Pharmacovigilance Risk Assessment Committee (PRAC)

EMA committee recommends restrictions on fluoroquinolone, quinolone antibiotics

Antibiotics, Birth Defects, Blockbusters, Bones, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), FDA, FDA/Regulatory, Fluoroquinolones, Integrase inhibitors, Muscles, Nervous System, Pharmacovigilance Risk Assessment Committee (PRAC), Quinolone, Tendons

The EMA’s risk assessment committee recommended restrictions on the use of the broad-spectrum antibiotics.

October 5, 2018/by Reuters Health

EMA warns hep C drugs could reactivate hep B

Blockbusters, EMA, FDA, FDA/Regulatory, Health, Hepatitis B, Hepatitis C, Labeling, Liver Cancer, Pharmacovigilance Risk Assessment Committee (PRAC), Reactivation, Shares

The European Medicines Agency warned for the second time in 2016 that some of the top-selling hepatitis C treatments could reactivate hepatitis B in patients.

December 2, 2016/by Reuters Health