ACTIVE SUBSTANCE / INN

CINACALCET

Brand name(s): Mimpara, Cinacalcet Accordpharma, Cinacalcet Viatris (previously Cinacalcet Mylan), Parareg

EMA LISTED

WITHDRAWN

AUTHORISED

Hyperparathyroidism, Secondary;Hypercalcemia

Hypercalcemia;Parathyroid Neoplasms;Hyperparathyroidism

ACTIVE SUBSTANCE

Cinacalcet

REGULATORS

EMA

SPONSORS / MAH

Mylan Pharmaceuticals Limited, Amgen Europe B.V., Dompé Biotec S.p.A.

TOTAL APPLICATIONS

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Cinacalcet Viatris (previously Cinacalcet Mylan)	Mylan Pharmaceuticals Limited	Authorised	19/11/2015	Hyperparathyroidism, Secondary;Hypercalcemia
Cinacalcet Accordpharma	Accord Healthcare S.L.U.	Authorised	03/04/2020	Hyperparathyroidism
Mimpara	Amgen Europe B.V.	Authorised	22/10/2004	Hypercalcemia;Parathyroid Neoplasms;Hyperparathyroidism
Parareg	Dompé Biotec S.p.A.	Withdrawn	22/10/2004	Hypercalcemia;Parathyroid Neoplasms;Hyperparathyroidism

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