Pharmacovigilance
Product | Date | Safety information | Attachments |
---|---|---|---|
Cilest® - Ethinylestradiol, Norgestimate |
The reason for the recall is that dissolution testing of norgestimate. |
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TYKERB® - Lapatinib |
Comparative data have shown that Lapatinib based regimens are less effective than trastuzumab based regimens in certain settings. |
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Plavix® - Clopidogrel |
Regarding Bleeding Risk with Plavix in Atrial Fibrillation Patients. |
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Curacne® - Isotretinoin |
Pregnancy Prevention Program |
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ROACCUTANE®- Isotretinoin |
Pregnancy Prevention Program |
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Tysabri® - Connect |
Risk of progressive multifocal leukoencephalopathy PML |
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Protelos® - Strontium ranelate |
Increased risk of myocardial infarction |
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Miacalcic® - Calcitonin |
increased risk of malignancies with long term calcitonin use |
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Solpadeine® - Paracetamol, Caffeine, Codeine Phosphate |
The use of codeine containing products for children after tonsillectomy and /or adenoidectomy surgery |
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Vastarel® - Trimetazidine |
Outcome of the Benefit-Risk Re-evaluation of Trimetazidine |