MAL25116028AZPrescription (MAL-A)

Smofkabiven Extra Nitrogen, Emulsion for Infusion

Generic Molecule: L-Alanine

ACTIVE & APPROVEDValid till: 3 Nov 2030
NPRA Official Regulatory Summary

Smofkabiven Extra Nitrogen, Emulsion for Infusion is a KKM-approved Prescription Medicine registered under MAL number MAL25116028AZ by FRESENIUS KABI MALAYSIA SDN. BHD. Its active ingredient is L-Alanine 9.2 mg/mL, L-Arginine 7.8 mg/mL, Glycine 7.2 mg/mL, L-Histidine 2 mg/mL, L-ISOLEUCINE 3.3 mg/mL, L-Leucine 4.8 mg/mL, L-Lysine Acetate 6.1 mg/mL, L-METHIONINE 2.8 mg/mL, L-phenylalanine 3.3 mg/mL, L-Proline 7.3 mg/mL, L-Serine . 4.3 mg/mL, Taurine 0.7 mg/mL, L-Threonine 2.9 mg/mL, L-Tryptophan 1.3 mg/mL, L-TYROSINE 0.3 mg/mL, L-Valine 4.1 mg/mL, CALCIUM CHLORIDE DIHYDRATE 0.3 mg/mL, SODIUM GLYCEROPHOSPHATE, HYDRATED q.s* mg/mL, MAGNESIUM SULFATE, HEPTAHYDRATE 1.3 mg/mL, Potassium Chloride. 2.3 mg/mL, Sodium Acetate trihydrate 2.7 mg/mL, Zinc Sulphate Heptahydrate 0.01 mg/mL, GLUCOSE MONOHYDRATE 93 mg/mL, Soya-bean oil, (refined) 8.7 mg/mL, MEDIUM CHAIN TRIGLYCERIDES 8.7 mg/mL, REFINED OLIVE OIL 7.2 mg/mL, FISH OIL 4.3 mg/mL, manufactured by FRESENIUS KABI AB.

Holder (PRH)
FRESENIUS KABI MALAYSIA SDN. BHD
Manufacturer
FRESENIUS KABI AB
First Registered
3 Nov 2025
Validity
3 Nov 2030

Prescription Required (Schedule Poison)

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Active Ingredients & Strength Formulation

30 Components
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
L-Alanine9.2 mg/mLFind Brands
L-Arginine7.8 mg/mLFind Brands
Glycine7.2 mg/mLFind Brands
L-Histidine2 mg/mLFind Brands
L-ISOLEUCINE3.3 mg/mLFind Brands
L-Leucine4.8 mg/mLFind Brands
L-Lysine Acetate6.1 mg/mLFind Brands
L-METHIONINE2.8 mg/mLFind Brands
L-phenylalanine3.3 mg/mLFind Brands
L-Proline7.3 mg/mLFind Brands
L-Serine .4.3 mg/mLFind Brands
Taurine0.7 mg/mLFind Brands
L-Threonine2.9 mg/mLFind Brands
L-Tryptophan1.3 mg/mLFind Brands
L-TYROSINE0.3 mg/mLFind Brands
L-Valine4.1 mg/mLFind Brands
CALCIUM CHLORIDE DIHYDRATE0.3 mg/mLFind Brands
SODIUM GLYCEROPHOSPHATEFormulation ProprietaryFind Brands
HYDRATEDq.s* mg/mLFind Brands
MAGNESIUM SULFATEFormulation ProprietaryFind Brands
HEPTAHYDRATE1.3 mg/mLFind Brands
Potassium Chloride.2.3 mg/mLFind Brands
Sodium Acetate trihydrate2.7 mg/mLFind Brands
Zinc Sulphate Heptahydrate0.01 mg/mLFind Brands
GLUCOSE MONOHYDRATE93 mg/mLFind Brands
Soya-bean oilFormulation ProprietaryFind Brands
(refined)8.7 mg/mLFind Brands
MEDIUM CHAIN TRIGLYCERIDES8.7 mg/mLFind Brands
REFINED OLIVE OIL7.2 mg/mLFind Brands
FISH OIL4.3 mg/mLFind Brands
Dosage values indicate declared active concentration per unit dose as registered with NPRA Malaysia.

Equivalent Registered Brands in Malaysia1 Available

Products sharing identical active ingredient formulation (L-Alanine) approved by NPRA.

View All 1 Brands

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 MAL25116028AZ 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 Smofkabiven Extra Nitrogen, Emulsion for Infusion approved by KKM / NPRA?

Yes. Smofkabiven Extra Nitrogen, Emulsion for Infusion is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL25116028AZ with current status PRODUCT APPROVED. Registration was filed by FRESENIUS KABI MALAYSIA SDN. BHD.

What are the active ingredients of Smofkabiven Extra Nitrogen, Emulsion for Infusion?

The declared active therapeutic components are: L-Alanine 9.2 mg/mL, L-Arginine 7.8 mg/mL, Glycine 7.2 mg/mL, L-Histidine 2 mg/mL, L-ISOLEUCINE 3.3 mg/mL, L-Leucine 4.8 mg/mL, L-Lysine Acetate 6.1 mg/mL, L-METHIONINE 2.8 mg/mL, L-phenylalanine 3.3 mg/mL, L-Proline 7.3 mg/mL, L-Serine . 4.3 mg/mL, Taurine 0.7 mg/mL, L-Threonine 2.9 mg/mL, L-Tryptophan 1.3 mg/mL, L-TYROSINE 0.3 mg/mL, L-Valine 4.1 mg/mL, CALCIUM CHLORIDE DIHYDRATE 0.3 mg/mL, SODIUM GLYCEROPHOSPHATE, HYDRATED q.s* mg/mL, MAGNESIUM SULFATE, HEPTAHYDRATE 1.3 mg/mL, Potassium Chloride. 2.3 mg/mL, Sodium Acetate trihydrate 2.7 mg/mL, Zinc Sulphate Heptahydrate 0.01 mg/mL, GLUCOSE MONOHYDRATE 93 mg/mL, Soya-bean oil, (refined) 8.7 mg/mL, MEDIUM CHAIN TRIGLYCERIDES 8.7 mg/mL, REFINED OLIVE OIL 7.2 mg/mL, FISH OIL 4.3 mg/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 2 registered brand formulations containing identical active ingredients (L-Alanine). You can review them in the alternative brands section above or consult your community pharmacist for generic bioequivalent substitution.

Semakan status pendaftaran KKM / NPRA: Smofkabiven Extra Nitrogen, Emulsion for Infusion (MAL25116028AZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.