Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-9788 |
| Trade Name | Dose Form | Strength | Identifier |
| Firazyr | Solution for injection | 10 mg/mL | |
| Sponsor | Application date | Registration situation | Classification |
| Takeda New Zealand Limited Level 10, 21 Queens Street Auckland 1010 | 15/6/2015 | Consent given Approval date: 26/11/2015 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| solution for injection | Active | |
| Icatibant 10 mg/mL ((as Icatibant Acetate)) | Bachem AG Hauptstrasse 144 Bubendorf 4416 SWITZERLAND | |
| Excipient | ||
| Glacial acetic acid | ||
| Sodium chloride | ||
| Sodium hydroxide | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | SGS Institut Fresenius Berlin GmbH & Co KG Tegeler Weg 33 Berlin 10589 GERMANY |
| SGS Institut Fresenius GmbH Im Maisel 14 Taunusstein D-65232 GERMANY | |
| Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 GERMANY | |
| Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 GERMANY | |
| Vetter Pharma-Fertigung GmbH & Co KG Schuetzenstrasse 87, 99-101 Ravensburg D-88212 GERMANY | |
| Manufacture of Final Dose Form | Vetter Pharma-Fertigung GmbH & Co KG Schuetzenstrasse 87, 99-101 Ravensburg D-88212 GERMANY |
| Packing | Vetter Pharma-Fertigung GmbH & Co KG Schuetzenstrasse 87, 99-101 Ravensburg D-88212 GERMANY |
| Secondary Packaging | DHL Supply Chain (Netherlands) BV Bijsterhuizen 3142 Wijchen 6604LV NETHERLANDS |
| Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 | |
| NZ Site of Product Release | DHL Supply Chain (New Zealand) Ltd 6 Manu Tapu Drive Mangere Auckland 2022 |
Packaging
| Package | Contents | Shelf Life |
| Syringe, glass, clear 3 ml , coated bromobutyl plunger, Luer-lock adapter and screw cap in blister; packed in carton | 1 dose units | 24 months from date of manufacture stored at or below 25°C. Do not freeze |
Indications
FIRAZYR is indicated for symptomatic treatment of acute attacks of hereditary angiooedema (HAE) in adults (with C1-esterase-inhibitor deficiency).
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 1/11/2023 | Changed Medicine Notification | Active ingredient manufacture - G5 | Granted 4/12/2023 | 10/11/2023 | |
| 15/6/2015 | New Higher-risk Medicine Application | Abridged new higher-risk medicine containing one or more new active substance | Granted 26/11/2015 | 26/6/2015 | Y |
