Zolgensma - direct healthcare professional communication (DHPC)

Onasemnogene abeparvovec

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): ZOLGENSMA (onasemnogene abeparvovec) - Fatal cases of acute liver failure

Dissemination date: 16/02/2023

Key facts

• Medicine name:
  Zolgensma
• Active substance:
  Onasemnogene abeparvovec
• Therapeutic area (MeSH):
  Muscular Atrophy, Spinal
• Procedure number:
  EMEA/H/C/004750/II/0033/G
• Regulatory outcome:
  Variation
• DHPC type:
  Adverse event
• Human ATC codes:
  M09AX09
• Dissemination date:
  16/02/2023