EMEA-002266-PIP01-17 - paediatric investigation plan

recombinant human acid ceramidase (RVT-801)

Key facts

• Active substance:
  recombinant human acid ceramidase (RVT-801)
• Therapeutic area:
  Other
• Decision number:
  P/0319/2018
• PIP number:
  EMEA-002266-PIP01-17
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  Farber disease
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  12/09/2018
• Compliance check done:
  No

Decision

P/0319/2018: EMA decision of 12 September 2018 on the agreement of a paediatric investigation plan and on the granting of a waiver for recombinant human acid ceramidase (RVT-801) (EMEA-002266-PIP01-17)

Reference Number: EMA/540506/2018