SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| KADCYLA 100 mg powder for concentrate for solution for infusion | 100 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 5476.00 | NCE · Prescription | ROCHE | Valid |
| KADCYLA 160 mg powder for concentrate for solution for infusion | 160 mg | Powder for concentrate for solution for infusion · Intravenous use | 1 Vial | SAR 8761.65 | NCE · Prescription | ROCHE | Valid |
Indications — CHI Daman Drug Formulary
BREAST CANCER HER-2 +VE; BREAST CANCER MET.HER-2 +VE
EMA European Union — centrally authorised medicines
Kadcyla Roche Registration GmbH · Authorised · authorised 15 Nov 2013 · ATC L01FD03
Therapeutic indication (EMA)
Early Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Metastatic Breast Cancer (MBC) Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: Received prior therapy for locally advanced or metastatic disease, or Developed disease recurrence during or within six months of completing adjuvant therapy.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| KADCYLA | 02412365 | 100 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | HOFFMANN-LA ROCHE LIMITED |
| KADCYLA | 02473224 | 160 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | HOFFMANN-LA ROCHE LIMITED |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.