PERJETA (pertuzumab 420mg)
| Product Overview | |
| Generic Name | PERJETA (pertuzumab 420mg) |
| Brand Name(s) | Perjeta |
| Form | Vial, Lyophilized for IV infusion |
| Strength | 420 mg/14 mL vial (30 mg/mL) |
| Therapeutic Class | HER2 dimerization inhibitor (recombinant humanized IgG1 monoclonal antibody) |
| ATC Code | L01XC13 |
| Manufacturing & Regulatory | |
| Manufacturer | Genentech, Roche |
| Country | Switzerland, USA, |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | Clave: 010.000.6024.00 |
| Free Sale Certificate | Parallel Trade Approval |
| Logistics & Export | |
| MOQ | 4 Vials |
| Shelf Life | 24 Months |
| Storage | Refrigerate at 2 °C to 8 °C |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Only on wholesale quantities |
| SDS | Available upon request from manufacturer/distributor |
| CTD Summary | Not publicly available as a CTD for an approved finished medicine |
Description
Brand Produuct: PERJETA (Pertuzumab) Indication: HER2-positive breast cancer; and also indicated in combination with trastuzumab and docetaxel, for: – First‑line treatment of HER2‑positive metastatic or locally recurrent unresectable breast cancer – Neoadjuvant and adjuvant treatment of HER2‑positive early breast cancer at high risk of recurrence
