Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Perjeta 420 mg concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
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Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale yellow, liquid. |
One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml. After dilution, one ml of solution contains approximately 3.02 mg of pertuzumab for the initial dose and approximately 1.59 mg of pertuzumab for the maintenance dose (see section 6.6).
Pertuzumab is a humanised IgG1 monoclonal antibody produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pertuzumab |
Pertuzumab is a recombinant humanised monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab inhibits ligand-initiated intracellular signalling through two major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase (PI3K). Inhibition of these signalling pathways can result in cell growth arrest and apoptosis, respectively. |
| List of Excipients |
|---|
|
Glacial acetic acid |
Vial (Type I glass) with a stopper (butyl rubber) containing 14 ml of solution.
Pack of 1 vial.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
EU/1/13/813/001
Date of first authorisation: 4th March 2013
Date of latest renewal: 8th December 2017
| Drug | Countries | |
|---|---|---|
| PERJETA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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