105 results
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Withdrawn application: Abilify
aripiprazole, date of withdrawal: 17/11/2009, Post-authorisation, Last updated: 19/11/2009Abilify: Withdrawn application … marketing authorisation for Abilify (aripiprazole) On 17 … for a new indication for Abilify, in the treatment of resistant … -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Withdrawn application: Abilify MyCite
aripiprazole, date of withdrawal: 17/07/2020, Initial authorisation, Last updated: 22/10/2020Abilify MyCite: Withdrawn application … Abilify MyCite Abilify MyCite aripiprazole aripipr … -
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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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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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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 … -
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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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012
CHMP, Last updated: 14/12/2012Abilify INN aripiprazole Marketing-authorisation … -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 07/05/2015, Initial authorisation, Last updated: 20/07/2015European Union (EU) called Abilify. What was Aripiprazole Mylan … to the reference medicine, Abilify. Two medicines are bioequivalent … European Union (EU) called Abilify. For more information on … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected)
CHMP, Last updated: 21/09/2016Name of medicine Abilify INN aripiprazole More information … application to extend use of Abilify in schizophrenia to 13 and … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013
CHMP, Last updated: 20/09/2013Abilify Maintena … -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 July 2006
CHMP, Last updated: 28/07/2006Abilify … in the European Union: Abilify (aripiprazole), from Otsuka … route of administration, Abilify 7.5 mg/ml solution for injection … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,21-24 April 2008
CHMP, Last updated: 29/04/2008previously approved medicines: Abilify (aripiprazole), from Otsuka … extend the indication for Abilify 7.5 mg/ml solution for injection … therapy is not appropriate. Abilify 7.5 mg/ml solution for injection … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
CHMP, Last updated: 24/07/2020Abilify MyCite … -
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National expert: Inge van Geijlswijk, Medicines Evaluation Board (updated)
- Declaration of interests - 79.99 KB | PDF
- Curriculum Vitae - 25.02 KB | PDF
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,18-21 February 2008
CHMP, Last updated: 21/02/2008Abilify … -
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Human medicine European public assessment report (EPAR): Adasuve
loxapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/02/2013, Revision: 14, Authorised, Last updated: 14/11/2022 -
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Human medicine European public assessment report (EPAR): Kyprolis
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,
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, Revision: 20, Authorised, Last updated: 15/06/2022
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Human medicine European public assessment report (EPAR): Fanaptum
iloperidone, Schizophrenia
Date of refusal: 15/01/2018, Refused, Last updated: 19/03/2018 -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 08/01/2016, Initial authorisation, Last updated: 29/03/2016European Union (EU) called Abilify. What was Aripiprazole … of the reference medicine, Abilify. Two medicines are bioequivalent … -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of designation: 22/05/2006, Expired, Last updated: 25/11/2021 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of designation: 27/07/2005, Positive, Last updated: 14/06/2021