FLUIBRON Syrup Ref.[44646] Active ingredients: Ambroxol

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Chiesi Hellas A.E.B.E., Geroulanou sq & 1, Renou Poggi str., 17455 Alimos, Greece

Product name and form

FLUIBRON 15 mg/5 ml syrup (0.3% w/v).

Pharmaceutical Form

Syrup.

Qualitative and quantitative composition

FLUIBRON 15 mg/5 ml syrup.

100 ml of syrup contain: ambroxol hydrochloride 0.300 g.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ambroxol

Ambroxol induces activation of the surfactant system by acting directly on the type II pneumocytes of the alveoles and the Clara cells in the region of the small airways. It promotes the formation and outward transfer of surface-active material in the alveolar and bronchial region of the foetal and adult lungs.

List of Excipients

Liquid non-crystallizing sorbitol, glycerol, citric acid monohydrate, benzoic acid, sucralose, raspberry natural flavour, purified water.

Pack sizes and marketing

Internal packaging: type III glass, amber-coloured bottle with childproof cap and measuring cap.

Outer packaging: printed thin cardboard box.

Marketing authorization holder

Chiesi Hellas A.E.B.E., Geroulanou sq & 1, Renou Poggi str., 17455 Alimos, Greece

Marketing authorization dates and numbers

12668

22-02-1990 / 29-04-2011

Drugs

Drug Countries
FLUIBRON Brazil, Cyprus, Turkey

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