MAL17065012ACRZPrescription (MAL-A)

Dexmedetomidine Kabi 0.1mg/mL Concentrate for Infusion

Generic Molecule: Dexmedetomidine Hydrochloride

ACTIVE & APPROVEDValid till: 6 Jun 2027
NPRA Official Regulatory Summary

Dexmedetomidine Kabi 0.1mg/mL Concentrate for Infusion is a KKM-approved Prescription Medicine registered under MAL number MAL17065012ACRZ by FRESENIUS KABI MALAYSIA SDN. BHD. Its active ingredient is DEXMEDETOMIDINE HYDROCHLORIDE 0.118mg/ml 0, manufactured by Gland Pharma Limited.

Holder (PRH)
FRESENIUS KABI MALAYSIA SDN. BHD
Manufacturer
Gland Pharma Limited
First Registered
6 Jun 2022
Validity
6 Jun 2027

Prescription Required (Schedule Poison)

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Active Ingredients & Strength Formulation

1 Component
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
DEXMEDETOMIDINE HYDROCHLORIDE0.118mg/ml 0Find 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 MAL17065012ACRZ 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 Dexmedetomidine Kabi 0.1mg/mL Concentrate for Infusion approved by KKM / NPRA?

Yes. Dexmedetomidine Kabi 0.1mg/mL Concentrate for Infusion is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL17065012ACRZ with current status PRODUCT APPROVED. Registration was filed by FRESENIUS KABI MALAYSIA SDN. BHD.

What are the active ingredients of Dexmedetomidine Kabi 0.1mg/mL Concentrate for Infusion?

The declared active therapeutic components are: DEXMEDETOMIDINE HYDROCHLORIDE 0.118mg/ml 0. 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: Dexmedetomidine Kabi 0.1mg/mL Concentrate for Infusion (MAL17065012ACRZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.