106 results
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Opinion/decision on a Paediatric investigation plan (PIP): Latuda, Lurasidone hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-001230-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2019, Last updated: 21/09/2021, Compliance check: V, 11/12/2019AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.p.A … Tel. +3906780531 E-mail: angeliniregulatoryaffairs@angelinipharma.com Decision type PM: decision … -
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Opinion/decision on a Paediatric investigation plan (PIP): benzydamine (hydrochloride), econazole nitrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002143-PIP01-17, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Pessary
Decision date: 30/06/2017, Last updated: 25/07/2017, Compliance check: XAziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A … 0691045249 E-mail: ma.gatto@angelini.it ; m.gatto angelini.it W: decision granting a … Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A … -
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Opinion/decision on a Paediatric investigation plan (PIP): Trazodone (hydrochloride), gabapentin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002263-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XAziende Chimiche Riunite Angelini Francesco - A.C.R.A.F … 0691045249 E-mail: m.gatto@angelini.it W: decision granting … Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F … -
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Opinion/decision on a Paediatric investigation plan (PIP): Trazodone (hydrochloride)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-002142-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form
Decision date: 19/12/2017, Last updated: 05/03/2018, Compliance check: XAziende Chimiche Riunite Angelini Francesco - A.C.R.A.F - S.p.A … 0691045249 E-mail: m.gatto@angelini.it P: decision agreeing on … Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F … -
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Human medicine European public assessment report (EPAR): Ontozry
cenobamate, Epilepsy
Date of authorisation: 26/03/2021,
, Revision: 4, Authorised, Last updated: 08/09/2022
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Human medicine European public assessment report (EPAR): Latuda
lurasidone, Schizophrenia
Date of authorisation: 21/03/2014, Revision: 25, Authorised, Last updated: 17/03/2022 -
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National expert: Nigel Olisa, European Medicines Agency (updated)
- Declaration of interests - 80.28 KB | PDF
- Curriculum Vitae - 16.55 KB | PDF
Ingelheim, Teva, Servier, Angelini, Compass Pathways All supporting … -
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National expert: Emilio Perucca, Italian Medicines Agency (updated)
- Declaration of interests - 85.84 KB | PDF
- Curriculum Vitae - 116.29 KB | PDF
epilepsy 07/2021-(current) Angelini cenobamate epilepsy 01/2021-07/2021 … editorial activities, speaker Angelini Consultant, Advisory Board … -
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National expert: Tiziana Mongini, Italian Medicines Agency (updated)
- Declaration of interests - 81.6 KB | PDF
- Curriculum Vitae - 32.71 KB | PDF
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National expert: Diego Alejandro Dri, Italian Medicines Agency (updated)
- Declaration of interests - 80.88 KB | PDF
- Curriculum Vitae - 22.07 KB | PDF
Type of Interest Declared Angelini Acraf S.p.A. Spouse working … -
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National expert: Georgios Papazisis, National Organization for Medicines (updated)
- Declaration of interests - 80.18 KB | PDF
- Curriculum Vitae - 37.77 KB | PDF
Interest Aziende Chimiche Riunite Angelini Francesco SpA honoraria 2.5 … -
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National expert: Serena Zamponi, Italian Medicines Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 17.71 KB | PDF
development trainee ACRAF S.p.a. - Angelini (Italy) - Pre-formulation … -
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Human medicine European public assessment report (EPAR): Xydalba
dalbavancin hydrochloride, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 19/02/2015, Revision: 15, Authorised, Last updated: 14/12/2022 -
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National expert: Wim Van Paesschen, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 83.39 KB | PDF
- Curriculum Vitae - 83.76 KB | PDF
Indication 06/2022-(current) Angelini Pharma Cenobamate epilepsy … -
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Human medicine European public assessment report (EPAR): Akynzeo
netupitant, palonosetron hydrochloride, Vomiting; Neoplasms; Nausea; Cancer
Date of authorisation: 27/05/2015, Revision: 14, Authorised, Last updated: 09/11/2022 -
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Human medicine European public assessment report (EPAR): Myozyme
alglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 28/03/2006, Revision: 22, Authorised, Last updated: 15/11/2022 -
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National expert: Fiorentino Capozzoli, Italian Medicines Agency (updated)
- Declaration of interests - 80.02 KB | PDF
- Curriculum Vitae - 19.37 KB | PDF
INFORMATION Expertise Publications 1) Angelini R, Capozzoli F, Lepore P … -
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National expert: Alessandra Spagnoli, Italian Medicines Agency (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 32.51 KB | PDF
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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): Peyona (previously Nymusa)
Caffeine citrate, Apnea
Date of authorisation: 02/07/2009, Revision: 13, Authorised, Last updated: 22/12/2021 -
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Human medicine European public assessment report (EPAR): Pravafenix
fenofibrate, Pravastatin, Dyslipidemias
Date of authorisation: 14/04/2011, Revision: 6, Authorised, Last updated: 17/03/2021 -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
CHMP, Last updated: 24/07/2020Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A … -
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National expert: Francesco Onida, Italian Medicines Agency (updated)
- Declaration of interests - 81.89 KB | PDF
- Curriculum Vitae - 50.99 KB | PDF
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National expert: Carla Marcella Caramella, Italian Medicines Agency (updated)
- Declaration of interests - 80.09 KB | PDF
- Curriculum Vitae - 38.05 KB | PDF
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Referral: Synchron
Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/05/2022, EC decision date: 28/11/2022, Last updated: 16/12/2022