Patient safety, news and press releases from EMA
- Fri, 29 Apr 2016 11:00:04 +0000: News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 April 2016 - News and press releases
Six medicines, including one new antibacterial recommended for authorisation in the EU; antiseptic gel for newborns receives positive scientific opinion for use outside the EU
- Fri, 29 Apr 2016 11:00:03 +0000: News and press releases: Boosting care for newborn babies in low-income countries - News and press releases
Umbipro to help prevent umbilical cord infections
- Fri, 29 Apr 2016 11:00:02 +0000: News and press releases: New medicine to help in the fight against antimicrobial resistance - News and press releases
Zavicefta is recommended for approval for patients with limited treatment options.
- Fri, 29 Apr 2016 11:00:01 +0000: News and press releases: New treatment for rare white blood cell cancer - News and press releases
Treatment of follicular lymphoma to be added to Gazyvaro’s approved uses
- Fri, 29 Apr 2016 11:00:00 +0000: News and press releases: EMA completes review of inhaled corticosteroids for chronic obstructive pulmonary disease - News and press releases
Review finds no differences between products in risk of pneumonia
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- Tue, 26 Apr 2016 21:30:00 +0000: Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall - Presence of Particulate Matter - MedWatch Safety Alert RSS Feed
Administration of a solution containing glass particulate matter may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves.
- Tue, 26 Apr 2016 13:00:00 +0000: Fluconazole (Diflucan): Drug Safety Communication - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy - MedWatch Safety Alert RSS Feed
Danish study shows possible increased risk of miscarriage. FDA advises cautious prescribing of oral fluconazole in pregnancy, until more is understood about this study.
- Wed, 20 Apr 2016 20:30:00 +0000: Covidien Oridion Labeled Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic: Recall - Risk of Thermal Damage - MedWatch Safety Alert RSS Feed
Thermal damage may cause fire, resulting in smoke inhalation and minor burns.
- Sat, 16 Apr 2016 15:42:00 +0000: Sterile Drug Products from Pharmakon Pharmaceuticals: Recall - Lack of Sterility Assurance - MedWatch Safety Alert RSS Feed
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
- Fri, 15 Apr 2016 12:22:00 +0000: March 2016 - MedWatch Safety Alert RSS Feed
Drug Safety Labeling Changes includes 35 products with revisions to Prescribing Information. Posted 04/15/2015