SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| MIRCERA 100MCG-0.3ML SOLN. FOR INJ | 100 µg | Solution for injection · Intravenous use | 1 Vial | SAR 800.00 | Biological · Prescription | SPIMACO ADDWAEIH | Valid |
| MIRCERA 150MCG-0.3ML SOLN. FOR INJ | 150 µg | Solution for injection · Intravenous use | 1 Vial | SAR 1201.00 | Biological · Prescription | SPIMACO ADDWAEIH | Valid |
| MIRCERA 200MCG-0.3ML SOLN. FOR INJ | 200 µg | Solution for injection · Intravenous use | 1 Vial | SAR 1602.00 | Biological · Prescription | SPIMACO ADDWAEIH | Valid |
| MIRCERA 50MCG-0.3ML SOLN. FOR INJ | 50 µg | Solution for injection · Intravenous use | 1 Vial | SAR 400.00 | Biological · Prescription | SPIMACO ADDWAEIH | Valid |
| MIRCERA 75MCG-0.3ML SOLN. FOR INJ | 75 µg | Solution for injection · Intravenous use | 1 Vial | SAR 600.00 | Biological · Prescription | SPIMACO ADDWAEIH | Valid |
Indications — CHI Daman Drug Formulary
CHRONIC KIDNEY DISEASE ASSOCIATED ANEMIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| MIRCERA | 0.6MG/KG | solution · injection | HOFFMAN-LA ROCHE | Prescription | 14 Nov 2007 |
EMA European Union — centrally authorised medicines
Mircera Roche Registration GmbH · Authorised · authorised 20 Jul 2007 · ATC B03XA03
Therapeutic indication (EMA)
Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients (see section 5.1). Treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in paediatric patients from 3 months to less than 18 years of age who are converting from another erythropoiesis stimulating agent (ESA) after their haemoglobin level was stabilised with the previous ESA (see section 5.1).
WHO WHO Model List of Essential Medicines (2025)
- 10.1. Antianaemia medicines · complementary
Therapeutic equivalent to erythropoiesis-stimulating agents for Anaemia due to chronic disease
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.