Is PRECEDEX approved by KKM / NPRA in Malaysia?

Yes, PRECEDEX is officially registered with the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia under registration number MAL20014305ACRZ with status "PRODUCT APPROVED".

What are the generic alternatives for PRECEDEX in Malaysia?

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

MAL20014305ACRZPrescription (MAL-A)

PRECEDEX

Q: What are the active ingredients of PRECEDEX?

The active ingredients of PRECEDEX as declared to NPRA are: DEXMEDETOMIDINE HYDROCHLORIDE 118UG/ML.

Generic Molecule: Dexmedetomidine HCl 100 mcg/ml Injection

ACTIVE & APPROVEDValid till: 23 Sept 2026

NPRA Official Regulatory Summary

PRECEDEX is a KKM-approved Prescription Medicine registered under MAL number MAL20014305ACRZ by PFIZER (MALAYSIA) SDN. BHD.. Its active ingredient is DEXMEDETOMIDINE HYDROCHLORIDE 118UG/ML, manufactured by HOSPIRA INC..

Holder (PRH)

PFIZER (MALAYSIA) SDN. BHD.

Manufacturer

HOSPIRA INC.

First Registered

23 Sept 2021

Validity

23 Sept 2026

Prescription Required (Schedule Poison)

Need a valid doctor's prescription renewal in Malaysia?

Consult Online Doctor (Telehealth)

Active Ingredients & Strength Formulation

1 Component

Active Substance / Molecule	Declared Strength / Dosage	Generic Directory
DEXMEDETOMIDINE HYDROCHLORIDE	118UG/ML	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 Dexmedetomidine Hcl.

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 MAL20014305ACRZ 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 PRECEDEX approved by KKM / NPRA?

Yes. PRECEDEX is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL20014305ACRZ with current status PRODUCT APPROVED. Registration was filed by PFIZER (MALAYSIA) SDN. BHD..

What are the active ingredients of PRECEDEX?

The declared active therapeutic components are: DEXMEDETOMIDINE HYDROCHLORIDE 118UG/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 1 registered brand formulations containing identical active ingredients (Dexmedetomidine Hcl). You can review them in the alternative brands section above or consult your community pharmacist for generic bioequivalent substitution.

Semakan status pendaftaran KKM / NPRA: PRECEDEX (MAL20014305ACRZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.