Active ingredients: Cinacalcet
Mimpara 30 mg film-coated tablets.
Mimpara 60 mg film-coated tablets.
Mimpara 90 mg film-coated tablets.
Film-coated tablet (tablet).
Mimpara 30 mg film-coated tablets: Light green, oval (approximately 9.7 mm long and 6.0 mm wide), film-coated tablet marked “AMG” on one side and “30” on the other.
Mimpara 60 mg film-coated tablets: Light green, oval (approximately 12.2 mm long and 7.6 mm wide), film-coated tablet marked “AMG” on one side and “60” on the other.
Mimpara 90 mg film-coated tablets: Light green, oval (approximately 13.9 mm long and 8.7 mm wide), film-coated tablet marked “AMG” on one side and “90” on the other.
Each tablet contains 30 mg, 60 mg or 90 mg cinacalcet (as hydrochloride).
Excipient with known effect:
Mimpara 30 mg film-coated tablets: Each 30 mg tablet contains 2.74 mg of lactose.
Mimpara 60 mg film-coated tablets: Each 60 mg tablet contains 5.47 mg of lactose.
Mimpara 90 mg film-coated tablets: Each 90 mg tablet contains 8.21 mg of lactose.
For the full list of excipients, see section 6.1.
Cinacalcet is a calcimimetic agent which directly lowers PTH levels by increasing the sensitivity of the calcium sensing receptor to extracellular calcium. The reduction in PTH is associated with a concomitant decrease in serum calcium levels.
Tablet core:
Pre-gelatinised starch (maize)
Microcrystalline cellulose
Povidone
Crospovidone
Magnesium stearate
Colloidal anhydrous silica
Tablet coat:
Carnauba wax
Opadry II green: (Lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD&C Blue (E132), iron oxide yellow (E172))
Opadry clear: (Hypromellose, macrogol)
Aclar/PVC/PVAc/Aluminium blister containing 14 tablets. Pack sizes of 1 blister (14 tablets), 2 blisters (28 tablets), 6 blisters (84 tablets) per carton.
High Density Polyethylene (HDPE) bottle with a cotton coil, and a child-resistant polypropylene cap with an induction seal, packed into a carton. Each bottle contains 30 tablets.
Not all pack sizes may be marketed.
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
EU/1/04/292/001 – 30 mg carton with 14 tablets
EU/1/04/292/002 – 30 mg carton with 28 tablets
EU/1/04/292/003 – 30 mg carton with 84 tablets
EU/1/04/292/004 – 30 mg bottle with 30 tablets
EU/1/04/292/005 – 60 mg carton with 14 tablets
EU/1/04/292/006 – 60 mg carton with 28 tablets
EU/1/04/292/007 – 60 mg carton with 84 tablets
EU/1/04/292/008 – 60 mg bottle with 30 tablets
EU/1/04/292/009 – 90 mg carton with 14 tablets
EU/1/04/292/010 – 90 mg carton with 28 tablets
EU/1/04/292/011 – 90 mg carton with 84 tablets
EU/1/04/292/012 – 90 mg bottle with 30 tablets
Date of first authorisation: 22 October 2004
Date of latest renewal: 23 September 2009