -
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Human medicine European public assessment report (EPAR): Abilify Maintena
aripiprazole, Schizophrenia
Date of authorisation: 14/11/2013, Revision: 19, Authorised, Last updated: 14/12/2021Abilify 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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Withdrawn application: Rayoqta
date of withdrawal: 17/07/2020, Initial authorisation, Last updated: 21/10/2020Rayoqta 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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National expert: Wiem ABID, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 79.77 KB | PDF
- Curriculum Vitae - 17.9 KB | PDF
Wiem ABID … Wiem ABID … Vitae PERSONAL INFORMATION Wiem ABID WORK EXPERIENCE November … -
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National expert: Marie Holm Abildgaard, Danish Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 16.45 KB | PDF
Marie Holm Abildgaard … Marie Holm Abildgaard … Vitae PERSONAL INFORMATION Marie Holm Abildgaard WORK EXPERIENCE May 2021 … -
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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 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: 15, Authorised, Last updated: 12/01/2023
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): 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 Committee … -
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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 Committee … -
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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): Jevtana (updated)
cabazitaxel, Prostatic Neoplasms
Date of authorisation: 17/03/2011, Revision: 21, Authorised, Last updated: 17/03/2023Cabazitaxel works by blocking the ability of cancer cells to break … CHMP) considered that the ability of Jevtana to prolong overall … Cabazitaxel works by blocking the ability of cancer cells to break … -
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Human medicine European public assessment report (EPAR): Opdualag
nivolumab, Relatlimab, Melanoma
Date of authorisation: 15/09/2022,
, Authorised, Last updated: 17/10/2022