EMEA-000404-PIP02-12 - paediatric investigation plan

Lapatinib ditosilate monohydrate

Key facts

• Invented name:
  • Tyverb
  • Tyverb
• Active substance:
  Lapatinib ditosilate monohydrate
• Therapeutic area:
  Oncology
• Decision number:
  P/0213/2012
• PIP number:
  EMEA-000404-PIP02-12
• Pharmaceutical form(s):
  • Film-coated tablet
  • Powder for oral suspension
• Condition(s) / indication(s):
  • Treatment of gastro oesophageal junction adenocarcinoma
  • Treatment of oesophageal adenocarcinoma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  28/09/2012
• Compliance check done:
  Não

Decision

P/0213/2012: EMA decision of 28 September 2012 on the granting of a product specific waiver for lapatinib (ditosylate monohydrate) (Tyverb), (EMEA-000404-PIP02-12)

Adopted Reference Number: EMA/492880/2012