Fulvestrant 250 mg/5 mL
Product Overview
| Generic Name | Fulvestrant 250 mg/5 mL |
| Brand Name(s) | Faslodex, Perjeta |
| Category | Endocrine |
| Form | PFS, sol. for intramuscular injection, 250 mg/5 mL |
| Strength | 250 mg per 5 mL (50 mg/mL) |
| Therapeutic Class | Estrogen receptor antagonist (selective) |
| ATC Code | L02BA03 |
Manufacturing & Regulatory
| Manufacturer | AstraZeneca (Faslodex); EVER Pharma (Fulvestrant) |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Not publicly disclosed |
| COFEPRIS | 010.000.5880.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
Logistics & Export
| MOQ | 10 Units |
| Shelf Life | 36 months |
| Storage | Store in cool, dry place (supplier); protect from light; refrigerate per label if recommended |
| Incoterms | EXW 30049049 |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Supplied per batch upon request |
| SDS-Safety Data Sheet (PDF) | Upon Request, not publicly posted |
| CTD Summary (PDF) | CTD proprietary; available under commercial agreement/license |
Special Notes
Fulvestrant 250 mg/5 mL IM injection is indicated for estrogen receptor–positive, locally advanced or metastatic breast cancer in postmenopausal women— either as monotherapy or combined with palbociclib in HR+/HER2– cases ([[SMPC]]