AstraZeneca Pharma receives CDSCO’s permission for Tremelimumab Concentrate

02 Jun 2023 Evaluate

AstraZeneca Pharma India has received permission in Form CT20 to Import for sale and distribution of Tremelimumab (Imjudo) Concentrate for solution for infusion 20 mg/ml (25 mg/1.25 ml and 300 mg/15 ml presentations in single dose vials) administered through intravenous route from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India.

Through this approval, Tremelimumab (Imjudo) in combination with Durvalumab (Imfinzi) is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC). The receipt of this permission paves way for the launch of Tremelimumab (Imjudo) solution of 20 mg/ml (25 mg/1.25 ml and 300 mg/15 ml presentations in single dose vials) in India for the specified indication, subject to the receipt of related statutory approvals, if any.

AstraZeneca Pharma India is a global biopharmaceutical company. The company is engaged in the discovery, development and commercialization of medicines for core areas of healthcare, including cardiovascular/metabolic disease, cancer and respiratory, inflammatory and autoimmune disease. The company operates through two segments Healthcare and Clinical Trial.


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