SETOFILM Orodispersible film Ref.[27891] Active ingredients: Ondansetron

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Product name and form

Setofilm 4 mg Orodispersible Films.

Pharmaceutical Form

Orodispersible Film.

Setofilm 4 mg Orodispersible Film: White, rectangular (size 3 cm²), orodispersible film.

Qualitative and quantitative composition

Setofilm 4 mg Orodispersible Films:

Each film contains 4 mg of ondansetron (as base).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Ondansetron

Ondansetron is a potent, highly selective 5HT3 receptor-antagonist. Its precise mode of action in the control of nausea and vomiting is not known.

List of Excipients

Poly (vinyl alcohol)
Macrogol 1000
Acesulfame potassium E950
Glycerol E422
Titanium dioxide E171
Rice starch
Levomenthol
Polysorbate 80 E433

Pack sizes and marketing

The primary packaging material is a sachet, which will be opened and removed before application. The material is a composite foil composed of kraft paper (outer layer), LDPE, aluminium foil and Surlyn (inner layer).

Pack size of 2, 4, 6, 10, 30 and 50.

Not all pack sizes may be marketed.

Marketing authorization holder

Norgine Pharmaceuticals Limited, Norgine House, Widewater Place, Moorhall Road, Harefield, Uxbridge, UB9 6NS, UK

Marketing authorization dates and numbers

PL 20011/0041

11/05/2010

Drugs

Drug Countries
SETOFILM Spain, France, Italy, United Kingdom

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