Pharmacovigilance
Product | Date | Safety information | Attachments |
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Procoralan® (Ivabradine) |
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) |
Important safety update of prescribing information for Carvidol® (Carvedilol) |
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Vectibix® (Panitumumab) |
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) |
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) |
New safety guidance for Plasmex 6%® (Hydroxyethyl starch) |
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Plasmex 6%® (Hydroxyethyl starch) |
New safety guidance for Plasmex 6%® (Hydroxyethyl starch) |
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Valdoxan® - Agomelatine |
New contraindication for use and a reminder of importance of liver function monitoring. CLICK HERE |
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Roaccutane® - Isotretinoin |
Pregnancy Prevention Program and Safety Information about Roaccutane®. |
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VIREAD ® - Tenofovir |
Possible presence of silicone rubber in the above listed product and lots. |
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Zelboraf® - Vemurafenib |
Risk of liver injury reported with Zelboraf®. |