NEBIDO

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

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 about Testosterone

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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