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HSA Approval

POSACONAZOLE SANDOZ GASTRO-RESISTANT TABLETS 100MG

Approval Number

SIN15897P

Drug Name

POSACONAZOLE SANDOZ GASTRO-RESISTANT TABLETS 100MG

Product Name

POSACONAZOLE SANDOZ GASTRO-RESISTANT TABLETS 100MG

Approval Date

March 9, 2020

Registrant

NOVARTIS (SINGAPORE) PTE LTD

Licence Holder

SANDOZ SINGAPORE PTE. LTD.

Regulatory Information

Registrant

NOVARTIS (SINGAPORE) PTE LTD

Licence Holder

SANDOZ SINGAPORE PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

TABLET, DELAYED RELEASE

Route of Administration

ORAL

Medical Information

ATC Code

J02AC04

ATC Item Name

posaconazole

Manufacturer Information

Pharmaceutical Manufacturer

SANDOZ SINGAPORE PTE. LTD.

Manufacturers

Catalent Pharma Solutions LLC

Lek Pharmaceuticals d.d. (Primary and Secondary Packager)

Active Ingredients

Ingredient Name

Posaconazole

Strength

100.00 mg

Drug MonographPosaconazole

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