ANDROGEL

This brand name is authorized in Nigeria. It is also authorized in Austria, Brazil, Canada, Croatia, Estonia, France, Hong Kong SAR China, Ireland, Israel, Netherlands, Romania, Singapore, South Africa, United States.

Active ingredients

The drug ANDROGEL contains one active pharmaceutical ingredient (API):

1	Testosterone UNII 3XMK78S47O - 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.
	Read more about Testosterone

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
C4-1623	Gel	Androgel 16.2 mg/g (Testosterone Gel) GEL 16.2 mg/g 88 g x 1's	Transparent or slightly opalescent, colourless gel. Nature and contents of container: Multidose container (comprised of a polypropylene canister with an LOPE-lined pouch) and a metered-dose pump containing 88 g gel and delivering a minimum of 60 doses	25/02/2021

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ANDROGEL 1% Gel	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
G03BA03	Testosterone	G Genito urinary system and sex hormones → G03 Sex hormones and modulators of the genital system → G03B Androgens → G03BA 3-oxoandrosten (4) derivatives
Discover more medicines within G03BA03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
BR	Câmara de Regulação do Mercado de Medicamentos	542214120000405, 542214120000505
CA	Health Products and Food Branch	02245345, 02245346, 02249499
EE	Ravimiamet	1195253
FR	Base de données publique des médicaments	64205548, 68097237
HK	Department of Health Drug Office	57973, 57974
HR	Agencija za lijekove i medicinske proizvode	HR-H-864783232
IL	מִשְׂרַד הַבְּרִיאוּת	4677
NG	Registered Drug Product Database	C4-1623
NL	Z-Index G-Standaard	14943581
NL	Z-Index G-Standaard, PRK	131865, 74225
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W62752001, W62752002, W62752003, W62752004
SG	Health Sciences Authority	13161P, 13162P
US	FDA, National Drug Code	0051-8425, 0051-8450, 0051-8462
ZA	Health Products Regulatory Authority	A40/21.7/0260