Patient safety, news and press releases from EMA
- Wed, 02 Dec 2020 11:00:00 +0000: EMA website briefly unavailable on 3 December 2020, , 02/12/2020 - News and press releases
The European Medicines Agency's (EMA) corporate website (www.ema.europa.eu) will be briefly unavailable between 22:00 and 23:00 (Central European Time,...
- Tue, 01 Dec 2020 13:00:00 +0000: EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S , , 01/12/2020 - News and press releases
EMA’s human medicines committee (CHMP) has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag International N.V.The CHMP’s...
- Tue, 01 Dec 2020 10:55:00 +0000: EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine, , 01/12/2020 - News and press releases
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 mRNA vaccine by Moderna Biotech Spain, S.L. The assessment...
- Tue, 01 Dec 2020 10:55:00 +0000: EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2 , , 01/12/2020 - News and press releases
EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer. The...
- Fri, 27 Nov 2020 15:00:00 +0000: Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up, , 27/11/2020 - News and press releases
EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities (ICMRA) that urges all stakeholders, including vaccines...
MedWatch Safety Alert RSS Feed
- Wed, 02 Dec 2020 05:00:00 +0000: MPM Medical LLC Issues Voluntary Nationwide Recall of Regenecare HA Hydrogel Due to Burkholderia cepecia Contamination - MedWatch Safety Alerts RSS Feed
Mesquite, TX MPM Medical is voluntarily recalling one lot of Regenecare HA Hydrogel to the consumer level. Following two customer complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepecia.
- Tue, 01 Dec 2020 14:00:00 +0000: 2020 Medical Device Recalls - MedWatch Safety Alerts RSS Feed
List of Medical Device recalls in 2020.
- Tue, 01 Dec 2020 05:00:00 +0000: Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues - MedWatch Safety Alerts RSS Feed
Baxter Sigma Spectrum Infusion Pumps w/ Master Drug Library (V. 6 & 8) and Spectrum IQ Infusion Systems with DoseIQ Safety Software deliver fluids into the body
- Tue, 01 Dec 2020 05:00:00 +0000: WishGarden Herbs Issues Voluntary National Recall of 46 Units of Happy Ducts Compress Due to Bacterial Contamination - MedWatch Safety Alerts RSS Feed
WishGarden Herbs, Inc. is voluntarily recalling one lot of Happy Ducts Compress to the consumer level. After becoming aware of a possible supply chain contamination, a retained product was found to contain the Cronobacter sakazakii bacteria. WishGarden has initiated this recall due to the possible
- Mon, 23 Nov 2020 05:00:00 +0000: Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements - MedWatch Safety Alerts RSS Feed
Fusion Health and Vitality LLC is voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost Labeling was found to contain statements that