Methoxy polyethylene glycol-epoetin beta

Overview

Methoxy polyethylene glycol-epoetin beta is a chemically synthesised Erythropoiesis Stimulating Agent (ESA) with a longer half-life than erythropoietin. ESA is used to increase synthesis of red blood cells to treat chronic kidney disease associated anemia.

Indication

For the treatment of patients with anaemia associated with chronic kidney disease. Not a substitute for RBC transfusion if immediate correction of anemia is required.

Associated Conditions

Anemia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects	2021/01/13	NCT04707768	Phase 3	Completed	Akebia Therapeutics
A Study of Efepoetin Alfa in Treating Anaemia Associated With Chronic Kidney Diseases Patient	2019/11/07	NCT04155125	Phase 3	Completed	PT Kalbe Genexine Biologics
Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.	2018/06/11	NCT03552393	Phase 2	Completed	Hoffmann-La Roche
An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)	2015/09/11	NCT02547454	N/A	Completed	Hoffmann-La Roche
An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice	2014/10/13	NCT02263833	N/A	Completed	Hoffmann-La Roche
An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis	2014/09/12	NCT02238080	N/A	Completed	Hoffmann-La Roche
Frequent Dosing of CERA Improves Nutrition and Inflammation in Hemodialysis Patients	2014/09/05	NCT02232113	Phase 4	Completed	Taipei Veterans General Hospital, Taiwan
Comparison Among Erythropoietin Stimulating Agents	2014/01/30	NCT02049346	Phase 4	Completed	Hamad Medical Corporation
Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)	2014/01/24	NCT02044653	Phase 2	Completed	Genexine, Inc.
Phase IV Study to Evaluate the Efficacy and Safety of Mircera in PD	2013/03/08	NCT01807481	Phase 4	UNKNOWN	Samsung Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Mircera	Vifor (International) Inc.	59353-404	INTRAVENOUS	150 ug in 0.3 mL	10/12/2023
Mircera	Vifor (International) Inc.	59353-406	INTRAVENOUS	250 ug in 0.3 mL	10/12/2023
Mircera	Vifor (International) Inc.	59353-403	INTRAVENOUS	100 ug in 0.3 mL	10/12/2023
Mircera	Vifor (International) Inc.	59353-408	INTRAVENOUS	360 ug in 0.6 mL	10/12/2023
Mircera	Vifor (International) Inc.	59353-407	INTRAVENOUS	120 ug in 0.3 mL	10/12/2023
Mircera	Vifor (International) Inc.	59353-401	INTRAVENOUS	50 ug in 0.3 mL	10/12/2023
Mircera	Vifor (International) Inc.	59353-402	INTRAVENOUS	75 ug in 0.3 mL	10/12/2023
Mircera	Vifor (International) Inc.	59353-405	INTRAVENOUS	200 ug in 0.3 mL	10/12/2023
Mircera	Vifor (International) Inc.	59353-400	INTRAVENOUS	30 ug in 0.3 mL	10/12/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Mircera	Roche Registration GmbH,Emil-Barell-Strasse 1,79639 Grenzach-Wyhlen,Germany	Authorised	7/20/2007

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Mircera Solution for Injection 75mcg/0.3ml (Pre-filled Syringe)	F. Hoffmann-La Roche AG	SIN13530P	INJECTION, SOLUTION	75 mcg/0.3ml	8/19/2008
Mircera Solution for Injection 100mcg/0.3ml (Pre-filled Syringe)	F. Hoffmann-La Roche AG	SIN13529P	INJECTION, SOLUTION	100mcg/0.3ml	8/19/2008
Mircera Solution for Injection 50mcg/0.3ml (Pre-filled Syringe)	F. Hoffmann-La Roche AG	SIN13535P	INJECTION, SOLUTION	50mcg/0.3ml	8/19/2008

