MAL25056018AZPrescription (MAL-A)

DEXMAIN (Dexmedetomidine 100 mcg/mL Concentrated for Solution for Infusion)

Generic Molecule: Dexmedetomidine Hydrochloride

CONDITIONAL REGISTRATIONValid till: 22 May 2030
NPRA Official Regulatory Summary

DEXMAIN (Dexmedetomidine 100 mcg/mL Concentrated for Solution for Infusion) is a KKM-approved Prescription Medicine registered under MAL number MAL25056018AZ by AIN MEDICARE SDN. BHD.. Its active ingredient is DEXMEDETOMIDINE HYDROCHLORIDE 0.0118 %w/v, manufactured by AIN MEDICARE SDN. BHD..

Holder (PRH)
AIN MEDICARE SDN. BHD.
Manufacturer
AIN MEDICARE SDN. BHD.
First Registered
22 May 2025
Validity
22 May 2030

Prescription Required (Schedule Poison)

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Active Ingredients & Strength Formulation

1 Component
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
DEXMEDETOMIDINE HYDROCHLORIDE0.0118 %w/vFind 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 MAL25056018AZ 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 DEXMAIN (Dexmedetomidine 100 mcg/mL Concentrated for Solution for Infusion) approved by KKM / NPRA?

Yes. DEXMAIN (Dexmedetomidine 100 mcg/mL Concentrated for Solution for Infusion) is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL25056018AZ with current status CONDITIONAL REGISTRATION. Registration was filed by AIN MEDICARE SDN. BHD..

What are the active ingredients of DEXMAIN (Dexmedetomidine 100 mcg/mL Concentrated for Solution for Infusion)?

The declared active therapeutic components are: DEXMEDETOMIDINE HYDROCHLORIDE 0.0118 %w/v. Always follow dosage recommendations prescribed by a certified doctor or licensed pharmacist.

What are the registered generic alternatives in Malaysia?

In Malaysia, there are 9 registered brand formulations containing identical active ingredients (Dexmedetomidine 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: DEXMAIN (Dexmedetomidine 100 mcg/mL Concentrated for Solution for Infusion) (MAL25056018AZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.