Adenovirus-mediated Herpes simplex virus-thymidine kinase gene - paediatric investigation plan

adenovirus-mediated Herpes simplex virus-thymidine kinase gene

Key facts

• Active Substance:
  adenovirus-mediated Herpes simplex virus-thymidine kinase gene
• Therapeutic area:
  Oncology
• Decision number:
  P/28/2008
• PIP number:
  Adenovirus-mediated Herpes simplex virus-thymidine kinase gene
• Pharmaceutical form(s):
  Concentrate for solution for injection
• Condition(s) / indication(s):
  Treatment of high-grade glioma
• Route(s) of administration:
  Intracerebral use
• Contact for public enquiries:

  Ark Therapeutics Ltd

  E-mail: [e-mail]; Country: United Kingdom; Phone: [phone]; Fax: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  23/05/2008

Decision

P/28/2008: European medicines agency decision of 23 May 2008 on the application for agreement of a Paediatric Investigation Plan for adenovirus-mediated Herpes simplex virus-thymidine kinase gene (EMEA-000140-PIP01-07) i...

AdoptedReference Number: EMEA/259189/2008