Patient safety, news and press releases from EMA
- Fri, 18 Sep 2020 10:10:00 +0000: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020, CHMP, 18/09/2020 - News and press releases
Seven new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2020 meeting... - Fri, 18 Sep 2020 10:00:00 +0000: New oral treatment for moderate to severe atopic dermatitis, CHMP, 18/09/2020 - News and press releases
EMA has recommended granting an extension of indication to Olumiant (baricitinib) to include the treatment of moderate to severe atopic dermatitis in... - Fri, 18 Sep 2020 10:00:00 +0000: First treatment for rare metabolic disorder alkaptonuria, CHMP, 18/09/2020 - News and press releases
EMA has recommended granting an extension of indication to Orfadin (nitisinone) to include the treatment of alkaptonuria in adult patients.This rare... - Fri, 18 Sep 2020 10:00:00 +0000: New treatment for children with chronic kidney disease, CHMP, 18/09/2020 - News and press releases
EMA has recommended granting an extension of indication for Velphoro (sucroferric oxyhydroxide) to include control of serum phosphorus levels in children... - Thu, 17 Sep 2020 09:30:00 +0000: IT systems unavailable from 18 to 20 September 2020, , 17/09/2020 - News and press releases
All European Medicines Agency (EMA) information technology (IT) systems apart from the corporate website (www.ema.europa.eu) will be temporarily...
MedWatch Safety Alert RSS Feed
- Thu, 17 Sep 2020 04:00:00 +0000: Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub Potency - MedWatch Safety Alerts RSS Feed
Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have - Wed, 16 Sep 2020 13:00:00 +0000: 2020 Medical Device Recalls - MedWatch Safety Alerts RSS Feed
List of Medical Device recalls in 2020. - Wed, 16 Sep 2020 04:00:00 +0000: Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris™ Syringe and Alaris™ PCA Modules Due to Potential Incorrect Display of Syringe Types and/or Sizes - MedWatch Safety Alerts RSS Feed
The Alaris System is an infusion system. If parts of the PCA or Syringe Modules are damaged, incorrect syringe details may show, leading to inaccurate infusions. - Mon, 14 Sep 2020 04:00:00 +0000: Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to Risk of Stuck or Unresponsive Keys - MedWatch Safety Alerts RSS Feed
The Alaris System is an infusion system. The PC Unit Keys may become stuck or unresponsive and may lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected device. - Mon, 14 Sep 2020 04:00:00 +0000: Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or Missing Battery Screws and A Broken Upper and Lower Hinge Posts and Membrane Frame - MedWatch Safety Alerts RSS Feed
The Alaris System Infusion Pump is the foundation of the infusion system. Multiple models are being recalled due to damaged IUI Connectors, loose or missing Battery Screws and broken upper and lower hinge posts and membrane frame.