Pharmacovigilance
| Product | Date | Safety information | Attachments |
|---|---|---|---|
| Sclera (Dimethyl fumarate) |
Updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia. |
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| Defra (Dimethyl fumarate) |
Updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia. |
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| Fingolimod SPC (fingolimod) |
Updated recommendations to minimize the risk of drug-induced liver injury (DILI). |
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| Tecfidera (dimethyl fumarate) |
Updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia |
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| Gilenya (fingolimod) |
Updated recommendations to minimize the risk of drug-induced liver injury (DILI) |
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| Haldol (Haloperidol) |
HALDOL® 5mg/ml (HALOPERIDOL) solution for injection: Incorrect information on route of administration on outer carton |
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| Esbriet (pirfenidone) |
Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI) |
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| Levon (Levofloxacin Hemihydrate) / Moxiflox (Moxifloxacin) |
Systemic and inhaled fluoroquinolones: warning about new risk of heart valve regurgitation/incompetence. |
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| Tarivid (Ofloxacin) / Tavanic (Levofloxacin) |
Systemic and inhaled fluoroquinolones: warning about new risk of heart valve regurgitation/incompetence. |
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| Revlimid® (Lenalidomide) |
Notification of typographical error in the Revlimid® (Lenalidomide) Hard Capsules Patient Information Leaflet (PIL) |
