56 results
Keyword finasteride Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Finasteride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: EMEA-001878-PIP01-15, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous spray, Solution
Decision date: 15/04/2016, Last updated: 02/06/2016, Compliance check: XKey facts Finasteride DermatologyP/0113/2016EMEA-001878-PIP01-15 … product specific waiver for finasteride (EMEA-001878-PIP01-15) PDF … product specific waiver for finasteride (EMEA-001878-PIP01-15) in … -
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National expert: Ana Catarina Reis, National Authority Of Medicines And Health Products (updated)
- Declaration of interests - 80.06 KB | PDF
- Curriculum Vitae - 39.82 KB | PDF
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Herbal medicinal product: Sabalis serrulatae fructus
Serenoa repens (W.Bartram) Small (syn. Sabal serrulata (Michx.) Schult.f.), Saw Palmetto Fruit, F: Assessment finalised, Last updated: 16/09/2021that it is as effective as finasteride and tamsulosin (other medicines … that it is as effective as finasteride and tamsulosin (other medicines … -
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Human medicine European public assessment report (EPAR): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,
, Revision: 14, Authorised, Last updated: 30/06/2022
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Human medicine European public assessment report (EPAR): Tadalafil Lilly
tadalafil, Erectile Dysfunction
Date of authorisation: 22/03/2017, Revision: 5, Authorised, Last updated: 17/11/2021 -
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Human medicine European public assessment report (EPAR): Cialis
tadalafil, Erectile Dysfunction
Date of authorisation: 12/11/2002, Revision: 30, Authorised, Last updated: 11/10/2021 -
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Human medicine European public assessment report (EPAR): Olumiant
baricitinib, Arthritis, Rheumatoid
Date of authorisation: 13/02/2017,
, Revision: 10, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Firmagon
degarelix, Prostatic Neoplasms
Date of authorisation: 17/02/2009, Revision: 19, Authorised, Last updated: 04/10/2022 -
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Human medicine European public assessment report (EPAR): Targretin
bexarotene, Lymphoma, T-Cell, Cutaneous
Date of authorisation: 29/03/2001, Revision: 23, Authorised, Last updated: 26/01/2022 -
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Human medicine European public assessment report (EPAR): Silodyx
silodosin, Prostatic Hyperplasia
Date of authorisation: 29/01/2010, Revision: 16, Authorised, Last updated: 10/10/2022 -
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Human medicine European public assessment report (EPAR): Xtandi
enzalutamide, Prostatic Neoplasms
Date of authorisation: 21/06/2013,
Date of refusal: 26/04/2013, Revision: 21, Authorised, Last updated: 17/06/2022 -
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Human medicine European public assessment report (EPAR): Urorec
silodosin, Prostatic Hyperplasia
Date of authorisation: 29/01/2010, Revision: 18, Authorised, Last updated: 06/04/2022 -
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna)
CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), COVID-19 virus infection
Date of authorisation: 06/01/2021,, 
, Revision: 35, Authorised, Last updated: 21/02/2023
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Human medicine European public assessment report (EPAR): Provenge
autologous peripheral-blood mononuclear cells including a minimum of 50 million autologous CD54+ cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor, Prostatic Neoplasms
Date of authorisation: 06/09/2013,, Revision: 1, Withdrawn, Last updated: 19/05/2015
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Referral: Janus kinase inhibitors (JAKi) (updated)
tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, associated names: Xeljanz, Cibinqo, Olumiant, Rinvoq, Jyseleca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/01/2023, EC decision date: 10/03/2023, Last updated: 22/03/2023 -
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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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Paediatric Committee (PDCO): 21-24 February 2023
Virtual meeting, from 21/02/2023 to 24/02/2023, Last updated: 22/02/2023 -
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Paediatric Committee (PDCO): 6-9 September 2022
Virtual meeting, from 06/09/2022 to 09/09/2022, Last updated: 26/10/2022 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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PRAC recommendations on safety signals (updated)
Last updated: 06/03/2023 -
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PDCO: Agendas, minutes and reports
Last updated: 21/02/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/03/2023 -
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Development of the Clinical Trials Information System (updated)
Last updated: 27/02/2023 -
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Class waivers
Last updated: 28/05/2018 -
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Eleventh industry stakeholder platform on the operation of pharmacovigilance in the European Union
European Medicines Agency, London, UK, 02/06/2017, Last updated: 06/06/2017