EMEA-000097-PIP01-07 - paediatric investigation plan

Panobinostat as panobinostat lactate salt

Key facts

• Active Substance:
  Panobinostat as panobinostat lactate salt
• Therapeutic area:
  Oncology
• Decision number:
  P/6/2008
• PIP number:
  EMEA-000097-PIP01-07
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  Cutaneous T-cell lymphoma (including ICD-10 codes C84.0 (mycosis fungoides) and C84.1 (Sezary's Disease)
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  01/02/2008

Decision

P/6/2008: European medicines agency decision of 1 February 2008 on the application for product specific waiver for Panobinostat as panobinostat lactate salt EMEA-000097-PIP01-07 in accordance with Regulation (EC) No 1901...

AdoptedReference Number: EMEA/43569/2008