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HSA Approval

AMLESSA TABLETS 8 mg/ 5mg

Approval Number

SIN15727P

Drug Name

AMLESSA TABLETS 8 mg/ 5mg

Product Name

AMLESSA TABLETS 8 mg/ 5mg

Approval Date

June 27, 2019

Registrant

SINGAPORE PHARMACEUTICAL PRIVATE LIMITED

Licence Holder

SINGAPORE PHARMACEUTICAL PRIVATE LIMITED

Regulatory Information

Registrant

SINGAPORE PHARMACEUTICAL PRIVATE LIMITED

Licence Holder

SINGAPORE PHARMACEUTICAL PRIVATE LIMITED

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

TABLET

Route of Administration

ORAL

Medical Information

ATC Code

C09BB04

ATC Item Name

perindopril and amlodipine

Manufacturer Information

Pharmaceutical Manufacturer

SINGAPORE PHARMACEUTICAL PRIVATE LIMITED

Manufacturers

Krka, d.d., Novo mesto

Active Ingredients

Ingredient Name

Perindopril 6.68 mg eqv. to Perindopril tert-Butylamine

Strength

8.000mg

Drug MonographPerindopril

Ingredient Name

Amlodipine besilate 6.935 mg eqv. to amlodipine

Strength

5.000mg

Drug MonographAmlodipine

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