Pharmaceutical Services



- 09/02/2024 Kick-off meeting of the EU4Health Programme Joint Action IncreaseNET
- 20/09/2023 EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
- 20/09/2023 Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
- 31/08/2023 Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
- 17/02/2023 CHESSMEN, the Joint Action to mitigate medicine’s shortages
- 01/02/2023 Quick Guide on CTR
- 24/11/2022 EMA recommends approval of VidPrevtyn Beta as a COVID-19 booster vaccine
- 02/11/2022 EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
- 02/11/2022 EMA recommends approval of second adapted Spikevax vaccine
- 02/11/2022 EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
- 21/09/2022 EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines
- 13/09/2022 Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval
- 09/09/2022 ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
- 09/09/2022 COVID-19: recommendations on use of adapted vaccines
- 02/09/2022 First adapted COVID-19 booster vaccines recommended for approval in the EU
- 01/09/2022 Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan
- 24/08/2022 EMA’s Emergency Task Force advises on intradermal use of Imvanex/Jynneos against monkeypox
- 24/08/2022 Considerations on posology for the use of the vaccine Jynneos/ Imvanex (MVA-BN) against monkeypox
- 19/08/2022 EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine
- 08/08/2022 COVID-19 vaccines safety update
- 22/07/2022 EMA recommends approval of Imvanex for the prevention of monkeypox disease
- 12/07/2022 Updated joint statement from ECDC and EMA on additional booster doses of COVID-19 vaccines
- 12/07/2022 ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines
- 29/06/2022 Possible use of the vaccine Jynneos against infection by monkeypox virus
- 29/06/2022 EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
- 29/06/2022 EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
- 29/06/2022 Monkeypox: EMA starts review for Imvanex
- 20/06/2022 Start of rolling review for adapted Spikevax COVID-19 vaccine
- 16/06/2022 Start of rolling review for adapted Comirnaty COVID-19 vaccine
- 05/04/2022 EMA starts rolling review of COVID-19 Vaccine HIPRA (PHH-1V)
- 28/03/2022 EMA recommends authorisation of COVID-19 medicine Evusheld
- 28/02/2022 EMA recommends authorisation of booster doses of Comirnaty from 12 years of age
- 28/02/2022 EMA recommends approval of Spikevax for children aged 6 to 11
- 28/02/2022 Hydroxyethyl-starch solutions for infusion recommended for suspension from the market
- 09/02/2022 EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents
- 31/01/2022 COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
- 20/01/2022 COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
- 12/01/2022 Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
- 10/01/2022 EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
- 03/01/2022 CTIS go-live and OMS registration
- 21/12/2021 Nuvaxovid COVID-19 vaccine (recombinant, adjuvanted)
- 20/12/2021 EMA recommends Nuvaxovid for authorisation in the EU
- 17/12/2021 Increase in manufacturing capacity for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer
- 17/12/2021 EMA recommends approval for use of Kineret in adults with COVID-19
- 17/12/2021 EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19
- 17/12/2021 COVID-19: EMA recommends authorisation of antibody medicine Xevudy
- 15/12/2021 EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19
- 14/12/2021 EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19
- 10/12/2021 EMA and ECDC recommendations on heterologous vaccination courses against COVID-19
- 07/12/2021 EMA recommends approval for use of RoActemra in adults with severe COVID-19
- 02/12/2021 Increase in manufacturing capacity for COVID-19 vaccine from AstraZeneca
- 02/12/2021 EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)
- 26/11/2021 Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
- 24/11/2021 EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID-19
- 17/11/2021 EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid
- 12/11/2021 COVID-19: EMA recommends authorisation of two monoclonal antibody medicines
- 11/11/2021 EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
- 11/11/2021 COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir
- 04/11/2021 Questions and answers on end of rolling review for antibodies bamlanivimab and etesevimab for COVID-19
- 04/11/2021 EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
- 01/11/2021 COVID-19: EMA starts rolling review of molnupiravir
