EMEA-002690-PIP01-19 - paediatric investigation plan

6 fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2- methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one

Key facts

• Active Substance:
  6 fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2- methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one
• Therapeutic area:
  Oncology
• Decision number:
  P/0091/2020
• PIP number:
  EMEA-002690-PIP01-19
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of lung cancer
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Amgen Europe B.V

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  18/03/2020

Decision

P/0091/2020: EMA decision of 18.03.20 on the granting of a product specific waiver for 6 fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4- methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2- methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3- d]pyrimidin-2(1H)-one

AdoptedReference Number: EMA/115514/2020