GRANUPAS Gastro-resistant granules

Product name and form

GRANUPAS 4 g gastro-resistant granules.

Pharmaceutical Form

Gastro-resistant granules.

The granules are small off white/light brown coloured approximately 1.5 mm diameter.

Qualitative and quantitative composition

Each sachet contains 4 g of para-aminosalicylic acid.

For the full list of excipients, see section 6.1.

List of Excipients

Silica, colloidal hydrated
Dibutyl sebacate
Methacrylic acid – Ethyl acrylate copolymer (1:1) Dispersion 30 per cent
Cellulose, microcrystalline

Pack sizes and marketing

Sachets consisting of paper/low density polyethylene/aluminium foil/primer/low density polyethylene.

Pack size of 30 sachets. A calibrated measuring spoon is provided.

Marketing Authorization Holder
Authorization Dates

Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands

Date of first authorisation: 07 April 2014

Marketing authorization number: