EMEA-000078-PIP01-07-M08 - paediatric investigation plan

cinacalcet hydrochloride

Key facts

• Invented name:
  • Mimpara
  • Mimpara
• Active Substance:
  cinacalcet hydrochloride
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0128/2017
• PIP number:
  EMEA-000078-PIP01-07-M08
• Pharmaceutical form(s):
  • Film-coated tablet
  • Capsule (hard)
  • Age-appropriate dosage form, other
• Condition(s) / indication(s):
  • Treatment of parathyroid carcinoma
  • Treatment of primary hyperparathyroidism
  • Treatment of secondary hyperparathyroidism in patients with end-stage renal disease
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Amgen Europe B.V

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/05/2017
• Compliance procedure number:
  EMEA-C-000078-PIP01-07-M08
• Compliance opinion date:
  19/05/2017
• Compliance outcome:
  Positive

Decision

P/0128/2017: EMA decision of 12 May 2017 on the acceptance of a modification of an agreed paediatric investigation plan for cinacalcet (hydrochloride) (Mimpara), (EMEA-000078-PIP01-07-M08)

AdoptedReference Number: EMA/278983/2017