№ lp_1_10089
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This document is a pharmaceutical submission for the listing of daratumumab (DLd) in the Australian PBS for the treatment of transplant-ineligible, newly diagnosed multiple myeloma, comparing its efficacy and safety with other treatment regimens.
Year: 2025
Region / City: Australia
Topic: Pharmaceutical submission for drug listing
Document Type: Pharmaceutical submission
Organization: Janssen-Cilag Pty Ltd
Author: Not specified
Target Audience: Healthcare professionals, regulatory authorities
Validity Period: Not specified
Approval Date: Not specified
Date of Changes: March 2025
Note: Context
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
DARATUMUMAB, Solution for I.V. infusion 100 mg in 5 mL vial, Solution for I.V. infusion 400 mg in 20 mL vial, Solution for S.C. injection 1,800 mg in 15 mL vial
Year: 2023
Region / City: Australia
Topic: Medical treatment, Oncology, Myeloma
Document Type: Medical Submission
Organization / Institution: Janssen-Cilag Pty Ltd
Author: Unknown
Target Audience: Healthcare professionals, regulatory bodies
Period of validity: Ongoing, until treatment approval
Approval Date: April 2020 (IV formulation), September 2020 (SC formulation)
Date of amendments: Various PBAC meeting dates (2017-2022)
Request for Authorization for DARZALEX FASPRO® Treatment
Note: Year
Document Type: Request for Authorization
Request for Authorization of DARZALEX® Treatment
Year: [Insert Year]
Region / City: [Insert City, State]
Topic: Medical Treatment Authorization
Document Type: Medical Request Letter
Organization / Institution: [Insert Organization Name]
Author: [Insert Physician Name]
Target Audience: Medical Director / Payer Organization
Period of Validity: [Insert Period, if applicable]
Approval Date: [Insert Date of Approval, if applicable]
Date of Changes: [Insert Date of Changes, if applicable]
Authorization request for treatment with DARZALEX FASPRO® for [Insert Member Name]
Year: [Insert Year]
Region / City: [Insert City, State]
Document Type: Medical authorization letter
Organization / Institution: [Insert Physician or Medical Practice Name]
Author: [Insert Physician Name]
Intended Audience: Medical Director / Payer representative
Patient Diagnosis: [Insert Diagnosis]
ICD Code: [Insert ICD]
Medication: DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)
Dosage: 1,800 mg daratumumab and 30,000 units hyaluronidase per 15 mL
Request Type: Standard / Expedited
Clinical History Included: Yes
Supporting Documentation: Prescribing Information, peer-reviewed articles, clinical guidelines
Request Purpose: Prior authorization for treatment
Submissions Date: [Insert Date]
IBRUTINIB, Capsule 140 mg, Tablet 280 mg, Tablet 420 mg, Imbruvica®, JANSSEN-CILAG PTY LTD
Year: 2023
Region / City: Australia
Theme: Medicine, Oncology
Document Type: Submission Report
Organization / Institution: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: JANSSEN-CILAG PTY LTD
Target Audience: Healthcare professionals, regulators
Period of Validity: Ongoing
Approval Date: 28 March 2023
Modification Date: December 2022
GUSELKUMAB, Solution for injection 100 mg in 1 mL pen device, Tremfya®, Janssen-Cilag Pty Ltd
Year: 2020
Region / City: Australia
Topic: Pharmaceutical Benefits Scheme (PBS) listing
Document Type: Committee Submission
Agency: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: Committee Secretariat
Target Audience: Healthcare professionals, PBAC members
Period of Effect: From May 13, 2020
Approval Date: May 13, 2020
Modification Date: Not specified
Golimumab, Injection 50 mg in 0.5 mL single use pre-filled syringe and injection 50 mg in 0.5 mL single use pre-filled pen, Simponi® and Simponi Smartject®, Janssen-Cilag Pty Ltd
Year: 2017
Region / City: Australia
Theme: Pharmaceutical application
Document type: Resubmission for Authority Required listing
Organ / Institution: PBAC
Author: Janssen-Cilag Pty Ltd
Target audience: Medical professionals, regulatory bodies
Validity period: Ongoing
Approval date: November 2017
Modification date: Not specified
Topics: DARATUMUMAB Darzalex Janssen-Cilag