TESTAVAN Transdermal gel Ref.[27746] Active ingredients: Testosterone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS, UK

Product name and form

Testavan 20 mg/g Transdermal gel.

Pharmaceutical Form

Transdermal gel.

Homogenous, translucent to slightly opalescent gel.

Qualitative and quantitative composition

One gram of gel contains 20 mg testosterone. One pump actuation delivers 1.15 g (1.25 mL) of gel equivalent to 23 mg of testosterone.

Excipient with known effect: One gram of gel contains 0.2 g of 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

Ethanol (96%)
Water, purified
Propylene glycol (E1520)
Diethylene glycol monoethyl ether
Carbomer 980
Trolamine
Disodium edetate

Pack sizes and marketing

Testavan is supplied in a multidose container consisting of a metering pump with a laminate foil pouch in a bottle, and is provided with a cap applicator with a hygienic lid. The pump is composed of polypropylene, ethylene propylene diene monomer and stainless steel and the pouch is a polyethylene/polyethylene terephthalate/aluminium/polyethylene laminate encased in a rigid polypropylene bottle.

The product is available in packs of one multidose container. Each pump contains 85.5 g Testavan gel and is capable of dispensing 56 metered doses.

Marketing authorization holder

Ferring Pharmaceuticals Ltd, Drayton Hall, Church Road, West Drayton, UB7 7PS, UK

Marketing authorization dates and numbers

PL 03194/0127

15/02/2018

Drugs

Drug Countries
TESTAVAN Austria, Australia, Estonia, Finland, Lithuania, Poland, Romania, United Kingdom

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