Part I, Section A: Product Particulars

A1 : Active Ingredient


A1.1 Active Ingredient Name

A1.2 Salt Form

A1.3 Strength of Active Ingredient (Quantity unit/ dose)

A1.4 Strength Salt-Free

A1.5 Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine or Others/ Plant/ Others)

A1.6 Form of Substance

A1.7 Remarks (if any)

A1.8 Status 

A2 : Excipients
A3 : Dosage
A4 : Product Description
A5 : Pharmacodynamic
A6 : Pharmacokinetics
A7 : Indication
A8 : Recommended Dose
A9 : Route of Administration
A10 : Contraindication
A11 : Warning and Precautions
A12 : Interaction with Other Medicaments
A13 : Pregnancy and Lactation
A14 : Side Effects
A15 : Symptoms & Treatment of Overdose
A16 : Effect on Ability to Drive and Use Machine
A17 : Preclinical Safety Data
A19 : Storage Condition
A18 : Instructions For Use
A20 : Shelf life
A21 : Therapeutical Code/ATC Code (If any)

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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