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Therapeutic Pertuzumab antibody from the original Perjeta® commercial drug.
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ProductBatch | Antigen | Molecular Class | Drug Brand | Product Concentration | CoA | Quantity per vial | Storage Temperature | Expiry Date | Price from | |
|---|---|---|---|---|---|---|---|---|---|---|
HER2 |
Monoclonal Antibody |
Perjeta® |
30 mg/mL |
yes |
6 mg |
-80°C |
11/2020 |
419,40 € |
| Drug name | Perjeta® |
| INN | Pertuzumab |
| API type | Pertuzumab is a humanised IgG1 monoclonal antibody produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology. |
| Pharmacotherapeutic group | Antineoplastic agents, monoclonal antibodies |
| ATC code | L01XC13 |
| Target of antibody | HER2 |
| General function | Pertuzumab is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. |
| Short description | |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | 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), and thereby, blocks ligand-dependent heterodimerisation of HER2 with other HER family members, including EGFR, HER3 and HER4. As a result, 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. In addition, pertuzumab mediates antibody-dependent cell-mediated cytotoxicity (ADCC). |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | |
| Original license holder | Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany |
| Marketing authorisation numbers | EU/1/13/813/001 |
| Marketing authorisation holder | Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany |
| Name of the manufacturer of the biological active substance | Genentech, Inc. 1000 New Horizons Way Vacaville, CA 95688-9431 USA |
| Name and address of the manufacturer(s) responsible for batch release | Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Whylen Germany |
| Max shelf life | 24 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Glacial acetic acid L-Histidine Sucrose Polysorbate 20 Water for injections |
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