EMEA-000052-PIP01-07-M03 - paediatric investigation plan

Vandetanib

Key facts

• Invented name:
  • Caprelsa
  • Caprelsa
• Active Substance:
  Vandetanib
• Therapeutic area:
  Oncology
• Decision number:
  P/0285/2013
• PIP number:
  EMEA-000052-PIP01-07-M03
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of medullary thyroid carcinoma
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  AstraZeneca AB (Sweden)

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/11/2013
• Compliance procedure number:
  EMEA-C-000052-PIP01-07-M03
• Compliance opinion date:
  20/06/2014
• Compliance outcome:
  Positive

Decision

P/0285/2013: EMA decision of 29 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for vandetanib (Caprelsa), (EMEA-000052-PIP01-07-M03)

AdoptedReference Number: EMA/659472/2013