MAL24086031AZPrescription (MAL-A)

UNIDEX Dexmedetomidine Injection USP Concentrate for Infusion 100 mcg/ml

Generic Molecule: Dexmedetomidine Hydrochloride

ACTIVE & APPROVEDValid till: 1 Aug 2029
NPRA Official Regulatory Summary

UNIDEX Dexmedetomidine Injection USP Concentrate for Infusion 100 mcg/ml is a KKM-approved Prescription Medicine registered under MAL number MAL24086031AZ by UNIMED SDN. BHD.. Its active ingredient is DEXMEDETOMIDINE HYDROCHLORIDE 118 mcg/mL, manufactured by Gland Pharma Limited.

Holder (PRH)
UNIMED SDN. BHD.
Manufacturer
Gland Pharma Limited
First Registered
1 Aug 2024
Validity
1 Aug 2029

Prescription Required (Schedule Poison)

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Active Ingredients & Strength Formulation

1 Component
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
DEXMEDETOMIDINE HYDROCHLORIDE118 mcg/mLFind 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 MAL24086031AZ 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 UNIDEX Dexmedetomidine Injection USP Concentrate for Infusion 100 mcg/ml approved by KKM / NPRA?

Yes. UNIDEX Dexmedetomidine Injection USP Concentrate for Infusion 100 mcg/ml is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL24086031AZ with current status PRODUCT APPROVED. Registration was filed by UNIMED SDN. BHD..

What are the active ingredients of UNIDEX Dexmedetomidine Injection USP Concentrate for Infusion 100 mcg/ml?

The declared active therapeutic components are: DEXMEDETOMIDINE HYDROCHLORIDE 118 mcg/mL. 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: UNIDEX Dexmedetomidine Injection USP Concentrate for Infusion 100 mcg/ml (MAL24086031AZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.