TRANSISOFT Powder for oral solution in sachet Ref.[49893] Active ingredients: Macrogol

Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Laboratoires Mayoly Spindler, 6 avenue de leurope BP 51, 78401 CHATOU Cedex, France

Product name and form

Transisoft 8.5 g powder for oral solution in sachet.

Pharmaceutical Form
Powder for oral solution in sachet. White or almost white powder.

Qualitative and quantitative composition

Each sachet contains 8.5 g of macrogol 3350.

Active Ingredient	Description
Macrogol	High molecular weight (4000) macrogols are long linear polymers which retain water molecules by means of hydrogen bonds. When administered by the oral route, they lead to an increase in volume of intestinal fluids.

List of Excipients
None.

Pack sizes and marketing

Paper/Polyethylene, Low Density/Aluminum Foil/Polyethylene, Low Density unit-dose sachet.

Pack sizes of 14 or 28 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratoires Mayoly Spindler, 6 avenue de l’europe BP 51, 78401 CHATOU Cedex, France

Marketing authorization dates and numbers

PA1993/002/001

Date of first authorisation: 16^th September 2016
Date of last renewal: 22^nd June 2021

Drugs

Drug	Countries
TRANSISOFT	Ireland, United Kingdom

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