ROACCUTANE

This brand name is authorized in Australia, Croatia, Estonia, France, Hong Kong SAR China, Ireland, Lithuania, Romania, Singapore, South Africa, UK.

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 more about Isotretinoin

Medication package inserts

Below package inserts are available for further reading:

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