EMEA-003449-PIP01-23 - paediatric investigation plan

modified, recombinant version of the human myeloid-derived growth factor

Key facts

• Active substance:
  modified, recombinant version of the human myeloid-derived growth factor
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0431/2023
• PIP number:
  EMEA-003449-PIP01-23
• Pharmaceutical form(s):
  Powder for solution for infusion
• Condition(s) / indication(s):
  Treatment of ischaemic coronary artery disorders
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Compliance check done:
  No

Decision

P/0431/2023 : EMA decision of on the granting of a product specific waiver for modified recombinant version of the human myeloid-derived growth factor (EMEA-003449-PIP01-23)

Adopted Reference Number: EMA/424754/2023