EMEA-001056-PIP02-12-M01 - paediatric investigation plan

velmanase alfa

Key facts

• Invented name:
  Lamzede
• Active substance:
  velmanase alfa
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0407/2020
• PIP number:
  EMEA-001056-PIP02-12-M01
• Pharmaceutical form(s):
  Powder for solution for injection
• Condition(s) / indication(s):
  Treatment of alpha-mannosidosis
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  23/10/2020
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-001056-PIP02-12-M01
• Compliance opinion date:
  23/04/2021
• Compliance outcome:
  Positive

Decision

P/0407/2020: EMA decision of 23 October 2020 on the acceptance of a modification of an agreed paediatric investigation plan for velmanase alfa (Lamzede), (EMEA-001056-PIP02-12-M01)

Adopted Reference Number: EMA/493358/2020