87 results
Keyword JCOVDEN Remove keyword
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): Jcovden (previously COVID-19 Vaccine Janssen), COVID-19 vaccine (Ad26.COV2-S (recombinant))
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-002880-PIP01-20, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in cartridge
Decision date: 05/02/2021, Last updated: 16/02/2021, Compliance check: XInvented name Jcovden (previously COVID-19 Vaccine … Jcovden (previously COVID-19 Vaccine … COVID-19 Vaccine Janssen) Jcovden (previously COVID-19 Vaccine … -
List item
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: 30, Authorised, Last updated: 04/07/2023
Jcovden (previously COVID-19 Vaccine … Jcovden (previously COVID-19 Vaccine … Jcovden (previously COVID-19 Vaccine … -
List item
Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: Risk for immune thrombocytopenia (ITP) and venous thromboembolism (VTE)
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 13/10/202113/10/2021 13/10/2021 Key facts Jcovden (previously COVID-19 Vaccine … 13/10/2021 Related content Jcovden (previously COVID-19 Vaccine … Jcovden (previously COVID-19 Vaccine … -
List item
Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 26/04/2021Medicine name Jcovden (previously COVID-19 Vaccine … Jcovden (previously COVID-19 Vaccine … COVID-19 Vaccine Janssen) Jcovden (previously COVID-19 Vaccine … -
List item
Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: Contraindication in individuals with previous capillary leak syndrome and update on thrombosis with thrombocytopenia syndrome
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 19/07/2021syndrome 19/07/2021 Key facts Jcovden (previously COVID-19 Vaccine … 19/07/2021 Related content Jcovden (previously COVID-19 Vaccine … Jcovden (previously COVID-19 Vaccine … -
List item
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
vector vaccine (Vaxzevria or Jcovden). Can children be vaccinated … vector vaccine (Vaxzevria or Jcovden). Can children be vaccinated … -
List item
Safety of COVID-19 vaccines
Last updated: 14/08/2023with the COVID-19 vaccines Jcovden (previously COVID-19 Vaccine …
-
List item
Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 11 March 2021
Online, 11/03/2021, Last updated: 02/03/2021context of the evaluation of Jcovden (previously COVID-19 Vaccine … concerning human medicines. Jcovden (previously COVID-19 Vaccine … -
List item
Press briefing on PRAC conclusions on signal of thromboembolic events with COVID-19 Vaccine Janssen
Virtual meeting, 20/04/2021, Last updated: 16/04/2021management'. safety signal with Jcovden (previously COVID-19 Vaccine … -
List item
Extraordinary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC): 20 April 2021
Virtual meeting, 20/04/2021, Last updated: 20/04/2021management'. safety signal with Jcovden (previously COVID-19 Vaccine … -
List item
News: COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect
PRAC, Last updated: 22/07/2021very rare side effect of Jcovden (previously COVID-19 Vaccine … cases reported in the EEA. Jcovden (previously COVID-19 Vaccine … -
List item
News: EMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary leak syndrome
PRAC, Last updated: 09/07/2021not be vaccinated with Jcovden (previously COVID-19 Vaccine … CHMP)'. CHMP , for endorsement. Jcovden (previously COVID-19 Vaccine … -
List item
News: EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine
CHMP, Last updated: 11/11/2022vector vaccine (Vaxzevria or Jcovden). The Committee for Medicinal … -
List item
News: EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU
CHMP, Last updated: 11/03/2021and vaccines for COVID-19. Jcovden (previously COVID-19 Vaccine … COVID-19 Vaccine Janssen): EPAR Jcovden (previously COVID-19 Vaccine … -
List item
Human medicine European public assessment report (EPAR): COVID-19 Vaccine (inactivated, adjuvanted) Valneva (updated)
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: 27/09/2023
-
List item
Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,, Revision: 30, Authorised, Last updated: 21/09/2023
-
List item
Human medicine European public assessment report (EPAR): Nuvaxovid
SARS-CoV-2 recombinant spike protein, COVID-19 virus infection
Date of authorisation: 20/12/2021,, Revision: 10, Authorised, Last updated: 24/08/2023
-
List item
Human medicine European public assessment report (EPAR): Spikevax (previously COVID-19 Vaccine Moderna) (updated)
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: 40, Authorised, Last updated: 28/09/2023
-
List item
Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA 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: 21/12/2020,, , Revision: 44, Authorised, Last updated: 28/09/2023
-
List item
COVID-19: latest updates (archive)
Last updated: 05/06/2023marketing authorisation for Jcovden to standard The approval to … States. marketing authorisation Jcovden (previously COVID-19 Vaccine …
-
List item
News: COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
PRAC, Last updated: 14/04/2021protect people’s health. Jcovden (previously COVID-19 Vaccine … -
List item
News: EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
Last updated: 07/06/2021https://www.isth.org/page/covid19 Jcovden (previously COVID-19 Vaccine … -
List item
Human medicine European public assessment report (EPAR): Bimervax (updated)
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains, COVID-19 virus infection
Date of authorisation: 30/03/2023,, Revision: 2, Authorised, Last updated: 01/09/2023
-
List item
Human medicine European public assessment report (EPAR): Ronapreve
casirivimab, imdevimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 5, Authorised, Last updated: 10/07/2023
-
List item
News: COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis
PRAC, Last updated: 11/06/2021