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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 (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Site Last Modified

  • Last Modified: Wednesday 13 November 2024, 12:32:37.

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