Safety-Related Labeling Changes

"Multiple safety updates including; reproductive system neoplasms, and abdominal distension Data on a limited number ofexposed pregnancies indicate no increased risks ofmalformation orfoeto/neonatal toxicity "

Trade Name

Ovitrelle

Updated Section

"4.4 Special Warnings and Special Precautions for Use 4.6. Fertility, pregnancy and lactation 4.8 Undesirable effects"

Month

Jul, 2024