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Human medicine European public assessment report (EPAR): Feraccru
ferric maltol, Anemia, Iron-Deficiency
Date of authorisation: 18/02/2016, Revision: 17, Authorised, Last updated: 12/12/2022Feraccru Hemic and Lymphatic Diseases Hematologic … Authorised ferric maltol Overview Feraccru is an iron-containing medicine … lack of iron) in adults. Feraccru contains the The substance … -
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Opinion/decision on a Paediatric investigation plan (PIP): Feraccru, ferric maltol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001195-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Oral suspension
Decision date: 11/08/2021, Last updated: 31/08/2022, Compliance check: XInvented name Feraccru Active substance ferric maltol Therapeutic area Haematology-Hemostaseology … paediatric investigation plan for ferric maltol Feraccru), (EMEA-001195-PIP01-11-M05 … paediatric investigation plan for ferric maltol Feraccru), (EMEA-001195-PIP01-11-M05 … -
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Human medicine European public assessment report (EPAR): Rienso
Ferumoxytol, Anemia; Kidney Failure, Chronic
Date of authorisation: 15/06/2012,
, Revision: 7, Withdrawn, Last updated: 13/07/2015
Withdrawn ferumoxytol Overview The marketing authorisation … Public statement on Rienso (ferumoxytol): Withdrawal of the marketing … authorisation for Rienso (ferumoxytol) in the European Union (EU … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rienso, Ferumoxytol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000373-PIP02-09-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 01/04/2015, Last updated: 06/05/2015, Compliance check: XKey facts Rienso Ferumoxytol Haematology-HemostaseologyP/0060/2015EMEA-000373-PIP02-09-M04 … paediatric investigation plan for ferumoxytol, (Rienso) (EMEA-000373-PIP02-09-M04 … investigation plan Related documents Ferumoxytol - Notification of discontinuation … -
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Withdrawn application: Rienso
ferumoxytol, date of withdrawal: 19/01/2015, Post-authorisation, Last updated: 27/02/2015authorisation for Rienso (ferumoxytol) On 19 January 2015 … contains the active substance ferumoxytol. What was Rienso expected … active substance in Rienso, ferumoxytol, is an iron-containing compound … -
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Human medicine European public assessment report (EPAR): Fexeric
ferric citrate coordination complex, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 23/09/2015,, Revision: 2, Withdrawn, Last updated: 04/02/2020
Withdrawn ferric citrate coordination complex … Fexeric ferric citrate coordination complex … citrate coordination complex ferric citrate coordination complex … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fexeric, ferric citrate coordination complex
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001213-PIP02-12-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
Decision date: 15/06/2016, Last updated: 07/03/2019, Compliance check: XKey facts Fexeric ferric citrate coordination complex … paediatric investigation plan for ferric citrate (coordination complex … paediatric investigation plan for ferric citrate (coordination complex … -
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Referral: Intravenous iron-containing medicinal products
ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside, iron sucrose, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 13/09/2013, Last updated: 28/07/2021involved in this procedure were ferric carboxymaltose, iron dextran … carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside … involved in this procedure were ferric carboxymaltose, iron dextran … -
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Human medicine European public assessment report (EPAR): Ferriprox (updated)
Deferiprone, beta-Thalassemia; Iron Overload
Date of authorisation: 25/08/1999, Revision: 32, Authorised, Last updated: 27/02/2023Ferriprox Hemic and Lymphatic Diseases Hematologic … Ferriprox … Ferriprox, INN-Deferiprone 1/1 … -
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Human medicine European public assessment report (EPAR): Fertavid
follitropin beta, Infertility; Hypogonadism
Date of authorisation: 19/03/2009, Revision: 12, Withdrawn, Last updated: 23/06/2020Fertavid Infertility Hypogonadism … Fertavid … Fertavid follitropin beta follitropin … -
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Herbal medicinal product: Camelliae sinensis non fermentatum folium
