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

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