EMEA-000126-PIP01-07 - paediatric investigation plan

pemetrexed disodium

Key facts

• Invented name:
  • Alimta
  • Alimta
• Active substance:
  pemetrexed disodium
• Therapeutic area:
  Oncology
• Decision number:
  P/34/2009
• PIP number:
  EMEA-000126-PIP01-07
• Pharmaceutical form(s):
  Powder for concentrate for solution for infusion
• Condition(s) / indication(s):
  • Carcinoma of the head and neck (Covered by class waiver: oropharyngeal epithelial carcinoma, excluding nasopharyngeal carcinoma)
  • Malignant pleural mesothelioma
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  24/02/2009
• Compliance check done:
  No

Decision

P/34/2009: European Medicines Agency decision of 24 February 2009 on the granting of a product-specific waiver for pemetrexed disodium (Alimta) (EMEA-000126-PIP01-07) in accordance with Regulation (EC) No 1901/2006 of th...

Adopted Reference Number: EMEA/90603/2009