TESTIM Transdermal Gel Ref.[7123] Active ingredients: Testosterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Endo Ventures Limited, First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, IRELAND

Product name and form

TESTIM 50 mg Transdermal Gel.

Pharmaceutical Form

Transdermal Gel.

A clear to translucent gel.

Qualitative and quantitative composition

One single dose container of 5g contains 50 mg testosterone.

Excipient with known effect: 5 g contains 0.25 g propylene glycol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Testosterone

Testosterone, secreted by the testes and its major metabolite dihydrotestosterone (DHT), is responsible for the development of the external and internal genital organs and for maintaining the secondary sexual characteristics (stimulating hair growth, deepening of the voice, development of the libido); for a general effect on protein anabolism; for development of skeletal muscle and body fat distribution; for a reduction in urinary nitrogen, sodium, potassium, chloride, phosphate and water excretion.

List of Excipients

Purified water
Pentadecalactone
Carbomer 980
Carbomer copolymer
Propylene glycol
Glycerol
Macrogol 1000
Ethanol
Trometamol

Pack sizes and marketing

TESTIM is supplied in unit dose aluminium tubes with epoxy phenolic liners and screw caps, each containing 5g gel. The tubes are packed in cartons containing 7, 14, 30 and 90 tubes.

Not all pack sizes may be marketed.

Marketing authorization holder

Endo Ventures Limited, First Floor, Minerva House, Simmonscourt Road, Ballsbridge, Dublin 4, IRELAND

Marketing authorization dates and numbers

PL 43808/0018

20/02/2009

Drugs

Drug Countries
TESTIM Canada, Estonia, Ireland, Lithuania, United Kingdom, United States

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