ORATANE

This brand name is authorized in Australia, Hong Kong, New Zealand, Singapore, South Africa

Active ingredients

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

1 Isotretinoin UNII EH28UP18IF - ISOTRETINOIN

Isotretinoin is a stereoisomer of all-trans retinoic acid (tretinoin). The exact mechanism of action of isotretinoin has not yet been elucidated in detail, but it has been established that the improvement observed in the clinical picture of severe acne is associated with suppression of sebaceous gland activity and a histologically demonstrated reduction in the size of the sebaceous glands. Furthermore, a dermal anti-inflammatory effect of isotretinoin has been established. Read about Isotretinoin

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ORATANE Soft capsule	Medicines and Medical Devices Safety Authority (NZ)	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
D10BA01	Isotretinoin	D Dermatologicals → D10 Anti-acne preparations → D10B Anti-acne preparations for systemic use → D10BA Retinoids for treatment of acne
Discover more medicines within D10BA01

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11716P, 11921K, 2549E, 2591J, 2592K
Country: HK	Department of Health Drug Office	Identifier(s): 50196, 50197, 61048
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 11854, 12448, 15407, 8213, 8986
Country: SG	Health Sciences Authority	Identifier(s): 11781P, 11782P, 14628P
Country: ZA	Health Products Regulatory Authority	Identifier(s): 35/13.4.2/0375, 35/13.4.2/0376, 42/13.4.2/0460