14 results
Keyword Naemis Remove keyword
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News: EMA starts review of meningioma risk with nomegestrol- and chlormadinone-containing medicines
PRAC, Last updated: 01/10/2021Belara, Lutenyl, Luteran, Naemis, Zoely and several A generic … -
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Human medicine European public assessment report (EPAR): Zoely
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011, Revision: 23, Authorised, Last updated: 16/02/2023 -
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News: Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma
PRAC, Last updated: 08/07/2022Belara, Lutenyl, Luteran, Naemis and Zoely and as A generic … -
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News: New measures to minimise risk of meningioma with medicines containing nomegestrol or chlormadinone
CHMP, Last updated: 02/09/2022Belara, Lutenyl, Luteran, Naemis and Zoely and as A generic … -
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Human medicine European public assessment report (EPAR): Blitzima
rituximab, Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell
Date of authorisation: 13/07/2017,
, Revision: 18, Authorised, Last updated: 02/02/2023
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Human medicine European public assessment report (EPAR): Ioa
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 16/11/2011, Revision: 4, Withdrawn, Last updated: 26/08/2014 -
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Human medicine European public assessment report (EPAR): Tygacil
Tigecycline, Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections
Date of authorisation: 24/04/2006, Revision: 34, Authorised, Last updated: 11/10/2022 -
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Human medicine European public assessment report (EPAR): INOmax
Nitric oxide, Hypertension, Pulmonary; Respiratory Insufficiency
Date of authorisation: 01/08/2001, Revision: 22, Authorised, Last updated: 15/01/2021 -
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Human medicine European public assessment report (EPAR): Ritemvia
rituximab, Lymphoma, Non-Hodgkin; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 13/07/2017,
, , Revision: 8, Withdrawn, Last updated: 16/08/2021
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Human medicine European public assessment report (EPAR): Breyanzi
CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells), CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells), Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Mediastinal Neoplasms
Date of authorisation: 04/04/2022,, Authorised, Last updated: 20/05/2022
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Human medicine European public assessment report (EPAR): Heparesc
Human heterologous liver cells, Urea Cycle Disorders, Inborn
Date of refusal: 21/12/2015,
, Refused, Last updated: 04/04/2016
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Referral: Nomegestrol and chlormadinone
nomegestrol, chlormadinone, associated names: Zoely, Article 31 referrals
Status: European Commission final decision, opinion/position date: 01/09/2022, EC decision date: 28/11/2022, Last updated: 14/12/2022 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 27-30 September 2021
PRAC, Last updated: 01/10/2021Belara, Lutenyl, Luteran, Naemis, Zoely and several generic … -
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Public data from Article 57 database
Last updated: 17/10/2022