PRAC May 2023 – Restrictions on the use of fluoroquinolone antibiotics and new safety information for fluoroquinolone antibiotics and Gavreto

During its May 2023 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), is reminding healthcare professionals that the use of fluoroquinolone antibiotics given by mouth, injection or inhalation, is restricted due to the risk of disabling, long-lasting and potentially irreversible side effects. The PRAC discussed direct healthcare professional communications (DHPCs) containing important information on fluoroquinolone antibiotics and Gavreto.

Sarclisa

Active substance

Brukinsa

Active substance

Hepcludex

Active substance bulevirtide
Holder     Gilead Sciences Belgium B.V.
Status Running
Indication for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDVRNA positive adult patients with compensated liver disease
Public documents

Give your opinion on a genetically modified medicine for the treatment of Duchenne Muscular Dystrophy

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New system for financing the surveillance of the medical devices market

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Ebvallo CUP-202227

Active substance

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