NIZORAL

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Cyprus, Estonia, Finland, Germany, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Nigeria, Poland, Romania, Singapore, UK.

Active ingredients

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

1	Ketoconazole UNII R9400W927I - KETOCONAZOLE
	Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes.
	Read more about Ketoconazole

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
NIZORAL Shampoo	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
D01AC08	Ketoconazole	D Dermatologicals → D01 Antifungals for dermatological use → D01A Antifungals for topical use → D01AC Imidazole and triazole derivatives
Discover more medicines within D01AC08

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	1574W, 9024Y
BR	Câmara de Regulação do Mercado de Medicamentos	514502603161319
CA	Health Products and Food Branch	02182920
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	03265207, 03265213, 09289628, 09289640, 13889819, 13889825
EE	Ravimiamet	1018189, 1060940, 1060951, 1060984, 1821204, 1843736, 1850116
FI	Lääkealan turvallisuus- ja kehittämiskeskus	393957, 454689, 522237
GB	Medicines & Healthcare Products Regulatory Agency	27623, 27655, 27660, 377406, 381563, 80674
HK	Department of Health Drug Office	31551
IE	Health Products Regulatory Authority	46094, 76333, 76350
IL	מִשְׂרַד הַבְּרִיאוּת	1397, 2491
JP	医薬品医療機器総合機構	2655709N1053, 2655709Q1025
LT	Valstybinė vaistų kontrolės tarnyba	1013162, 1014156, 1063038, 1066508, 1070167, 1075377, 1075481, 1082478, 1083391, 1089259, 1091909, 1092604, 1093129, 1093130
MT	Medicines Authority	MA830/00401, MA830/00402, PI1438/07301A, PI521/08402A, PI908/06601A
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	209M83, 295M89, 94M83
NG	Registered Drug Product Database	04-1733, 04-1734
Switch country to Nigeria in order to find specific presentations of NIZORAL
NL	Z-Index G-Standaard	12811599
NL	Z-Index G-Standaard, PRK	23264
NZ	Medicines and Medical Devices Safety Authority	3393, 3394, 3395
PL	Rejestru Produktów Leczniczych	100047790, 100047808, 100260710, 100260761, 100264687, 100266812, 100292318, 100327459, 100353630, 100356892, 100363202, 100366264, 100368122, 100413905, 100451660
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W57514001, W57514002
SG	Health Sciences Authority	01117P, 04926P
US	FDA, National Drug Code	50458-680