Is Suboxone Film 8mg/2mg approved by KKM / NPRA in Malaysia?

Yes, Suboxone Film 8mg/2mg is officially registered with the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia under registration number MAL23026006ACRSZ with status "PRODUCT APPROVED".

What are the generic alternatives for Suboxone Film 8mg/2mg in Malaysia?

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

MAL23026006ACRSZPrescription (MAL-A)

Suboxone Film 8mg/2mg

Q: What are the active ingredients of Suboxone Film 8mg/2mg?

The active ingredients of Suboxone Film 8mg/2mg as declared to NPRA are: NALOXONE HYDROCHLORIDE 2.44 mg, BUPRENORPHINE HYDROCHLORIDE 8.64 mg.

Generic Molecule: Naloxone Hydrochloride

ACTIVE & APPROVEDValid till: 2 Feb 2028

NPRA Official Regulatory Summary

Suboxone Film 8mg/2mg is a KKM-approved Prescription Medicine registered under MAL number MAL23026006ACRSZ by ZUELLIG PHARMA SDN. BHD.. Its active ingredient is NALOXONE HYDROCHLORIDE 2.44 mg, BUPRENORPHINE HYDROCHLORIDE 8.64 mg, manufactured by Aquestive Therapeutics Inc.

Holder (PRH)

ZUELLIG PHARMA SDN. BHD.

Manufacturer

Aquestive Therapeutics Inc

First Registered

2 Feb 2023

Validity

2 Feb 2028

Prescription Required (Schedule Poison)

Need a valid doctor's prescription renewal in Malaysia?

Consult Online Doctor (Telehealth)

Active Ingredients & Strength Formulation

2 Components

Active Substance / Molecule	Declared Strength / Dosage	Generic Directory
NALOXONE HYDROCHLORIDE	2.44 mg	Find Brands
BUPRENORPHINE HYDROCHLORIDE	8.64 mg	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 Naloxone Hydrochloride.

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 MAL23026006ACRSZ 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 Suboxone Film 8mg/2mg approved by KKM / NPRA?

Yes. Suboxone Film 8mg/2mg is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL23026006ACRSZ with current status PRODUCT APPROVED. Registration was filed by ZUELLIG PHARMA SDN. BHD..

What are the active ingredients of Suboxone Film 8mg/2mg?

The declared active therapeutic components are: NALOXONE HYDROCHLORIDE 2.44 mg, BUPRENORPHINE HYDROCHLORIDE 8.64 mg. 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 (Naloxone 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: Suboxone Film 8mg/2mg (MAL23026006ACRSZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.