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