TESTOGEL Gel Ref.[7122] Active ingredients: Testosterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Besins Healthcare (UK) Limited, 1st Floor, 28 Poland Street, London, W1F 8QN, United Kingdom

Product name and form

TESTOGEL 50 mg, gel in sachet.

Pharmaceutical Form

Gel in sachet.

Transparent or slightly opalescent, colourless gel in sachet.

Qualitative and quantitative composition

One sachet of 5 g contains 50 mg of testosterone.

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

Carbomer 980
Isopropyl myristate
Ethanol 96%
Sodium hydroxide
Purified water

Pack sizes and marketing

5 g in sachet (PET/Aluminium/LDPE).

Boxes of 1, 2, 7, 10, 14, 28, 30, 50, 60, 90 or 100 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder

Besins Healthcare (UK) Limited, 1st Floor, 28 Poland Street, London, W1F 8QN, United Kingdom

Marketing authorization dates and numbers

PL 42714/0002

04/11/2006

Drugs

Drug Countries
TESTOGEL Austria, Australia, Cyprus, Estonia, Spain, Finland, Hong Kong, Ireland, Malta, Turkey, United Kingdom

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