GRANISETRON Film-coated tablet Ref.[8215] Active ingredients: Granisetron

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Generics [UK] Limited, T/A Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Product name and form

Granisetron 1 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White to off-white tablet embossed “GS” on one side and plain on the reverse.

Qualitative and quantitative composition

Each tablet contains 1 mg granisetron (as hydrochloride).

Excipient with known effect: Each tablet contains 55.78 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description

Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5HT3 receptors). Pharmacological studies have demonstrated that granisetron is effective against nausea and vomiting as a result of cytostatic therapy.

List of Excipients

Tablet core:

Lactose Monohydrate
Cellulose, Microcrystalline
Sodium Starch Glycolate (type A)
Magnesium Stearate

Film coat:

Titanium Dioxide (E171)
Macrogol 400
Polysorbate 80

Pack sizes and marketing

PVC/PVDC aluminium foil opaque blisters in a cardboard carton and HDPE bottle with PE cap containing 1,2,4,5,6,7,10,14,20,28,30,50,90,100,150,200,250 and 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Generics [UK] Limited, T/A Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Marketing authorization dates and numbers

PL 04569/0688


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