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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.

Revlimid® (Lenalidomide) 2020-10-21

Notification of typographical error in the Revlimid® (Lenalidomide) Hard Capsules Patient Information Leaflet (PIL)

Motilium (Domperidone) 2020-10-18

Removal of the paediatric posology and reminder of indication and contraindications related to serious cardiac side-effects

Levofloxacin Sandoz (Levofloxacin) 2020-09-13

Systemic fluoroquinolones: risk of heart valve regurgitation

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