Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK, Breda, The Netherlands
Parsabiv 2.5 mg solution for injection.
Parsabiv 5 mg solution for injection.
Parsabiv 10 mg solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear colourless solution. |
Parsabiv 2.5 mg solution for injection: Each vial contains 2.5 mg of etelcalcetide (as hydrochloride) in 0.5 mL of solution. Each mL contains 5 mg etelcalcetide.
Parsabiv 5 mg solution for injection: Each vial contains 5 mg of etelcalcetide (as hydrochloride) in 1 mL of solution. Each mL contains 5 mg etelcalcetide.
Parsabiv 10 mg solution for injection: Each vial contains 10 mg of etelcalcetide (as hydrochloride) in 2 mL of solution. Each mL contains 5 mg etelcalcetide.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Etelcalcetide |
Etelcalcetide is a synthetic peptide calcimimetic agent which reduces PTH secretion through binding and activation of the calcium-sensing receptor. Etelcalcetide is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy. |
| List of Excipients |
|---|
|
Sodium chloride |
Parsabiv 2.5 mg solution for injection: Single use vial (type I glass) with stopper (fluoropolymer laminated elastomeric) and an aluminium seal with flip-off dust cover. Each vial contains 0.5 mL solution for injection.
Parsabiv 5 mg solution for injection: Single use vial (type I glass) with stopper (fluoropolymer laminated elastomeric) and an aluminium seal with flip-off dust cover. Each vial contains 1 mL solution for injection.
Parsabiv 10 mg solution for injection: Single use vial (type I glass) with stopper (fluoropolymer laminated elastomeric) and an aluminium seal with flip-off dust cover. Each vial contains 2 mL solution for injection.
Pack sizes of 1, 6, 12 and 42 vials.
Not all pack sizes may be marketed.
Amgen Europe B.V., Minervum 7061, 4817 ZK, Breda, The Netherlands
Parsabiv 2.5 mg solution for injection:
EU/1/16/1142/001 – 1 vial
EU/1/16/1142/002 – 6 vials
EU/1/16/1142/003 – 12 vials
EU/1/16/1142/004 – 42 vials
Parsabiv 5 mg solution for injection:
EU/1/16/1142/005 – 1 vial
EU/1/16/1142/006 – 6 vials
EU/1/16/1142/007 – 12 vials
EU/1/16/1142/008 – 42 vials
Parsabiv 10 mg solution for injection:
EU/1/16/1142/009 – 1 vial
EU/1/16/1142/010 – 6 vials
EU/1/16/1142/011 – 12 vials
EU/1/16/1142/012 – 42 vials
Date of first authorisation: 11 November 2016
| Drug | Countries | |
|---|---|---|
| PARSABIV | Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Singapore, Turkey, United Kingdom, United States |
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