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News Feeds
Patient safety, news and press releases from EMA
- Fri, 23 Jan 2015 12:00:03 +0000: News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 2015 – Patient safety, news and press releases: human and vet
Seven new medicines recommended for approval
- Fri, 23 Jan 2015 12:00:02 +0000: News and press releases: GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies – Patient safety, news and press releases: human and vet
Medicines considered critically important for patients to remain available
- Fri, 23 Jan 2015 12:00:01 +0000: News and press releases: Saxenda recommended for approval in weight management in adults – Patient safety, news and press releases: human and vet
Medicine to be used in addition to reduced-calorie diet and physical activity
- Wed, 21 Jan 2015 15:15:00 +0000: News and press releases: Regulatory information – Paediatric guidance revised to reflect changes to European Commission guideline – Patient safety, news and press releases: human and vet
Documents relate to submission of applications, re-examination and compliance check procedures
- Wed, 21 Jan 2015 15:00:00 +0000: News and press releases: New international standard to improve safety of medicines – Patient safety, news and press releases: human and vet
New EMA guide will help industry and regulatory authorities to implement changes
MedWatch Safety Alert RSS Feed
- Fri, 23 Jan 2015 15:48:00 +0000: 0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall – Particulate Matter – MedWatch Safety Alert RSS Feed
Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.
- Wed, 21 Jan 2015 16:00:00 +0000: Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication – Reports of Serious Injuries – MedWatch Safety Alert RSS Feed
Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling.
- Wed, 14 Jan 2015 05:00:00 +0000: Simulated IV Solutions from Wallcur: CDER Statement- FDA’s Investigation into Patients being Injected – MedWatch Safety Alert RSS Feed
Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products.
- Sat, 10 Jan 2015 17:00:00 +0000: IV Solutions from Wallcur of San Diego: CDER Statement – FDA Warns Health Care Professionals Not to Inject Patients – MedWatch Safety Alert RSS Feed
UPDATED 01/10/2015 Wallcur Practi-IV solutions bags are recalled.
- Fri, 09 Jan 2015 17:20:00 +0000: Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication – FDA Review of Possible Risks of Pain Medicine Use During Pregnancy – MedWatch Safety Alert RSS Feed
Pregnant women urged to discuss all medicines with their health care professionals before using them.