EMEA-000369-PIP01-08 - paediatric investigation plan

Clazosentan

Key facts

• Active Substance:
  Clazosentan
• Therapeutic area:
  Neurology
• Decision number:
  P/109/2009
• PIP number:
  EMEA-000369-PIP01-08
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Sequelae of cerebrovascular disease induced by vasospasm
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  16/06/2009

Decision

P/109/2009: European Medicines Agency decision of 16 June 2009 on the granting of a product specific waiver for clazosentan (EMEA-000369-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliamen...

AdoptedReference Number: EMEA/351854/2009