EMEA-001998-PIP01-16 - paediatric investigation plan

ciclosporin

Key facts

• Active Substance:
  ciclosporin
• Therapeutic area:
  Ophthalmology
• Decision number:
  P/0305/2016
• PIP number:
  EMEA-001998-PIP01-16
• Pharmaceutical form(s):
  Eye drops, emulsion
• Condition(s) / indication(s):
  Treatment of dry eye disease
• Route(s) of administration:
  Ocular use
• Contact for public enquiries:

  Drug Delivery Solutions ApS

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/11/2016

Decision

P/0305/2016: EMA decision of 4 November 2016 on the granting of a product-specific waiver for ciclosporin, (EMEA-001998-PIP01-16)

AdoptedReference Number: EMA/501922/2008