Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
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. |
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) Tablet coat: Carnauba wax |
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
| Drug | Countries | |
|---|---|---|
| MIMPARA | Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, Turkey, United Kingdom |
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