| Author (Corporate) | European Medicines Agency |
|---|---|
| Series Title | Press Release |
| Series Details | EMA/686491/2013 (08.11.13) |
| Publication Date | 08/11/2013 |
| Content Type | News |
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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), at its meeting on 4-7 November 2013, reviewed new information on the cancer medicine Iclusig (ponatinib) that suggests that side effects such as vascular occlusive events (blood clots obstructing the arteries or veins) occur at a higher rate than initially observed at the time of granting the European Union (EU) marketing authorisation in July 2013. Conditions related to thrombosis such as myocardial infarction (heart attack) are known side effects of Iclusig and the current EU product information mentions the risk of myocardial infarction, cerebral infarction (stroke) and related disorders. |
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| Source Link | http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/11/news_detail_001949.jsp&mid=WC0b01ac058004d5c1 |
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| Subject Categories | Health |
| Countries / Regions | Europe |