- 01/11/2021 Spikevax: EMA recommendation on booster dose
- 19/10/2021 EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
- 15/10/2021 EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
- 13/10/2021 EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG
- 05/10/2021 Comirnaty and Spikevax EMA recommendations on extra doses and boosters
- 28/09/2021 EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
- 06/09/2021 EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty
- 02/09/2021 ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines
- 16/08/2021 EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19
- 05/08/2021 Second ECDC and EMA update on COVID-19
- 26/07/2021 COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU
- 23/07/2021 COVID-19 Vaccine Janssen Guillain-Barré syndrome listed as a very rare side effect
- 09/07/2021 EMA advises against use of COVID-19 Vaccine Janssen in people with history of capillary leak syndrome
- 09/07/2021 Ο EMA συνιστά να μην χρησιμοποιείται το εμβόλιο COVID-19 Janssen σε άτομα με ιστορικό συνδρόμου τριχοειδούς διαρροής
- 09/07/2021 Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis
- 09/07/2021 EMA finds no evidence linking viral vector in Zynteglo to blood cancer
- 09/07/2021 Champix_shortage catalogue
- 11/06/2021 Vaxzevria EMA advises against use in people with history of capillary leak syndrome
- 11/06/2021 COVID-19 vaccines update on ongoing evaluation of myocarditis and pericarditis
- 07/06/2021 EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome
- 31/05/2021 First COVID-19 vaccine approved for children aged 12 to 15 in EU
- 27/05/2021 Insufficient data on use of inhaled corticosteroids to treat COVID-19
- 21/05/2021 Vaxzevria further advice on blood clots and low blood platelets
- 21/05/2021 EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19
- 05/05/2021 EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated
- 05/05/2021 EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen
- 05/05/2021 EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15
- 15/04/2021 AstraZenecas COVID-19 vaccine EMA to provide further context on risk of very rare blood clots with low blood platelets
- 09/04/2021 AstraZenecas COVID-19 vaccine EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
- 26/03/2021 regdanvimab opinion on 5(3)
- 26/03/2021 COVID-19 Vaccine AstraZeneca - Signal of thromboembolic events - Ad hoc expert group meeting 29 March 2021
- 26/03/2021 Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca BioNTech Pfizer and Moderna
- 26/03/2021 COVID-19 Vaccine AstraZeneca - Signal of thromboembolic events - Ad hoc expert group meeting 29 March 2021
- 19/03/2021
- 17/03/2021 Covid-19 Vaccine AstraZeneca thromboembolism - interim statement
- 16/03/2021 COVID-19 vaccine AstraZeneca thromboembolism - further update
- 11/03/2021 Janssen's COVID-19 vaccine_news announcement 2021
- 11/03/2021 Covid-19 Vaccine Janssen medicine overview_SMOP
- 11/03/2021 COVID-19 Vaccine AstraZeneca_PRAC preliminary view suggests no specific issue with batch used in Austria
- 10/03/2021 COVID-19 Vaccine Sputnik V Start of RR communication
- 10/03/2021 Electronic submission CTAs
- 02/03/2021 EMA issues advice on use of REGN-COV2 antibody combination (casirivimab_imdevimab)
- 25/02/2021 EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19
- 24/02/2021 EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental oxygen
- 17/02/2021 Zynteglo suspension- communication
- 17/02/2021 COVID-19 Vaccine Janssen CMA submission
- 12/02/2021 CureVacs COVID-19 vaccine (CVnCoV) - Start of rolling review
- 11/02/2021 News announcement Sputnik
- 05/02/2021 EMA communication on the start of two Art5(3) procedures
- 04/02/2021 COVID-19 Vaccine Novavax - EMA communication on the start of RR
- 02/02/2021 EMA communication on the start of rolling review of REGN-COV2 antibody combination
- 29/01/2021 EMA Communication on Comirnaty PI update_dosage interval
- 29/01/2021 EMA Communication_first COVID-19 vaccine safety update published_2
- 29/01/2021 COVID-19 vaccine safety update for Comirnaty
- 12/01/2021 EMA communication_conditional marketing authorisation application of COVID-19 Vaccine AstraZeneca
- 08/01/2021 EMA communication_Comirnaty extra dose
- 07/01/2021 Moderna medicine overview_SMOP
- 07/01/2021 Press release_Moderna CMA opinion
- 31/12/2020 Press release_Update on rolling review of AstraZenecas COVID-19 vaccine
- 04/12/2020 EMA Press Release - Guidance how to manage clinical trials during COVID-19




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