EMEA-000464-PIP01-08 - paediatric investigation plan

pasireotide

Key facts

• Active substance:
  pasireotide
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/75/2009
• PIP number:
  EMEA-000464-PIP01-08
• Pharmaceutical form(s):
  • Solution for injection
  • Powder and solvent for suspension for injection
• Condition(s) / indication(s):
  • Overproduction of pituitary ACTH
  • Pituitary dependant Cushing's disease
  • Pituitary dependant hyperadrenocorticism
• Route(s) of administration:
  • Subcutaneous use
  • Intramuscular use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  20/04/2009
• Compliance check done:
  No

Decision

P/75/2009: European Medicines Agency decision of 20 April 2009 on the granting of a product specific waiver for pasireotide (EMEA-000464-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliamen...

Adopted Reference Number: EMEA/218895/2009