Is Qtern 5 mg/10 mg Film-Coated Tablets approved by KKM / NPRA in Malaysia?

Yes, Qtern 5 mg/10 mg Film-Coated Tablets is officially registered with the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia under registration number MAL19016095ARZ with status "PRODUCT APPROVED".

What are the generic alternatives for Qtern 5 mg/10 mg Film-Coated Tablets in Malaysia?

There are 1 approved pharmaceutical formulations registered in Malaysia containing the same active ingredient (Saxagliptin Hydrochloride), which can be compared for cost and availability.

MAL19016095ARZPrescription (MAL-A)

Qtern 5 mg/10 mg Film-Coated Tablets

Q: What are the active ingredients of Qtern 5 mg/10 mg Film-Coated Tablets?

The active ingredients of Qtern 5 mg/10 mg Film-Coated Tablets as declared to NPRA are: SAXAGLIPTIN HYDROCHLORIDE 5.95 mg, Dapagliflozin Propanediol Monohydrate 12.30 mg.

Generic Molecule: Saxagliptin Hydrochloride

ACTIVE & APPROVEDValid till: 1 Feb 2029

NPRA Official Regulatory Summary

Qtern 5 mg/10 mg Film-Coated Tablets is a KKM-approved Prescription Medicine registered under MAL number MAL19016095ARZ by ASTRAZENECA SDN. BHD.. Its active ingredient is SAXAGLIPTIN HYDROCHLORIDE 5.95 mg, Dapagliflozin Propanediol Monohydrate 12.30 mg, manufactured by AstraZeneca Pharmaceuticals LP.

Holder (PRH)

ASTRAZENECA SDN. BHD.

Manufacturer

AstraZeneca Pharmaceuticals LP

First Registered

1 Feb 2024

Validity

1 Feb 2029

Prescription Required (Schedule Poison)

Need a valid doctor's prescription renewal in Malaysia?

Consult Online Doctor (Telehealth)

Active Ingredients & Strength Formulation

2 Components

Active Substance / Molecule	Declared Strength / Dosage	Generic Directory
SAXAGLIPTIN HYDROCHLORIDE	5.95 mg	Find Brands
Dapagliflozin Propanediol Monohydrate	12.30 mg	Find Brands

Dosage values indicate declared active concentration per unit dose as registered with NPRA Malaysia.

Sole Registered Brand Formulation

This product is currently the primary or innovator formulation registered in Malaysia under Saxagliptin Hydrochloride.

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 MAL19016095ARZ 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 Qtern 5 mg/10 mg Film-Coated Tablets approved by KKM / NPRA?

Yes. Qtern 5 mg/10 mg Film-Coated Tablets is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL19016095ARZ with current status PRODUCT APPROVED. Registration was filed by ASTRAZENECA SDN. BHD..

What are the active ingredients of Qtern 5 mg/10 mg Film-Coated Tablets?

The declared active therapeutic components are: SAXAGLIPTIN HYDROCHLORIDE 5.95 mg, Dapagliflozin Propanediol Monohydrate 12.30 mg. Always follow dosage recommendations prescribed by a certified doctor or licensed pharmacist.

What are the registered generic alternatives in Malaysia?

In Malaysia, there are 1 registered brand formulations containing identical active ingredients (Saxagliptin Hydrochloride). You can review them in the alternative brands section above or consult your community pharmacist for generic bioequivalent substitution.

Semakan status pendaftaran KKM / NPRA: Qtern 5 mg/10 mg Film-Coated Tablets (MAL19016095ARZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.