EMEA-001612-PIP01-14 - paediatric investigation plan

Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113)

Key facts

• Invented name:
  Transvax
• Active substance:
  Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113)
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0338/2014
• PIP number:
  EMEA-001612-PIP01-14
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  22/12/2014
• Compliance check done:
  No

Decision

P/0338/2014: EMA decision of 22 December 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glyc...

Adopted Reference Number: EMA/713528/2014