Pharmacovigilance
Pharmacovigilance
| Product | Date | Safety information | Attachments |
|---|---|---|---|
| Prokinin® (Domperidone) | 2014-09-07 | New recommendations to minimise the cardiac risks .
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| Arzerra® (ofatumumab) | 2014-07-20 | change to safety information regarding update to hepatitis B virus reactivation warning . |
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| Arzerra® (ofatumumab) | 2014-07-20 | Safety update on a fatal infusion reaction reported in a patient with Chronic lymphocytic leukemia (CLL) who was treated with intravenous ofatumumab . |
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| Riacavilol® (Carvedilol) | 2014-07-09 | Important safety update of prescribing information for Carvidol® (Carvedilol)
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| Procoralan® (Ivabradine) | 2014-07-01 | Reminder on the Procoralan® (Ivabradine) conditions of use for the symptomatic treatment of chronic stable angina pectoris to avoid potentially dangerous bradycardia |
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| Carvidol® (Carvedilol) | 2014-06-05 | Important safety update of prescribing information for Carvidol® (Carvedilol) |
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| Vectibix® (Panitumumab) | 2014-05-27 | Rare cases of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis that have been reported in patients treated with Vectibix® (Panitumumab) |
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| Benlysta® (Belimumab) | 2014-05-11 | Two Post Marketing Reports, One Fatal, of Progressive Multifocal Leukoencephalopathy (PML) in Patients with Systemic Lupus Erythematosus (SLE) . |
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| Plasmex 6%® (Hydroxyethyl starch) | 2014-04-19 | New safety guidance for Plasmex 6%® (Hydroxyethyl starch) |
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| Plasmex 6%® (Hydroxyethyl starch) | 2014-04-19 |
New safety guidance for Plasmex 6%® (Hydroxyethyl starch) |