P/82/2010 - paediatric investigation plan

Vorinostat

Key facts

• Active Substance:
  Vorinostat
• Therapeutic area:
  Oncology
• Decision number:
  P/82/2010
• PIP number:
  P/82/2010
• Pharmaceutical form(s):
  Capsule (hard)
• Condition(s) / indication(s):
  • Malignant pleural mesothelioma
  • Treatment of Cutaneous T-Cell Lymphoma
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Merck Sharp & Dohme Ltd

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  30/04/2010

Decision

P/82/2010: European Medicines Agency decision of of 30 April 2010 on the granting of a product specific waiver for vorinostat (EMEA-000805-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the European Parli...

AdoptedReference Number: EMA/262857/2010