Blog
RSS FeedPosted by Michael Wonder on 11 Jul 2023
EMA statement on on-going review of GLP-1 receptor agonists
11 July 2023 - EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts ...
Posted by Michael Wonder on 05 Jul 2023
Global regulators confirm good safety profile of COVID-19 vaccines
5 July 2023 - EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the ...
Posted by Michael Wonder on 11 Nov 2022
CHMP issues opinion related to review of medicines within the Janus kinase inhibitor class
11 November 2022 - AbbVie announced today the EMA's CHMP has adopted an opinion following a nine month review of the ...
Posted by Michael Wonder on 28 Oct 2022
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
28 October 2022 - EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated ...
Posted by Michael Wonder on 22 Jul 2022
EMA recommends restricting use of cancer medicine Rubraca
22 July 2022 - EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used ...
Posted by Michael Wonder on 14 Feb 2022
EMA starts safety review of Janus kinase inhibitors for inflammatory disorders
11 February 2022 - EMA’s safety committee, PRAC, has started a review of the safety of Janus kinase (JAK) inhibitors ...
Posted by Michael Wonder on 18 Jan 2022
COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...
Posted by Michael Wonder on 11 Jul 2021
EMA advises against use of COVID-19 vaccine Janssen in people with history of capillary leak syndrome
9 July 2021 - EMA’s safety committee has recommended that people who have previously had capillary leak syndrome must not be ...
Posted by Michael Wonder on 09 Jul 2021
Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis
9 July 2021 - EMA’s safety committee (PRAC) has concluded that myocarditis and pericarditis can occur in very rare cases ...
Posted by Michael Wonder on 14 Jun 2021
Vaxzevria: EMA advises against use in people with history of capillary leak syndrome
11 June 2021 - EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not ...
Posted by Michael Wonder on 07 Jun 2021
EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
7 June 2021 - EMA’s COVID-19 taskforce (COVID-ETF) is advising health care professionals in the EU to consider recommendations by learned ...
Posted by Michael Wonder on 21 May 2021
Vaxzevria: further advice on blood clots and low blood platelets
21 May 2021 - EMA has provided additional advice on blood clots or low blood platelets occurring after vaccination with Vaxzevria ...
Posted by Michael Wonder on 26 Apr 2021
EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe
26 April 2021 - The EMA and the European Centre for Disease Prevention and Control today kicked off a new ...
Posted by Michael Wonder on 24 Apr 2021
AstraZeneca’s COVID-19 vaccine: benefits and risks in context
23 April 2021 - Vaxzevria (formerly COVID-19 Vaccine AstraZeneca) is authorised in the EU to prevent COVID-19, which can cause ...
Posted by Michael Wonder on 20 Apr 2021
COVID-19 vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
20 April 2021 - EMA confirms overall benefit-risk remains positive ...