MIMPARA Film-coated tablet Ref.[6682] Active ingredients: Cinacalcet

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands

Product name and form

Mimpara 30 mg film-coated tablets.

Mimpara 60 mg film-coated tablets.

Mimpara 90 mg film-coated tablets.

Pharmaceutical Form

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.

Qualitative and quantitative composition

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.

Active Ingredient Description
Cinacalcet

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.

List of Excipients

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)

Pack sizes and marketing

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.

Marketing authorization holder

Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands

Marketing authorization dates and numbers

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

Drugs

Drug Countries
MIMPARA Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Ireland, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, Turkey, United Kingdom

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