MAL15065042AZPrescription (MAL-A)

BUPREN 8MG/2MG SUBLINGUAL TABLET

Generic Molecule: Buprenorphine Hydrochloride

CONDITIONAL REGISTRATIONValid till: 1 Jul 2027
NPRA Official Regulatory Summary

BUPREN 8MG/2MG SUBLINGUAL TABLET is a KKM-approved Prescription Medicine registered under MAL number MAL15065042AZ by PAHANG PHARMACY SDN. BHD.. Its active ingredient is BUPRENORPHINE HYDROCHLORIDE 8.640mg 0, NALOXONE HYDROCHLORIDE 2.447mg 0, manufactured by Noripharma Sdn. Bhd..

Holder (PRH)
PAHANG PHARMACY SDN. BHD.
Manufacturer
Noripharma Sdn. Bhd.
First Registered
1 Jul 2025
Validity
1 Jul 2027

Prescription Required (Schedule Poison)

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Active Ingredients & Strength Formulation

2 Components
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
BUPRENORPHINE HYDROCHLORIDE8.640mg 0Find Brands
NALOXONE HYDROCHLORIDE2.447mg 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 MAL15065042AZ 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 BUPREN 8MG/2MG SUBLINGUAL TABLET approved by KKM / NPRA?

Yes. BUPREN 8MG/2MG SUBLINGUAL TABLET is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL15065042AZ with current status CONDITIONAL REGISTRATION. Registration was filed by PAHANG PHARMACY SDN. BHD..

What are the active ingredients of BUPREN 8MG/2MG SUBLINGUAL TABLET?

The declared active therapeutic components are: BUPRENORPHINE HYDROCHLORIDE 8.640mg 0, NALOXONE HYDROCHLORIDE 2.447mg 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 6 registered brand formulations containing identical active ingredients (Buprenorphine 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: BUPREN 8MG/2MG SUBLINGUAL TABLET (MAL15065042AZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.