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GRANUPAS Gastro-resistant granules (2019)

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
Hypromellose
Cellulose, microcrystalline
Talc

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:

EU/1/13/896/001