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Product Date Safety information Attachments
Protelos® - Strontium ranelate 2013-05-27

Increased risk of myocardial infarction ​

Miacalcic® - Calcitonin 2013-05-11

increased risk of malignancies with long term calcitonin use  ​

Solpadeine® - Paracetamol, Caffeine, Codeine Phosphate 2013-05-07

The use of codeine containing products for children after tonsillectomy and /or adenoidectomy surgery  

Vastarel® - Trimetazidine 2013-05-01

Outcome of the Benefit-Risk Re-evaluation of Trimetazidine  ​

AVASTIN® - Bevacizumab 2013-04-07

Cases of Necrotizing Fasciitis Reported with AVASTIN  ​

MabThera® - Rituximab 2013-04-01

Risk of Toxic Epidermal Necrolysis And Stevens-Johnson-Syndrome  ​​

SPRYCEL® - Dasatinib 2013-01-27

Risk of (PAH) Pulmonary Arterial Hypertension ​​

Valdoxan® - Agomelatine 2013-01-21

Risk of hepatotoxicity with agomelatine  ​​

Arava® - leflunomide 2012-12-23

Risk of hepatotoxicity

Risk of serious birth defects  ​

Wellbutrin®/Zyban® - bupropion 2012-12-15

Increased risk of congenital cardiovascular malformations ​​

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