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HSA Approval

POMAGEN CAPSULES 2MG

Approval Number

SIN16984P

Drug Name

POMAGEN CAPSULES 2MG

Product Name

POMAGEN CAPSULES 2MG

Approval Date

April 12, 2024

Registrant

LOTUS INTERNATIONAL PTE. LTD.

Regulatory Information

Registrant

LOTUS INTERNATIONAL PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

CAPSULE

Route of Administration

ORAL

Medical Information

ATC Code

L04AX06

ATC Item Name

pomalidomide

Manufacturer Information

Pharmaceutical Manufacturer

LOTUS INTERNATIONAL PTE. LTD.

Manufacturers

Lotus Pharmaceutical Co., Ltd. Nantou Plant

Active Ingredients

Ingredient Name

Pomalidomide

Strength

2.0 mg

Drug MonographPomalidomide

Documents

Package Inserts

POMAGEN CAPSULES PI.pdf

Approved: April 12, 2024

Patient Information Leaflets

1.4.4 PIL dd 122022_Pomagen Capsules all strengths.docx

Approved: April 12, 2024

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POMAGEN CAPSULES 2MG - HSA Approval | MedPath