MAL18046009AZPrescription (MAL-A)

Tresiba FlexTouch 100 U/ml Solution for Injection

Generic Molecule: Insulin Degludec

ACTIVE & APPROVEDValid till: 3 Apr 2028
NPRA Official Regulatory Summary

Tresiba FlexTouch 100 U/ml Solution for Injection is a KKM-approved Prescription Medicine registered under MAL number MAL18046009AZ by NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.. Its active ingredient is Insulin Degludec 100 U/ml, manufactured by NOVO NORDISK A/S.

Holder (PRH)
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
Manufacturer
NOVO NORDISK A/S
First Registered
3 Apr 2023
Validity
3 Apr 2028

Prescription Required (Schedule Poison)

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Active Ingredients & Strength Formulation

1 Component
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
Insulin Degludec100 U/mlFind 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 MAL18046009AZ 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 Tresiba FlexTouch 100 U/ml Solution for Injection approved by KKM / NPRA?

Yes. Tresiba FlexTouch 100 U/ml Solution for Injection is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL18046009AZ with current status PRODUCT APPROVED. Registration was filed by NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD..

What are the active ingredients of Tresiba FlexTouch 100 U/ml Solution for Injection?

The declared active therapeutic components are: Insulin Degludec 100 U/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 3 registered brand formulations containing identical active ingredients (Insulin Degludec). You can review them in the alternative brands section above or consult your community pharmacist for generic bioequivalent substitution.

Semakan status pendaftaran KKM / NPRA: Tresiba FlexTouch 100 U/ml Solution for Injection (MAL18046009AZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.