NEBIDO

This brand name is authorized in Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Singapore, South Africa, Turkey, UK.

Active ingredients

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

1	Testosterone UNII H16A5VCT9C - TESTOSTERONE UNDECANOATE
	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

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
NEBIDO Solution for injection	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

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	538912050015813
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	28914-06-09
EE	Ravimiamet	1169445
FI	Lääkealan turvallisuus- ja kehittämiskeskus	074894
FR	Base de données publique des médicaments	69033757
GB	Medicines & Healthcare Products Regulatory Agency	229746, 398376
HK	Department of Health Drug Office	62529
HR	Agencija za lijekove i medicinske proizvode	HR-H-728666888
IE	Health Products Regulatory Authority	35614
IL	מִשְׂרַד הַבְּרִיאוּת	7745
LT	Valstybinė vaistų kontrolės tarnyba	1004441, 1068509
MT	Medicines Authority	MA1520/00101, PI908/18701A
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	107M2011
NL	Z-Index G-Standaard	15998789
NL	Z-Index G-Standaard, PRK	114359
PL	Rejestru Produktów Leczniczych	100140867
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W63885001, W63885002
SG	Health Sciences Authority	13281P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699546770076
ZA	Health Products Regulatory Authority	A38/21.7/0641