EMEA-000078-PIP01-07-M08

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Overview

Product details for Mimpara
Invented nameMimpara
Active substance

Cinacalcet (hydrochloride)

Decision numberP/0128/2017
PIP numberEMEA-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 administrationOral use
PIP applicant

Amgen Europe B.V
United Kingdom
Tel.: +44 (0)1223 420305
E-mail: pipenquiry@amgen.com

Decision typePM: decision on the application for modification of an agreed PIP
Compliance check procedure numberEMEA-C-000078-PIP01-07-M08
Compliance check opinion date19/05/2017
Compliance check outcomePositive

Decision

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