Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10110
Trade NameDose FormStrengthIdentifier
DarzalexConcentrate for infusion100 mg/5mL
SponsorApplication dateRegistration situationClassification
Janssen-Cilag (New Zealand) Ltd
P O Box 62185
Sylvia Park
Auckland 1644
9/2/2017Consent given
Approval date: 30/11/2017
Prescription
 

Composition

ComponentIngredientManufacturer
concentrate for infusionActive 
 Daratumumab 20 mg/mLJanssen 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 stepManufacturer
Finished Product TestingCilag 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 FormCilag AG
Hochstrasse 201
Schaffhausen CH-8200
Switzerland
 Vetter Pharma-Fertigung GmbH & Co KG
Mooswiesen 2
Ravensburg D-88214
Germany
Secondary PackagingCilag 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 ReleaseJanssen-Cilag (New Zealand) Ltd
507 Mt Wellington Highway
AUCKLAND 1060

Packaging

PackageContentsShelf Life
Vial, glass, 5 mL24 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 DateApplication TypeChange(s)StatusPayment DatePriority
23/4/2020Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified7/5/2020 
9/2/2017New Higher-risk Medicine ApplicationNew higher-risk medicine containing one or more new active substancesGranted 30/11/201715/2/2017Y
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