MAL24096022AZPrescription (MAL-A)

BREZTRI AEROSPHERE 160/7.2/5 MICROGRAMS/ACTUATION, PRESSURISED INHALATION, SUSPENSION

Generic Molecule: Budesonide

ACTIVE & APPROVEDValid till: 5 Sept 2029
NPRA Official Regulatory Summary

BREZTRI AEROSPHERE 160/7.2/5 MICROGRAMS/ACTUATION, PRESSURISED INHALATION, SUSPENSION is a KKM-approved Prescription Medicine registered under MAL number MAL24096022AZ by ASTRAZENECA SDN. BHD.. Its active ingredient is BUDESONIDE 160 mcg, GLYCOPYRRONIUM BROMIDE 9 mcg, FORMOTEROL FUMARATE DIHYDRATE 5 mcg, manufactured by ASTRAZENECA DUNKERQUE PRODUCTION (AZDP).

Holder (PRH)
ASTRAZENECA SDN. BHD.
Manufacturer
ASTRAZENECA DUNKERQUE PRODUCTION (AZDP)
First Registered
5 Sept 2024
Validity
5 Sept 2029

Prescription Required (Schedule Poison)

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Active Ingredients & Strength Formulation

3 Components
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
BUDESONIDE160 mcgFind Brands
GLYCOPYRRONIUM BROMIDE9 mcgFind Brands
FORMOTEROL FUMARATE DIHYDRATE5 mcgFind Brands
Dosage values indicate declared active concentration per unit dose as registered with NPRA Malaysia.

Malaysian KKM Security Hologram Verification

FarmaChecker & Meditag™

By Malaysian Ministry of Health (KKM) regulation, all genuine registered pharmaceuticals, health supplements (MAL-N), and traditional products (MAL-T) distributed in Malaysia must feature an official tamper-evident security hologram sticker on the physical packaging.

1. Visual Tilt Check

Tilt the box under light to view the micro-engraved KKM coat of arms and multi-layer iridescent security patterns.

2. Match MAL Number

Ensure the printed MAL code matches MAL24096022AZ exactly on label and box.

3. FarmaChecker Scan

Scan using the official FarmaChecker app on iOS / Android to authenticate serial token with NPRA servers.

If the packaging lacks a security hologram or fails the FarmaChecker scan, do not consume and report to Cawangan Penguatkuasaan Farmasi (CPF KKM).
Frequently Asked Questions & Verification Details

Is BREZTRI AEROSPHERE 160/7.2/5 MICROGRAMS/ACTUATION, PRESSURISED INHALATION, SUSPENSION approved by KKM / NPRA?

Yes. BREZTRI AEROSPHERE 160/7.2/5 MICROGRAMS/ACTUATION, PRESSURISED INHALATION, SUSPENSION is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL24096022AZ with current status PRODUCT APPROVED. Registration was filed by ASTRAZENECA SDN. BHD..

What are the active ingredients of BREZTRI AEROSPHERE 160/7.2/5 MICROGRAMS/ACTUATION, PRESSURISED INHALATION, SUSPENSION?

The declared active therapeutic components are: BUDESONIDE 160 mcg, GLYCOPYRRONIUM BROMIDE 9 mcg, FORMOTEROL FUMARATE DIHYDRATE 5 mcg. Always follow dosage recommendations prescribed by a certified doctor or licensed pharmacist.

What are the registered generic alternatives in Malaysia?

In Malaysia, there are 33 registered brand formulations containing identical active ingredients (Budesonide). You can review them in the alternative brands section above or consult your community pharmacist for generic bioequivalent substitution.

Semakan status pendaftaran KKM / NPRA: BREZTRI AEROSPHERE 160/7.2/5 MICROGRAMS/ACTUATION, PRESSURISED INHALATION, SUSPENSION (MAL24096022AZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.