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ILAXTEN Tablets (2019)

Product Name and Form

Ilaxten 20 mg tablets.

Pharmaceutical form

Tablet.

Oval biconvex scored white tablets (length 10 mm, width 5 mm).

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and Quantitative Composition

Each tablet contains 20 mg of bilastine.

For the full list of excipients, see section 6.1.

List of excipients

Cellulose, microcrystalline
Sodium starch glycolate type A (derived from potato)
Silica, colloidal anhydrous
Magnesium stearate

Pack sizes and Marketing

The medicinal product is packaged in a blister, consisting of two parts:

  • Laminate, consisting of oriented polyamide (outer side of laminate), aluminium and PVC (inner side of laminate).
  • Aluminium foil.

The aluminium foil is thermosealed with a heat-seal lacquer (PVC-PVAC copolymer and resins of butylmethacrylate) to the laminate after molding and filling of the tablets.

Each blister contains 10 tablets. The blisters are packaged in cardboard boxes.

Pack sizes: 10, 20, 30, 40 or 50 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Date of first authorisation: 08/10/2010

Date of latest renewal: 08/09/2015

Marketing authorization number:

PL 16239/0034