EMEA-002074-PIP01-16 - paediatric investigation plan

Ramucirumab

Key facts

• Invented name:
  • Cyramza
  • Cyramza
• Active Substance:
  Ramucirumab
• Therapeutic area:
  Oncology
• Decision number:
  P/0282/2017
• PIP number:
  EMEA-002074-PIP01-16
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of gastric cancer and gastro-oesophageal junction adenocarcinoma
  • Treatment of intestinal malignant neoplasms
  • Treatment of liver cancer
  • Treatment of lung malignant neoplasms
  • Treatment of urinary tract malignant neoplasm
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Eli Lilly and Company Limited

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  04/10/2017

Decision

P/0282/2017: EMA decision of 4 October 2017 on the granting of a product specific waiver for ramucirumab (Cyramza), (EMEA-002074-PIP01-16)

AdoptedReference Number: EMA/565636/2017