181 results
Keyword RoActemra Remove keyword
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CHMP: Agendas, minutes and highlights (updated)
Last updated: 31/05/2023 -
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Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
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,
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, Revision: 37, Authorised, Last updated: 31/05/2023
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Newsletters (updated)
Last updated: 30/05/2023 -
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COVID-19: latest updates (updated)
Last updated: 25/05/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/05/2023 -
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Annual reports and work programmes (updated)
Last updated: 15/05/2023 -
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News: EMA annual report 2022 published (new)
Last updated: 15/05/2023 -
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Committee for Medicinal Products for Human Use (CHMP): 24-26 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 24/04/2023 to 26/04/2023, Last updated: 24/04/2023 -
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Availability of medicines during COVID-19 pandemic
Last updated: 19/04/2023 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023
PRAC, Last updated: 14/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 April 2023
European Medicines Agency, Amsterdam, the Netherlands, from 11/04/2023 to 14/04/2023, Last updated: 11/04/2023 -
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Human medicine European public assessment report (EPAR): RoActemra
tocilizumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection
Date of authorisation: 15/01/2009, Revision: 41, Authorised, Last updated: 04/04/2023RoActemra Musculoskeletal Diseases Joint … horised tocilizumab Overview RoActemra is a medicine used to treat … has not worked well enough. RoActemra is used in combination with … -
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Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva
SARS-CoV-2 virus (inactivated) Wuhan strain hCoV-19 / Italy / INMI1-isl / 2020, COVID-19 virus infection
Date of authorisation: 24/06/2022,, Revision: 6, Authorised, Last updated: 04/04/2023
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 November - 1 December 2022
European Medicines Agency, Amsterdam, the Netherlands, from 28/11/2022 to 01/12/2022, Last updated: 03/04/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 4-7 July 2022
European Medicines Agency, Amsterdam, the Netherlands, from 04/07/2022 to 07/07/2022, Last updated: 31/03/2023 -
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Human medicine European public assessment report (EPAR): Kineret
anakinra, Arthritis, Rheumatoid; COVID-19 virus infection
Date of authorisation: 08/03/2002, Revision: 33, Authorised, Last updated: 29/03/2023 -
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Human medicine European public assessment report (EPAR): Enspryng
satralizumab, Neuromyelitis Optica
Date of authorisation: 24/06/2021,
, Revision: 2, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 50, Authorised, Last updated: 13/03/2023 -
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Human medicine European public assessment report (EPAR): Jcovden (previously COVID-19 Vaccine Janssen)
adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), COVID-19 virus infection
Date of authorisation: 11/03/2021,, , Revision: 28, Authorised, Last updated: 17/02/2023
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Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000309-PIP06-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 29/10/2021, Last updated: 10/02/2023, Compliance check: XInvented name RoActemra Active substance tocilizumab … specific waiver for tocilizumab (RoActemra), (EMEA-000309-PIP06-21 … specific waiver for tocilizumab (RoActemra), (EMEA-000309-PIP06-21 … -
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Withdrawn application: Olumiant
baricitinib, date of withdrawal: 07/12/2022, Post-authorisation, Last updated: 02/02/2023 -
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News: ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2
Last updated: 09/12/2022statement does not refer to RoActemra, another monoclonal antibody … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2022
PRAC, Last updated: 02/12/2022 -
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Human medicine European public assessment report (EPAR): VidPrevtyn Beta
SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain), COVID-19 virus infection
Date of authorisation: 10/11/2022,, Authorised, Last updated: 30/11/2022
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Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2022
European Medicines Agency, Amsterdam, the Netherlands, from 10/10/2022 to 13/10/2022, Last updated: 23/11/2022