EMEA-002491-PIP02-19 - paediatric investigation plan

ciclosporin

Key facts

• Active Substance:
  ciclosporin
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0293/2019
• PIP number:
  EMEA-002491-PIP02-19
• Pharmaceutical form(s):
  Eye drops, solution
• Condition(s) / indication(s):
  Treatment of dry eye disease
• Route(s) of administration:
  Ocular use
• Contact for public enquiries:

  Sun Pharmaceutical Industries Europe BV

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/08/2019

Decision

P/0293/2019: EMA decision of 14 August 2019 on the granting of a product specific waiver for ciclosporin (EMEA-002491-PIP02-19)

AdoptedReference Number: EMA/395098/2019