EMEA-002472-PIP02-19 - paediatric investigation plan

genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII (beremagene geperpavec)

Key facts

• Active substance:
  genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII (beremagene geperpavec)
• Therapeutic area:
  Dermatology
• Decision number:
  P/0227/2019
• PIP number:
  EMEA-002472-PIP02-19
• Pharmaceutical form(s):
  Gel
• Condition(s) / indication(s):
  Treatment of dystrophic epidermolysis bullosa
• Route(s) of administration:
  Topical use
• Decision type:
  RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
• Decision date:
  08/07/2019
• Compliance check done:
  No

Decision

P/0227/2019: EMA decision of 8 July 2019 on the refusal of a paediatric investigation plan for genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII (EMEA-002472-PIP02-19)

Adopted Reference Number: EMA/380136/2019