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Suggestions

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.

Defra (Dimethyl fumarate)

Updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia.

Fingolimod SPC (fingolimod)

Updated recommendations to minimize the risk of drug-induced liver injury (DILI).

Tecfidera (dimethyl fumarate)

Updated recommendations in the light of cases of progressive multifocal leukoencephalopathy (PML) in the setting of mild lymphopenia

Gilenya (fingolimod)

Updated recommendations to minimize the risk of drug-induced liver injury (DILI)

Haldol (Haloperidol)

HALDOL® 5mg/ml (HALOPERIDOL) solution for injection: Incorrect information on route of administration on outer carton

Esbriet (pirfenidone)

Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)

Levon (Levofloxacin Hemihydrate) / Moxiflox (Moxifloxacin)

Systemic and inhaled fluoroquinolones: warning about new risk of heart valve regurgitation/incompetence.

Tarivid (Ofloxacin) / Tavanic (Levofloxacin)

Systemic and inhaled fluoroquinolones: warning about new risk of heart valve regurgitation/incompetence.

Revlimid® (Lenalidomide)

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