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HSA Approval

Frenolyn Powder for Oral Inhalation 200mcg/dose

Approval Number

SIN13870P

Drug Name

Frenolyn Powder for Oral Inhalation 200mcg/dose

Product Name

Frenolyn Powder for Oral Inhalation 200mcg/dose

Approval Date

October 4, 2010

Registrant

MEDOCHEMIE SINGAPORE PTE. LTD.

Licence Holder

MEDOCHEMIE SINGAPORE PTE. LTD.

Regulatory Information

Registrant

MEDOCHEMIE SINGAPORE PTE. LTD.

Licence Holder

MEDOCHEMIE SINGAPORE PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

POWDER, METERED

Route of Administration

RESPIRATORY (INHALATION)

Medical Information

ATC Code

R03BA02

ATC Item Name

budesonide

Manufacturer Information

Pharmaceutical Manufacturer

MEDOCHEMIE SINGAPORE PTE. LTD.

Manufacturers

Medochemie Ltd (FACTORY AV)

Active Ingredients

Ingredient Name

Budesonide micronised

Strength

200mcg/dose

Drug MonographBudesonide

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Frenolyn Powder for Oral Inhalation 200mcg/dose - HSA Approval | MedPath