F. HOFFMANN-LA ROCHE LTD
Date updated: 2026-04-19
TOTAL PRODUCT APPROVED: 9
TOTAL CONDITIONAL REGISTRATION: 1
Overview
Product Registered
Categories
Type of Products
Analysis
Product Holder
| Product holder name | Product count |
|---|---|
| 10 |
Product count10
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1–1 of 1
Analysis
Product API
| Ingredient (API) name | Product count |
|---|---|
| 2 | |
| 1 | |
| 1 | |
| 1 | |
| 1 |
Product count2
Product count1
Product count1
Product count1
Product count1
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Listing
Registered Product
| Product name | Product Reg. no | Type | Product Holder | Manufacturer | Importer | Registration Status |
|---|---|---|---|---|---|---|
| ENSPRYNG 120 mg/1ml solution for injection in pre-filled syringe | MAL22046009ACRZ | BIOLOGICS | ROCHE (MALAYSIA) SDN. BHD. | F. HOFFMANN-LA ROCHE LTD | ROCHE (MALAYSIA) SDN. BHD. | PRODUCT APPROVED |
| POLIVY 140mg Powder For Concentrate For Solution For Infusion | MAL21036008ACRZ | BIOLOGICS | ROCHE (MALAYSIA) SDN. BHD. | F. HOFFMANN-LA ROCHE LTD | ROCHE (MALAYSIA) SDN. BHD. | PRODUCT APPROVED |
| AVASTIN INJECTION 25MG/ML | MAL20081788ARSZ | BIOLOGICS | ROCHE (MALAYSIA) SDN. BHD. | F. HOFFMANN-LA ROCHE LTD | ROCHE (MALAYSIA) SDN. BHD. | PRODUCT APPROVED |
| POLIVY 30mg Powder For Concentrate For Solution For Infusion | MAL23086029ARZ | BIOLOGICS | ROCHE (MALAYSIA) SDN. BHD. | F. HOFFMANN-LA ROCHE LTD | ROCHE (MALAYSIA) SDN. BHD. | PRODUCT APPROVED |
| ROCEPHIN VIAL 1G IV | MAL19871009ARZ | NEW CHEMICAL ENTITY | ROCHE (MALAYSIA) SDN. BHD. | F. HOFFMANN-LA ROCHE LTD | ROCHE (MALAYSIA) SDN. BHD. | PRODUCT APPROVED |
| Lunsumio 1mg/ml Concentrate for Solution for Infusion | MAL24096026ARZ | BIOLOGICS | ROCHE (MALAYSIA) SDN. BHD. | F. HOFFMANN-LA ROCHE LTD | ROCHE (MALAYSIA) SDN. BHD. | CONDITIONAL REGISTRATION |
| Mabthera Vials 10mg/ml Concentrate For Solution For Infusion | MAL20102000ARZ | BIOLOGICS | ROCHE (MALAYSIA) SDN. BHD. | F. HOFFMANN-LA ROCHE LTD | ROCHE (MALAYSIA) SDN. BHD. | PRODUCT APPROVED |
| GAZYVA 1000 MG/ 40 ML CONCENTRATE FOR SOLUTION FOR INFUSION | MAL15105037ARZ | BIOLOGICS | ROCHE (MALAYSIA) SDN. BHD. | F. HOFFMANN-LA ROCHE LTD | ROCHE (MALAYSIA) SDN. BHD. | PRODUCT APPROVED |
ENSPRYNG 120 mg/1ml solution for injection in pre-filled syringe
Product Reg. noMAL22046009ACRZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF. HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
POLIVY 140mg Powder For Concentrate For Solution For Infusion
Product Reg. noMAL21036008ACRZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF. HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
AVASTIN INJECTION 25MG/ML
Product Reg. noMAL20081788ARSZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF. HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
POLIVY 30mg Powder For Concentrate For Solution For Infusion
Product Reg. noMAL23086029ARZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF. HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
ROCEPHIN VIAL 1G IV
Product Reg. noMAL19871009ARZ
TypeNEW CHEMICAL ENTITY
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF. HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
Lunsumio 1mg/ml Concentrate for Solution for Infusion
Product Reg. noMAL24096026ARZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF. HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusCONDITIONAL REGISTRATION
Mabthera Vials 10mg/ml Concentrate For Solution For Infusion
Product Reg. noMAL20102000ARZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF. HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
GAZYVA 1000 MG/ 40 ML CONCENTRATE FOR SOLUTION FOR INFUSION
Product Reg. noMAL15105037ARZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF. HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
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