MIRCERA Solution for injection Ref.[9292] Active ingredients: Epoetin beta

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Product name and form

MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe.
MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe.
MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe.
MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe.
MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe.
MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe.
MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe.
MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe.
MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe.
MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe.
MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe.

Pharmaceutical Form

Solution for injection in pre-filled syringe (injection).

The solution is clear and colourless to slightly yellowish.

Qualitative and quantitative composition

MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 100 micrograms/ml.

MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 133 micrograms/ml.

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.

MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 200 micrograms/ml.

MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 250 micrograms/ml.

MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 333 micrograms/ml.

MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 400 micrograms/ml.

MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 500 micrograms/ml.

MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 667 micrograms/ml.

MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 833 micrograms/ml.

MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe: One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 600 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. For more information, see section 5.1.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Epoetin beta

Epoetin beta stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the bone marrow. Epoetin beta is a continuous erythropoietin receptor activator that shows a different activity at the receptor level characterized by a slower association to and faster dissociation from the receptor, a reduced specific activity in vitro with an increased activity in vivo, as well as an increased half-life, in contrast to erythropoietin.

List of Excipients

Sodium dihydrogen phosphate monohydrate
Sodium sulphate
Mannitol (E421)
Methionine
Poloxamer 188
Water for injections

Pack sizes and marketing

Pre-filled syringe (type I glass) with laminated plunger stopper (bromobutyl rubber) and tip cap (bromobutyl rubber) and a needle 27G1/2.

Prefilled syringes 30, 40, 50, 60, 75, 100, 120, 150, 200 and 250 micrograms contain 0.3 ml solution.

Pre-filled syringe 360 micrograms contains 0.6 ml solution.

Prefilled syringes 30, 50, 75 micrograms are available in pack size of 1 or 3 pre-filled syringe(s).

Prefilled syringes 40, 60, 100, 120, 150, 200, 250 and 360 micrograms are available in pack size of 1 pre-filled syringe.

Not all pack sizes may be marketed.

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany

Marketing authorization dates and numbers

EU/1/07/400/008
EU/1/07/400/009
EU/1/07/400/010
EU/1/07/400/011
EU/1/07/400/012
EU/1/07/400/013
EU/1/07/400/017
EU/1/07/400/018
EU/1/07/400/019
EU/1/07/400/020
EU/1/07/400/021
EU/1/07/400/022
EU/1/07/400/023
EU/1/07/400/024

Date of first authorisation: 20 July 2007

Date of latest renewal: 15 May 2012

Drugs

Drug Countries
MIRCERA Austria, Australia, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States

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