AstraZeneca Pharma India receives permission for paediatric drug
Drug Approval

AstraZeneca Pharma India receives permission for paediatric drug

It paves way for the launch of Selumetinib 10 mg & 25 mg capsule in India, subject to the receipt of related statutory approvals and licenses

  • By IPP Bureau | September 26, 2021

AstraZeneca Pharma India has received import and market permission in Form CT-20 from the Drugs Controller General of India for Selumetinib 10 mg & 25 mg capsule.

Selumetinib 10 mg & 25 mg capsule is indicated for the treatment of paediatric patients 3 years of age and older with neurofibromatosis type 1 (NF1) and who have symptomatic, inoperable plexiform neurofibromas (PN).

It paves way for the launch of Selumetinib 10 mg & 25 mg capsule in India, subject to the receipt of related statutory approvals and licenses.

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