Camellia sinensis (L.) Kuntze, Green tea, F: Assessment finalised, Last updated: 26/09/2022Camelliae sinensis non fermentatum folium Fatigue and weakness … facts Camelliae sinensis non fermentatum foliumGreen teaCamellia sinensis … sinensis (L.) Kuntze, non fermentatum folium EMA/HMPC/30571/2022Adopted … -
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National expert: Mª Angeles Fernández Fernández, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 16.62 KB | PDF
Mª Angeles Fernández Fernández … Mª Angeles Fernández Fernández … Vitae PERSONAL INFORMATION Mª Angeles Fernandez Fernandez WORK EXPERIENCE May 1999 … -
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National expert: Cristina Fernandez, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 17.09 KB | PDF
Cristina Fernandez … Cristina Fernandez … Vitae PERSONAL INFORMATION Cristina Fernandez WORK EXPERIENCE September … -
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National expert: Carmen Ferrajolo, Italian Medicines Agency (updated)
- Declaration of interests - 80.39 KB | PDF
- Curriculum Vitae - 31.34 KB | PDF
Carmen Ferrajolo … Carmen Ferrajolo … Vitae PERSONAL INFORMATION Carmen Ferrajolo WORK EXPERIENCE March 2022 … -
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National expert: Jason Fernandes, European Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 19.85 KB | PDF
Jason Fernandes … Jason Fernandes … Vitae PERSONAL INFORMATION Jason Fernandes WORK EXPERIENCE December … -
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National expert: Marte Fergestad, Norwegian Medicines Agency (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 17.76 KB | PDF
Marte Fergestad … Marte Fergestad … Vitae PERSONAL INFORMATION Marte Fergestad WORK EXPERIENCE February … -
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National expert: Mylene Ferrier, Ministry Of Health (updated)
- Declaration of interests - 80.3 KB | PDF
- Curriculum Vitae - 16.89 KB | PDF
Mylene Ferrier … Mylene Ferrier … Vitae PERSONAL INFORMATION Mylene Ferrier WORK EXPERIENCE September … -
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National expert: Blaz Ferjanc, Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia (updated)
- Declaration of interests - 80.63 KB | PDF
- Curriculum Vitae - 17.05 KB | PDF
Blaz Ferjanc … Blaz Ferjanc … Vitae PERSONAL INFORMATION Blaz Ferjanc WORK EXPERIENCE July 2016-July … -
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National expert: Augusto Fernandez, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 16.37 KB | PDF
Augusto Fernandez … Augusto Fernandez … Vitae PERSONAL INFORMATION Augusto Fernandez WORK EXPERIENCE February … -
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National expert: Fernando Blanco, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 79.97 KB | PDF
- Curriculum Vitae - 19 KB | PDF
Fernando Blanco … Fernando Blanco … Vitae PERSONAL INFORMATION Fernando Blanco WORK EXPERIENCE October … -
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National expert: Ferran Torres, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 81.81 KB | PDF
- Curriculum Vitae - 48.67 KB | PDF
Ferran Torres … Ferran Torres … Vitae PERSONAL INFORMATION Ferran Torres WORK EXPERIENCE October … -
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National expert: Fernando Cabanas, European Medicines Agency (updated)
- Declaration of interests - 81.66 KB | PDF
- Curriculum Vitae - 39.79 KB | PDF
Fernando Cabanas … Fernando Cabanas … Vitae PERSONAL INFORMATION Fernando Cabanas WORK EXPERIENCE August … -
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National expert: Fernanda Cardoso, National Authority Of Medicines And Health Products (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 16.61 KB | PDF
Fernanda Cardoso … Fernanda Cardoso … Vitae PERSONAL INFORMATION Fernanda Cardoso WORK EXPERIENCE May … -
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National expert: Ferenc Lukacs, National Institute of Pharmacy and Nutrition (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 18.09 KB | PDF
Ferenc Lukacs … Ferenc Lukacs … Vitae PERSONAL INFORMATION Ferenc Lukacs WORK EXPERIENCE August … -
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Opinion/decision on a Paediatric investigation plan (PIP): levonorgestrel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Levonorgestrel, Route(s) of administration: Intrauterine use, Pharmaceutical form(s): Intrauterine delivery system
Decision date: 05/05/2010, Last updated: 22/07/2010, Compliance check: X