Patient safety, news and press releases from EMA
- Wed, 01 Jul 2015 16:30:00 +0000: News and press releases: Regulatory information – Mandatory use of common repository for human centralised procedures as of today – News and press releases
Companies now to submit their applications to the European Medicines Agency only
- Wed, 01 Jul 2015 13:30:00 +0000: News and press releases: Regulatory information – Electronic application becomes mandatory today – News and press releases
EMA application forms should be used for all human and veterinary centralised procedure applications as of 1 July 2015
- Wed, 01 Jul 2015 11:00:00 +0000: News and press releases: Staying safe when buying medicines online – News and press releases
EU-wide logo to protect patients from falsified medicines
- Tue, 30 Jun 2015 14:00:00 +0000: News and press releases: Facilitating the development of advanced therapies – News and press releases
Joint workshop with International Society for Cellular Therapy to take place on 25 September 2015 in Seville, Spain
- Mon, 29 Jun 2015 14:45:00 +0000: News and press releases: Update on publication of clinical data – News and press releases
EMA publishes video and presentations from the 24 June webinar on the implementation of its transparency policy
MedWatch Safety Alert RSS Feed
- Thu, 02 Jul 2015 15:10:00 +0000: Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall – Intake Port Blockage – MedWatch Safety Alert RSS Feed
Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.
- Wed, 01 Jul 2015 14:40:00 +0000: Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality – MedWatch Safety Alert RSS Feed
Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.
- Wed, 01 Jul 2015 14:00:00 +0000: Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication – FDA Evaluating Potential Risk of Serious Side Effects – MedWatch Safety Alert RSS Feed
FDA investigating the safety of codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for slowed or difficult breathing.
- Wed, 01 Jul 2015 04:00:00 +0000: FLOW-i Anesthesia Systems by Maquet: Class I Recall – Dislodged Patient Cassette May Stop Patient Ventilation – MedWatch Safety Alert RSS Feed
May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.
- Wed, 24 Jun 2015 16:10:00 +0000: Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication – Permanent Skin Color Changes – MedWatch Safety Alert RSS Feed
New warning added to drug label to describe risk of chemical leukoderma.
chemical leukoderma, have been associated with the use of the Daytrana patch.