Withdrawn applications and products

HumanCOVID-19

COVID-19 vaccines withdrawn from marketing authorisation

Vaccine developers have withdrawn the marketing authorisation for the following COVID-19 vaccines:

VaccineVaccine developerKey milestonesMore information
COVID-19 Vaccine (inactivated, adjuvanted) ValnevaValneva Austria GmbHMarketing authorisation issued: 24/06/2022
 
Withdrawal of the marketing authorisation: 12/10/2023
Public statement on COVID-19 Vaccine (inactivated, adjuvanted) Valneva
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)AstraZeneca AB

Conditional marketing authorisation issued: 29/01/2021

Annual renewal issued: 09/11/2021

Standard marketing authorisation issued: 31/10/2022

Withdrawal of the marketing authorisation: 27/03/2024

Public statement on Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
VidPrevtyn BetaSanofi Pasteur

Marketing authorisation issued: 10/11/2022

Withdrawal of the marketing authorisation: 11/03/2024

Public statement on VidPrevtyn Beta
Jcovden (previously COVID-19 Vaccine Janssen)Janssen-Cilag International NV

Conditional marketing authorisation issued: 11/03/2021

Annual renewal issued: 03/01/2022

Standard marketing authorisation issued: 10/01/2023

Withdrawal of the marketing authorisation: 09/08/2024

Public statement on Jcovden (COVID-19 Vaccine Janssen (Ad26.COV2.S)

COVID-19 vaccines withdrawn from rolling review

Vaccine developers have withdrawn the following COVID-19 vaccines from the rolling review process:

VaccineVaccine developerKey milestonesMore information
CVnCoVCureVac AGRolling review started: 12/02/2021
 
Withdrawn from rolling review: 12/10/2021

COVID-19 vaccines withdrawn from marketing authorisation evaluation

Vaccine developers have withdrawn the following COVID-19 vaccines from the marketing authorisation evaluation process:

VaccineVaccine developerKey milestonesMore information
Skycovion SK Chemicals GmbHMarketing authorisation evaluation started: 18/08/2022
 
Withdrawn from marketing authorisation evaluation: 01/09/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023

COVID-19 treatments withdrawn from marketing authorisation evaluation

Treatment developers have withdrawn the following COVID-19 treatments from the marketing authorisation evaluation process:

TreatmentTreatment developerKey milestonesMore information
Olumiant (baricitinib)Eli Lilly Nederland B.V.Marketing authorisation evaluation started: 23/11/2021

Withdrawn from marketing authorisation evaluation: 07/12/2022

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022

 

Lagevrio (molnupiravir)Merck Sharp & Dohme and Ridgeback Biotherapeutics

Marketing authorisation evaluation started: 23/11/2021

CHMP negative opinion: 23/02/2023

Re-examination request submitted: 13/03/2023

Withdrawn from marketing authorisation evaluation: 21/06/2023

 

COVID-19 treatments withdrawn from rolling review

Treatment developers have withdrawn the following COVID-19 treatments from the rolling review process:

TreatmentTreatment developerKey milestonesMore information
Bamlanivimab and etesevimabEli LillyRolling review started: 11/03/2021

Withdrawn from rolling review: 29/10/2021

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