*** Disclaimer: This Database is still undergoing update on daily basis to prevent errors, discrepancies, and missing records. Please Contact FDIC@nafdac.gov.ng for enquires ***

Product Details

Mircera 75mcg

Methoxy polyethylene glycol-epoetin beta
75 mcg/0.3 mL
Injection

ROA

Intravenous; Intramuscular; Subcutaneous

Applicant Name

Roche Products Limited

NRN

A6-0106

Status

Active


ATC Code

B03XA03  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1 X 0.3ml  

Product Description

5 RNW-BV-230341 Mircera 75mcg METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA 75 µg/0.3 ml Active substance: methoxy polyethylene glycol-epoetin beta (produced by recombinant DNA technology in Chinese hamster ovary [CHO] cells) Excipients: L-Methionine, sodium sulphate anhydrous, sodium dihydrogen phosphate monohydrate, mannitol, Poloxamer 188, hydrochloric acid, sodium hydroxide (pH adjustment), water for injection (pH adjustment). A6-0106 Vaccines & Biologicals Biologics Imported Products 1*0.3ml 2/16/2022 ROCHE PRODUCTS LIMITED, 2nd Floor, 48/50 Isaac John Street Ikeja GRA, Lagos. 8056292219 angela.essien@roche.com Roche Diagnostics GmbH, Mannheim Sandhofer Strasse 116 D-68305 Mannheim, Germany, Roche Diagnostics GmbH, Mannheim Sandhofer Strasse 116 D-68305 Mannheim, Germany, Germany

Manufacturer Name

Roche Diagnostics GmbH, Mannheim Sandhofer Strasse 116 D-68305 Mannheim

Manufacturer Country

GERMANY  

Approval Date

2023-07-03  

Expiry Date

2028-07-02