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Medicines
United States
Methoxy polyethylene glycolepoetin beta

FDA 2007

Methoxy polyethylene glycolepoetin beta

Mircera

100MCG/0.3ML InjectionUnited StatesMarketedAuthorised 14 Nov 2007

Open in the registerAsk Osler about it

On this page

In other countries
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

MirceraCanada · 75 MCG / 0.3 ML · Solution · Hoffmann-LA Roche LimitedSame brand
MirceraCanada · 150 MCG / 0.3 ML · Solution · Hoffmann-LA Roche LimitedSame brand
MirceraCanada · 200 MCG / 0.3 ML · Solution · Hoffmann-LA Roche LimitedSame brand
MIRCERA 100 microgramos/0,3 ml SOLUCION INYECTABLE EN JERINGA PRECARGADASpain · 100 µg · solución inyectable en jeringa precargada · Roche Registration GmbhSame brand
MIRCERA 100 microgramos/0,3 ml SOLUCION INYECTABLE EN JERINGA PRECARGADASpain · 100 µg · solución inyectable en jeringa precargada · Roche Registration GmbhSame brand
MIRCERA 120 microgramos/0,3 ml SOLUCION INYECTABLE EN JERINGA PRECARGADASpain · 120 µg · solución inyectable en jeringa precargada · Roche Registration Gmbh

More with the same substance on this register

MirceraMethoxy polyethylene glycolepoetin beta · 0.6MG/KG · solutionUnited States
MirceraMethoxy polyethylene glycolepoetin beta · 150MCG/0.3ML · InjectionUnited States

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Same brand

🇪🇺MirceraEuropean Union · Roche Registration GmbHSame brand

🇭🇷MirceraCroatiaSame brand

🇮🇹MirceraItaly · Soluzione iniettabile · Roche Registration GMBHSame brand

🇳🇱Mircera 100 µg / 0,3 ml, oplossing voor injectie (in voorgevulde spuit)Netherlands · Oplossing voor injectie · Roche Registration GmbHSame brand

🇳🇱Mircera 120 µg/0,3 ml, oplossing voor injectie (in voorgevulde spuit)Netherlands · Oplossing voor injectie · Roche Registration GmbHSame brand

🇳🇱Mircera 150 µg / 0,3 ml, oplossing voor injectie (in voorgevulde spuit)Netherlands · Oplossing voor injectie · Roche Registration GmbHSame brand

🇷🇴MIRCERA 100 micrograme/0,3mlRomania · 100µg/0,3ml · sol. inj. in seringa preumpluta · Roche Registration GMBHSame brand

🇷🇴MIRCERA 100mcg/0.3mlRomania · 100mcg/0.3ml · sol. inj. in seringa preumpluta · Roche Registration LTDSame brand

🇷🇴MIRCERA 150 micrograme/0,3mlRomania · 150µg/0,3ml · sol. inj. in seringa preumpluta · Roche Registration GMBHSame brand

🇷🇸Mircera®Serbia · 75mcg/0.3mL · rastvor za injekciju u napunjenom injekcionom špricu · Roche DOO BeogradSame brand

🇷🇸Mircera®Serbia · 30mcg/0.3mL · rastvor za injekciju u napunjenom injekcionom špricu · Roche DOO BeogradSame brand

🇷🇸Mircera®Serbia · 120mcg/0.3 mL · rastvor za injekciju u napunjenom injekcionom špricu · Roche DOO BeogradSame brand

🇸🇦Mircera 100MCG-0.3ML Soln. for InjSaudi Arabia · Roche DiagnosticsSame brand

🇸🇦Mircera 100MCG-0.3ML Soln. for InjSaudi Arabia · F. Hoffmann-La Roche Ltd.Same brand

🇸🇦Mircera 150MCG-0.3ML Soln. for InjSaudi Arabia · F. Hoffmann-La Roche Ltd.Same brand

🇸🇬Mircera Solution for Injection 100mcg/0.3ml (Pre-filled Syringe)Singapore · 100mcg/0.3ml · injection, solution · Roche Singapore Pte. LTD.Same brand

🇸🇬Mircera Solution for Injection 50mcg/0.3ml (Pre-filled Syringe)Singapore · 50mcg/0.3ml · injection, solution · Roche Singapore Pte. LTD.Same brand

🇸🇬Mircera Solution for Injection 75mcg/0.3ml (Pre-filled Syringe)Singapore · 75 mcg/0.3ml · injection, solution · Roche Singapore Pte. LTD.Same brand

Documents

The official texts, at the regulator.

Register entryFDA

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

U.S. Food and Drug Administration

FDA Purple Book, September 2026 release; acquired 2026-10-10T15:29:54.330165+00:00; exact source fields retained with source-key projections.

Licence: FDA-created structured factual administrative metadata; public-domain policy with third-party exceptions · Added 11 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Methoxy polyethylene glycolepoetin beta
Strength: 100MCG/0.3ML
Dosage form: Injection
Route: Intravenous, Subcutaneous
Register: United States (FDA)
Status: Marketed
Status in the register: Licensed / Rx
Authorised: 14 Nov 2007
Registration: BLA 125164
Marketing authorisation holder: Vifor (International) Inc.
Procedure: 351(a)
Supply: Rx

FDA

MirceraMethoxy polyethylene glycolepoetin beta · 120MCG/0.3ML · Injection🇺🇸United States

FDAMirceraMethoxy polyethylene glycolepoetin beta · 200MCG/0.3ML · Injection🇺🇸United States

FDAMirceraMethoxy polyethylene glycolepoetin beta · 250MCG/0.3ML · Injection🇺🇸United States

FDAMirceraMethoxy polyethylene glycolepoetin beta · 360MCG/0.6ML · Injection🇺🇸United States

FDAMirceraMethoxy polyethylene glycolepoetin beta · 50MCG/0.3ML · Injection🇺🇸United States

FDAMirceraMethoxy polyethylene glycolepoetin beta · 75MCG/0.3ML · Injection🇺🇸United States

FDAMirceraMethoxy polyethylene glycolepoetin beta · 600MCG/0.6ML · Injection🇺🇸United States

FDAMirceraMethoxy polyethylene glycolepoetin beta · 400MCG/ML · Injection🇺🇸United States

FDAMirceraMethoxy polyethylene glycolepoetin beta · 200MCG/ML · Injection🇺🇸United States

FDAMirceraMethoxy polyethylene glycolepoetin beta · 300MCG/ML · Injection🇺🇸United States