Suppliers and packages for biologic ingredient: c1 esterase inhibitor (recombinant)
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Suppliers and packages for biologic ingredient: c1 esterase inhibitor (recombinant)
| Applicant | Tradename | Biologic Ingredient | Dosage | BLA | NDA/ANDA | Supplier | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| Pharming Americas Bv | RUCONEST | c1 esterase inhibitor (recombinant) | For Injection | 125495 | BLA | Tjoapack Netherlands BV | 69913-350-01 | 1 VIAL, SINGLE-USE in 1 CARTON (69913-350-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE |
| Pharming Americas Bv | RUCONEST | c1 esterase inhibitor (recombinant) | For Injection | 125495 | BLA | Pharming Healthcare Inc. | 71274-350-02 | 1 VIAL, SINGLE-USE in 1 CARTON (71274-350-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (71274-350-01) |
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