Safety-Related Labeling Changes

"Class I (immediate) hypersensitivity reactions Pregnancy risk related to carbamazepine and Risk in women of childbearing potential hyperammonaemia"

Trade Name

Tegretol

Updated Section

"4.4 Special warnings and precautions for use 4.6 Fertility, pregnancy and lactation 4.8 Undesirable effects"

Month

Mar,2024