Composition

Mircera 50 micrograms/0.3 mL solution for injection in pre-filled syringe. One pre-filled syringe contains 50 micrograms of Methoxy polyethylene glycol-epoetin beta* at a concentration of 167 micrograms/mL. The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation. *Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG). The potency of methoxy polyethene glycol-epoetin beta should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class Excipients: L- Methionine 0.447 mg/0.3 mL, Sodium sulphate anhydrous1.704 mg/0.3 mL, Sodium dihydrogen phosphate monohydrate 0.414 mg/0.3 mL, Mannitol 9.000 mg/0.3 mL, Poloxamer 188 0.030 mg/0.3 mL, Hydrochloric acid diluted q.s (pH 6.2), Sodium hydroxide diluted solution q.s (Ph 6.2), Water for injection q.s ad total weight  

ATC Code/ATCvet Code

B03XA03  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

0.3 mL (50 mcg) x 1’s (in pre-filled syringe)  

Product Description

Solution for injection in pre-filled syringe. The solution is clear and colourless to slightly yellowish

Manufacturer Name

Roche Diagnostics GmbH

Manufacturer Country

GERMANY  

Approval Date

2023-07-03  

Expiry Date

2028-07-02