24 results
Keyword Fluoxetina Fidia Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Culture expanded autologous chondrocytes
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-000736-PIP01-09, Route(s) of administration: Implant use, Pharmaceutical form(s): Implant
Decision date: 27/01/2012, Last updated: 24/02/2012, Compliance check: Xcartilage disorders Implant use Fidia Advanced Biopolymers S.r.l … Advanced Biopolymers S.r.l. info@fidiapharma.it Italy +39 0498232111 P … application submitted by Fidia Advanced Biopolymers S.r.l … -
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National expert: Carla Marcella Caramella, Italian Medicines Agency (updated)
- Declaration of interests - 39.88 KB | PDF
- Curriculum Vitae - 48.59 KB | PDF
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Human medicine European public assessment report (EPAR): Slenyto
melatonin, Sleep Initiation and Maintenance Disorders; Autistic Disorder
Date of authorisation: 20/09/2018, Revision: 8, Authorised, Last updated: 31/07/2023 -
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Human medicine European public assessment report (EPAR): Circadin
melatonin, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/06/2007, Revision: 34, Authorised, Last updated: 17/05/2023 -
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Administration and Corporate Management
Last updated: 02/03/2023Clinical Research Assistant, Fidia Farmaceutici SpA, Abano Terme …
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Withdrawn application: Hyalograft C autograft
date of withdrawal: 14/01/2013, Initial authorisation, Last updated: 14/05/2013 -
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Referral: Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 19/08/2005, Last updated: 03/11/2005 -
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Referral: Topiramate (updated)
topiramate, Article 31 referrals
Status: Recommendation provided by Pharmacovigilance Risk Assessment Committee, Last updated: 01/09/2023 -
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Referral: Retinoid-containing medicinal products
acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene, associated names: Targretin, Panretin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/03/2018, EC decision date: 21/06/2018, Last updated: 02/07/2018 -
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Referral: Bisphosphonates
alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid, associated names: Actonel, Aredia, Bonefos, Didronel, Fosamax, Nerixia, Skelid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/04/2011, EC decision date: 13/07/2011, Last updated: 28/10/2011 -
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Referral: Zolpidem-containing medicines
zolpidem, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 23/06/2014, Last updated: 04/08/2014 -
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Referral: Diclofenac-containing medicines
diclofenac, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 25/09/2013, Last updated: 27/11/2013 -
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Referral: Cyproterone- and ethinylestradiol-containing medicines
cyproterone, ethinyl estradiol, associated names: Acnemine, Acneson, Chloe, Clairette, Cyprest, Cyprodiol, Diane 35, Dianette, Feminil, Minerva, Zyrona, Article 107i procedures
Status: European Commission final decision, opinion/position date: 29/05/2013, EC decision date: 25/07/2013, Last updated: 05/08/2013 -
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Public data from Article 57 database
Last updated: 30/06/2023 -
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List of medicines under additional monitoring
Last updated: 27/07/2023 -
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Committee for Orphan Medicinal Products (COMP): 13-15 June 2023
European Medicines Agency, Amsterdam, the Netherlands, from 13/06/2023 to 15/06/2023, Last updated: 09/06/2023 -
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First EMEA Workshop on Advanced Therapy Medicinal Products (ATMPs)
London, 03/04/2009, Last updated: 01/04/2009 -
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Paediatric Committee (PDCO): 7-9 December 2011
European Medicines Agency, London, UK, from 07/12/2011 to 09/12/2011, Last updated: 11/06/2010autologous chondrocytes, from Fidia Advanced Biopolymers S.r.l … -
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Outcomes of imposed non-interventional post-authorisation safety studies
Last updated: 27/06/2022 -
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COMP: Agendas, minutes and meeting reports (updated)
Last updated: 19/09/2023 -
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Annual reports and work programmes
Last updated: 28/06/2023 -
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Press release: European Medicines Agency publishes 2012 annual report
Last updated: 16/04/2013 -
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Guidance documents
Last updated: 19/07/2022 -
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PDCO: Committee meeting report archive 2007-2011
Last updated: 16/09/2013autologous chondrocytes, from Fidia Advanced Biopolymers S.r.l …