Pharmacovigilance
Pharmacovigilance
| Product | Date | Safety information | Attachments |
|---|---|---|---|
| Fingolimod SPC (fingolimod) | 2021-01-13 | Updated recommendations to minimize the risk of drug-induced liver injury (DILI). |
|
| Tecfidera (dimethyl fumarate) | 2021-01-12 | Updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia |
|
| Gilenya (fingolimod) | 2021-01-10 | Updated recommendations to minimize the risk of drug-induced liver injury (DILI) |
|
| Haldol (Haloperidol) | 2020-12-27 | HALDOL® 5mg/ml (HALOPERIDOL) solution for injection: Incorrect information on route of administration on outer carton |
|
| Esbriet (pirfenidone) | 2020-12-14 | Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI) |
|
| Levon (Levofloxacin Hemihydrate) / Moxiflox (Moxifloxacin) | 2020-11-19 | Systemic and inhaled fluoroquinolones: warning about new risk of heart valve regurgitation/incompetence. |
|
| Tarivid (Ofloxacin) / Tavanic (Levofloxacin) | 2020-11-05 | Systemic and inhaled fluoroquinolones: warning about new risk of heart valve regurgitation/incompetence. |
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| Revlimid® (Lenalidomide) | 2020-10-21 | Notification of typographical error in the Revlimid® (Lenalidomide) Hard Capsules Patient Information Leaflet (PIL) |
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| Motilium (Domperidone) | 2020-10-18 | Removal of the paediatric posology and reminder of indication and contraindications related to serious cardiac side-effects |
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| Levofloxacin Sandoz (Levofloxacin) | 2020-09-13 | Systemic fluoroquinolones: risk of heart valve regurgitation |
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