GRANUPAS Gastro-resistant granules Ref.[6504] Active ingredients: 4-Aminosalicylic acid

Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Eurocept International BV, Trapgans 5, 1244 RL Ankeveen, The Netherlands

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.

Active Ingredient	Description
4-Aminosalicylic acid	Aminosalicylic acid is bacteriostatic against Mycobacterium tuberculosis. It inhibits the onset of bacterial resistance to streptomycin and isoniazid.

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

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

Marketing authorization dates and numbers

EU/1/13/896/001

Date of first authorisation: 07 April 2014

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