ROACCUTANE

This brand name is authorized in Australia, Estonia, France, Hong Kong, Croatia, Ireland, Lithuania, Romania, Singapore, United Kingdom, South Africa

Active ingredients

The drug ROACCUTANE 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
ROACCUTANE Capsule, soft	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
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): 11621P
Country: EE	Ravimiamet	Identifier(s): 1004364, 1112230, 1190315, 1190360, 1190595, 1190607, 1190629, 1190630, 1517644, 1517655, 1638075, 1638086, 1638097, 1638109, 1638110, 1638121, 1638132, 1638143
Country: FR	Base de données publique des médicaments	Identifier(s): 66296030
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 152468, 90993
Country: HK	Department of Health Drug Office	Identifier(s): 20965, 20966
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-462694255
Country: IE	Health Products Regulatory Authority	Identifier(s): 44935, 44975
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1020558, 1020559, 1020560, 1020561, 1020562, 1020563, 1020564, 1022655, 1085789, 1091306, 1091307
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W03829001
Country: SG	Health Sciences Authority	Identifier(s): 04920P, 04921P
Country: ZA	Health Products Regulatory Authority	Identifier(s): R/13.4.2/118, R/13.4.2/119