EMEA-000078-PIP01-07-M08

Key facts

Invented name
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 formulation
Condition(s) / indication(s)
  • Treatment of secondary hyperparathyroidism in patients with end-stage renal disease
  • Treatment of primary hyperparathyroidism
  • Treatment of parathyroid carcinoma
Route(s) of administration
Oral use
Contact for public enquiries
Amgen Europe B.V
United Kingdom
Tel.: +44 (0)1223 420305
E-mail: pipenquiry@amgen.com
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000078-PIP01-07-M08
Compliance opinion date
19/05/2017
Compliance outcome
positive

Decision

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