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
MIRCERA INJ 50MCG/0.3ML (PRE-FILLED SYRINGE)	N/A	ROCHE HONG KONG LIMITED	N/A	N/A	3/25/2008
MIRCERA INJ 200MCG/0.3ML (PRE-FILLED SYRINGE)	N/A	ROCHE HONG KONG LIMITED	N/A	N/A	3/25/2008
MIRCERA INJ 100MCG/0.3ML (PRE-FILLED SYRINGE)	N/A	ROCHE HONG KONG LIMITED	N/A	N/A	3/25/2008
MIRCERA INJ 150MCG/0.3ML (PRE-FILLED SYRINGE)	N/A	ROCHE HONG KONG LIMITED	N/A	N/A	3/25/2008
MIRCERA INJ 75MCG/0.3ML (PRE-FILLED SYRINGE)	N/A	ROCHE HONG KONG LIMITED	N/A	N/A	3/25/2008

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
MIRCERA methoxy polyethylene glycol-epoetin beta 120 mcg solution for injection syringe	153807	Roche Products Pty Ltd	Medicine	A	7/28/2009
MIRCERA methoxy polyethylene glycol-epoetin beta 150 mcg solution for injection syringe	153802	Roche Products Pty Ltd	Medicine	A	7/28/2009
MIRCERA methoxy polyethylene glycol-epoetin beta 250 mcg solution for injection syringe	153808	Roche Products Pty Ltd	Medicine	A	7/28/2009
MIRCERA methoxy polyethylene glycol-epoetin beta 200 mcg solution for injection syringe	153805	Roche Products Pty Ltd	Medicine	A	7/28/2009
MIRCERA methoxy polyethylene glycol-epoetin beta 30 mcg solution for injection syringe	153810	Roche Products Pty Ltd	Medicine	A	7/28/2009
MIRCERA methoxy polyethylene glycol-epoetin beta 75 mcg solution for injection syringe	153801	Roche Products Pty Ltd	Medicine	A	7/28/2009
MIRCERA methoxy polyethylene glycol-epoetin beta 100 mcg solution for injection syringe	153806	Roche Products Pty Ltd	Medicine	A	7/28/2009
MIRCERA methoxy polyethylene glycol-epoetin beta 50 mcg solution for injection syringe	153813	Roche Products Pty Ltd	Medicine	A	7/28/2009
MIRCERA methoxy polyethylene glycol-epoetin beta 360 mcg solution for injection syringe	153804	Roche Products Pty Ltd	Medicine	A	7/28/2009

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MIRCERA	Hoffmann-La Roche Limited	02308002	Solution - Subcutaneous , Intravenous	100 MCG / ML	N/A
MIRCERA	Hoffmann-La Roche Limited	02308010	Solution - Subcutaneous , Intravenous	200 MCG / ML	N/A
MIRCERA	Hoffmann-La Roche Limited	02308126	Solution - Intravenous , Subcutaneous	200 MCG / 0.3 ML	N/A
MIRCERA	Hoffmann-La Roche Limited	02308053	Solution - Subcutaneous , Intravenous	1000 MCG / ML	N/A
MIRCERA	Hoffmann-La Roche Limited	02308150	Solution - Intravenous , Subcutaneous	600 MCG / 0.6 ML	N/A
MIRCERA	Hoffmann-La Roche Limited	02307995	Solution - Subcutaneous , Intravenous	50 MCG / ML	N/A
MIRCERA	Hoffmann-La Roche Limited	02308037	Solution - Intravenous , Subcutaneous	400 MCG / ML	N/A
MIRCERA	Hoffmann-La Roche Limited	02308061	Solution - Intravenous , Subcutaneous	50 MCG / 0.3 ML	N/A
MIRCERA	Hoffmann-La Roche Limited	02308118	Solution - Subcutaneous , Intravenous	150 MCG / 0.3 ML	N/A
MIRCERA	Hoffmann-La Roche Limited	02308142	Solution - Intravenous , Subcutaneous	400 MCG / 0.6 ML	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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