PARMODIA Film-coated tablet Ref.[51004] Active ingredients: Pemafibrate

Source: Health Sciences Authority (SG)  Revision Year: 2022  Publisher: Kowa Company, Ltd., 6-29, Nishiki 3-chome, Naka-ku, Nagoya, Aichi, JAPAN

Product name and form

PARMODIA film-coated tablets 0.1 mg.

Pharmaceutical Form

Film-coated tablet.

White round film-coated tablets debossed ‘Kowa 217’ on one face and a score line on the reverse.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each film-coated tablet contains 0.1 mg of pemafibrate.

For a full list of excipients see section 6.1.

Active Ingredient Description
Pemafibrate

Pemafibrate is a peroxisome proliferator-activated receptor alpha (PPARα) agonist and activates PPARα by binding to this receptor and regulates the target gene expression, leading to decreased plasma triglyceride (TG) concentration, decreased triglyceride-rich lipoprotein, decreased apolipoprotein (Apo) C-3, and increased HDL-cholesterol.

List of Excipients

Tablet core:

Lactose hydrate
Croscarmellose sodium
Microcrystalline cellulose
Hydroxypropylcellulose
Magnesium stearate

Film coating:

Hypromellose
Triethyl citrate
Light anhydrous silicic acid
Titanium oxide
Carnauba wax

Pack sizes and marketing

PVC/Aluminium blisters in an aluminium-laminated bag, in a carton of 100 tablets (10 blisters x 10 tablets).

Marketing authorization holder

Kowa Company, Ltd., 6-29, Nishiki 3-chome, Naka-ku, Nagoya, Aichi, JAPAN

Marketing authorization dates and numbers

SIN16492P

18 May 2022

Drugs

Drug Countries
PARMODIA Japan, Singapore

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