By: IPP Bureau
Last updated : May 04, 2023 11:44 am
The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India
AstraZeneca Pharma India Limited has received a permission in Form CT-20 to import for sale and distribution of Trastuzumab deruxtecan (Enhertu) 100mg/5mL vial lyophilized powder for concentrate for solution for infusion from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India.
Through this approval, Trastuzumab deruxtecan (Enhertu) is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen.
The receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India for the specified indication, subject to the receipt of related statutory approvals, if any.