Tecovirimat SIGA - direct healthcare professional communication (DHPC)

tecovirimat monohydrate

About

This direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date.

Documents

Direct healthcare professional communication (DHPC) : Tecovirimat SIGA (tecovirimat monohydrate): restriction of indication due to lack of efficacy shown in randomised clinical trials in patients with mpox

Dissemination date: 11/05/2026

Key facts

• Medicine name:
  Tecovirimat SIGA
• Active substance:
  tecovirimat monohydrate
• Therapeutic area (MeSH):
  • Poxviridae Infections
  • Cowpox
  • Monkeypox
  • Vaccinia
  • Smallpox
• Procedure number:
  EMA/REF/0000287477
• Regulatory outcome:
  Variation
• DHPC type:
  Restriction of indication
• Human ATC codes:
  J05AX24
• Dissemination date:
  11/05/2026