Is Sisalon 50mg Tablet approved by KKM / NPRA in Malaysia?

Yes, Sisalon 50mg Tablet is officially registered with the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia under registration number MAL18116061AZ with status "PRODUCT APPROVED".

What are the generic alternatives for Sisalon 50mg Tablet in Malaysia?

There are 3 approved pharmaceutical formulations registered in Malaysia containing the same active ingredient (Sertraline Hydrochloride), which can be compared for cost and availability.

MAL18116061AZPrescription (MAL-A)

Sisalon 50mg Tablet

Q: What are the active ingredients of Sisalon 50mg Tablet?

The active ingredients of Sisalon 50mg Tablet as declared to NPRA are: SERTRALINE HYDROCHLORIDE 55.95mg 0.

Generic Molecule: Sertraline Hydrochloride

ACTIVE & APPROVEDValid till: 16 Nov 2028

NPRA Official Regulatory Summary

Sisalon 50mg Tablet is a KKM-approved Prescription Medicine registered under MAL number MAL18116061AZ by MEDISPEC (M) SDN. BHD.. Its active ingredient is SERTRALINE HYDROCHLORIDE 55.95mg 0, manufactured by UNISON LABORATORIES CO.LTD.

Holder (PRH)

MEDISPEC (M) SDN. BHD.

Manufacturer

UNISON LABORATORIES CO.LTD

First Registered

16 Nov 2023

Validity

16 Nov 2028

Prescription Required (Schedule Poison)

Need a valid doctor's prescription renewal in Malaysia?

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Active Ingredients & Strength Formulation

1 Component

Active Substance / Molecule	Declared Strength / Dosage	Generic Directory
SERTRALINE HYDROCHLORIDE	55.95mg 0	Find Brands

Dosage values indicate declared active concentration per unit dose as registered with NPRA Malaysia.

Equivalent Registered Brands in Malaysia2 Available

Products sharing identical active ingredient formulation (Sertraline Hydrochloride) approved by NPRA.

View All 2 Brands

Prescription (MAL-A)MAL17111019AZ

Inosert-50 (Sertraline Tablets 50 mg)

Strength: 55.95mg 0

Neshdwara Services

CONDITIONAL REGISTRATION

Prescription (MAL-A)MAL17111020AZ

Inosert-100 (Sertraline Tablets 100 mg)

Strength: 111.90mg 0

Neshdwara Services

CONDITIONAL REGISTRATION

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 MAL18116061AZ 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 Sisalon 50mg Tablet approved by KKM / NPRA?

Yes. Sisalon 50mg Tablet is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL18116061AZ with current status PRODUCT APPROVED. Registration was filed by MEDISPEC (M) SDN. BHD..

What are the active ingredients of Sisalon 50mg Tablet?

The declared active therapeutic components are: SERTRALINE HYDROCHLORIDE 55.95mg 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 3 registered brand formulations containing identical active ingredients (Sertraline 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: Sisalon 50mg Tablet (MAL18116061AZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.