EMEA-002956-PIP01-21 - paediatric investigation plan

Synthetic hypericin

Key facts

• Active Substance:
  Synthetic hypericin
• Therapeutic area:
  Oncology
• Decision number:
  P/0218/2021
• PIP number:
  EMEA-002956-PIP01-21
• Pharmaceutical form(s):
  Ointment
• Condition(s) / indication(s):
  Treatment of Cutaneous T-Cell Lymphoma
• Route(s) of administration:
  Topical use
• Contact for public enquiries:

  Soligenix NL B.V

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/06/2021

Decision

P/0218/2021 : EMA decision of 8 June 2021 on the granting of a product specific waiver for synthetic hypericin (EMEA-002956-PIP01-21)

AdoptedReference Number: EMA/301680/2021