Revised: 31 May 2019
Medicines
Medsafe Product Detail | ![]() ![]() | |
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File ref: TT50-10110 |
Trade Name | Dose Form | Strength | Identifier |
Darzalex | Concentrate for infusion | 100 mg/5mL | |
Sponsor | Application date | Registration situation | Classification |
Janssen-Cilag (New Zealand) Ltd P O Box 62185 Sylvia Park Auckland 1644 | 9/2/2017 | Consent given Approval date: 30/11/2017 | Prescription |
Composition
Component | Ingredient | Manufacturer |
concentrate for infusion | Active | |
Daratumumab 20 mg/mL | Samsung Biologics Co Ltd 300, Songdo bio-daero Yeonsu-gu Incheon 21987 South Korea | |
Janssen Sciences Ireland UC Barnahely Ringaskiddy County Cork Ireland | ||
Biogen Inc 5000 Davis Drive Research Triangle Park North Carolina 27709 United States of America | ||
Excipient | ||
Glacial acetic acid | ||
Mannitol | ||
Polysorbate 20 | ||
Sodium acetate trihydrate | ||
Sodium chloride | ||
Water for injection |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Cilag AG Hochstrasse 201 Schaffhausen CH-8200 Switzerland |
Janssen Biologics BV Einsteinweg 101 Leiden 2333 CB Netherlands | |
Janssen Biotech Inc 200 Great Valley Parkway Malvern Pennsylvania 19355 United States of America | |
Janssen Sciences Ireland UC Barnahely Ringaskiddy County Cork Ireland | |
PharmAssist Inc. 392 State Highway 8 South New Berlin New York 13843 United States of America | |
PPD Development Ireland Ltd Building C, Garrycastle Business & Technology Park Athlone Co. Westmeath Ireland | |
Vetter Pharma-Fertigung GmbH & Co KG Eisenbahnstrasse 2-4 Langenargen D-88085 Germany | |
Vetter Pharma-Fertigung GmbH & Co KG Helmut-Vetter-Str. 10 Ravensburg Baden Wurttemberg 88213 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 | Cilag AG Hochstrasse 201 Schaffhausen CH-8200 Switzerland |
Vetter Pharma-Fertigung GmbH & Co KG Mooswiesen 2 Ravensburg D-88214 Germany | |
Secondary Packaging | Cilag AG Hochstrasse 201 Schaffhausen CH-8200 Switzerland |
Contract Pharmaceutical Services of Australia Pty Ltd 5 Eden Park Drive North Ryde NSW 2113 Australia | |
DHL Supply Chain (Australia) Pty Limited 52 Huntingwood Drive Huntingwood NSW 2148 Australia | |
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 | |
NZ Site of Product Release | Janssen-Cilag (New Zealand) Ltd 507 Mt Wellington Highway AUCKLAND 1060 |
Packaging
Package | Contents | Shelf Life |
Vial, glass, | 5 mL | 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. followed by 15 hours (including infusion time) at room temperature (15 to 25 deg C) |
Indications
DARZALEX is indicated for the treatment of patients:
with newly diagnosed multiple myeloma:
- who are eligible for autologous stem cell transplant. For use in combination with:
- bortezomib, thalidomide, and dexamethasone.
- who are ineligible for autologous stem cell transplant. For use in combination with:
- bortezomib, melphalan and prednisone, or
- lenalidomide and dexamethasone
with multiple myeloma who have received:
- at least one prior therapy. For use in combination with:
- bortezomib and dexamethasone, or
- lenalidomide and dexamethasone.
- at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent
For use as:
- monotherapy
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
19/4/2023 | CMN 24(5) | Indications/dosage - G1; Contraindications, warnings and precautions - G1; Data sheet - G1; Administrative fee (CMN) | Granted 23/11/2023 | 2/5/2023 | |
9/2/2017 | New Higher-risk Medicine Application | New higher-risk medicine containing one or more new active substances | Granted 30/11/2017 | 15/2/2017 | Y |