EMEA-003028-PIP01-21 - paediatric investigation plan

Ociperlimab

Key facts

• Active Substance:
  Ociperlimab
• Therapeutic area:
  Oncology
• Decision number:
  P/0354/2021
• PIP number:
  EMEA-003028-PIP01-21
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Treatment of breast cancer
  • Treatment of cervical cancer
  • Treatment of endometrial carcinoma
  • Treatment of gastric and gastroesophageal junction adenocarcinoma
  • Treatment of head and neck epithelial malignant neoplasms
  • Treatment of hepatocellular carcinoma
  • Treatment of intestinal malignant neoplasms
  • Treatment of lung cancer
  • Treatment of oesophageal carcinoma
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  BeiGene Ireland Limited

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/09/2021

Decision

P/0354/2021 : EMA decision of 8 September 2021 on the granting of a product specific waiver for ociperlimab (EMEA-003028-PIP01-21)

AdoptedReference Number: EMA/440077/2021