Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine Janssen (Ad26.COV2-S [recombinant]) adopted at PRAC meeting 3-6 May 2021
COVID-19 vaccine safety update for COVID-19 Vaccine Janssen: 11 May 2021
Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine Janssen (Ad26.COV2-S [recombinant]) adopted at PRAC meeting 20 April 2021
Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products
Member states contact points for review of national versions of the content of mobile scanning and other technologies
Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages
Veterinary pre-submission meeting request form - in accordance with Regulation (EU) No 2019/6
Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the list of substances essential for the treatment of equine species and for which the withdrawal period for equine species shall be six months
Clinical Trial Information System (CTIS) - Sponsor handbook
Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan Africa