EMEA-001503-PIP01-13 - paediatric investigation plan

Lanreotide acetate

Key facts

• Active substance:
  Lanreotide acetate
• Therapeutic area:
  Oncology
• Decision number:
  P/0302/2013
• PIP number:
  EMEA-001503-PIP01-13
• Pharmaceutical form(s):
  • Powder and solvent for prolonged-release suspension for injection
  • Solution for injection in pre-filled syringe
  • Powder for suspension for injection
• Condition(s) / indication(s):
  • Treatment of acromegaly
  • Treatment of gastrointestinal fistulae
  • Treatment of metastases to peritoneum
  • Treatment of pituitary gigantism
  • Treatment of pituitary neoplasms
• Route(s) of administration:
  • Intramuscular use
  • Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/11/2013
• Compliance check done:
  Ne

Decision

P/0302/2013: EMA decision of of 29 November 2013 on the granting of a product-specific waiver for lanreotide (acetate) (Somatuline LA and associated names) (EMEA-001503-PIP01-13)

Adopted Reference Number: EMEA-001503-PIP01-13