Decision

Sebetralstat in the treatment of hereditary angioedema (HAE) attacks

EAMS scientific opinion issued to KalVista Pharmaceuticals Limited for Sebetralstat in the treatment of hereditary angioedema (HAE) attacks in adult and adolescents aged 12 years and older.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 24 March 2025

Documents

Sebetralstat: Public Assessment Report (PAR)

PDF, 531 KB, 3 pages

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Sebetralstat: Treatment protocol Information for healthcare professionals

PDF, 654 KB, 12 pages

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Sebetralstat: Treatment protocol Information for patients

PDF, 387 KB, 5 pages

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Sebetralstat: Information for NHS Medical Directors

PDF, 450 KB, 4 pages

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Sebetralstat: Treatment Protocol Information on Pharmacovigilance System

PDF, 580 KB, 4 pages

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Details

For the full EAMS indication please see section 4.1 of the Treatment protocol: Information for healthcare professionals.

The scientific opinion includes:

• a public assessment report (PAR)
• a treatment protocol:
  • for healthcare professionals
  • for patients
  • on the pharmacovigilance system
• Information for NHS Medical Directors

Published 24 March 2025