MAL14095024AZPrescription (MAL-A)

Combiwave FB 200 (Formoterol Fumarate 6mcg/actuation and Budesonide 200mcg/actuation Pressurised Inhalation)

Generic Molecule: Budesonide

ACTIVE & APPROVEDValid till: 20 Sept 2029
NPRA Official Regulatory Summary

Combiwave FB 200 (Formoterol Fumarate 6mcg/actuation and Budesonide 200mcg/actuation Pressurised Inhalation) is a KKM-approved Prescription Medicine registered under MAL number MAL14095024AZ by Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.. Its active ingredient is BUDESONIDE 0.2mg, FORMOTEROL FUMARATE 0.00628mg 0, manufactured by GLENMARK PHARMACEUTICALS LTD.

Holder (PRH)
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
Manufacturer
GLENMARK PHARMACEUTICALS LTD
First Registered
20 Sept 2024
Validity
20 Sept 2029

Prescription Required (Schedule Poison)

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Active Ingredients & Strength Formulation

2 Components
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
BUDESONIDE0.2mgFind Brands
FORMOTEROL FUMARATE0.00628mg 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 MAL14095024AZ 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 Combiwave FB 200 (Formoterol Fumarate 6mcg/actuation and Budesonide 200mcg/actuation Pressurised Inhalation) approved by KKM / NPRA?

Yes. Combiwave FB 200 (Formoterol Fumarate 6mcg/actuation and Budesonide 200mcg/actuation Pressurised Inhalation) is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL14095024AZ with current status PRODUCT APPROVED. Registration was filed by Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd..

What are the active ingredients of Combiwave FB 200 (Formoterol Fumarate 6mcg/actuation and Budesonide 200mcg/actuation Pressurised Inhalation)?

The declared active therapeutic components are: BUDESONIDE 0.2mg, FORMOTEROL FUMARATE 0.00628mg 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 33 registered brand formulations containing identical active ingredients (Budesonide). You can review them in the alternative brands section above or consult your community pharmacist for generic bioequivalent substitution.

Semakan status pendaftaran KKM / NPRA: Combiwave FB 200 (Formoterol Fumarate 6mcg/actuation and Budesonide 200mcg/actuation Pressurised Inhalation) (MAL14095024AZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.