Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
Roaccutane 10 mg soft capsules.
| Pharmaceutical Form |
|---|
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Capsules, soft. 10 mg capsules: Oval, opaque, brown-red capsules imprinted with ROA 10 in black ink. |
Each soft capsule contains 10 mg of isotretinoin.
Excipients with known effect:
Contains soya-bean oil (refined, hydrogenated and partially hydrogenated) and sorbitol.
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
| List of Excipients |
|---|
|
Capsule filling: Beeswax, yellow Capsule shell: Gelatin Dry printing ink: Shellac, modified |
Duplex (PVC/PVDC) aluminium blister packs containing 20, 30, 50 or 100 capsules.
Not all pack sizes may be marketed.
Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
PL 00031/0617
Date of first Authorisation, 22 September 2004, Date of last common renewal, 20 July 2009
| Drug | Countries | |
|---|---|---|
| ROACCUTANE | Australia, Estonia, France, Hong Kong, Croatia, Ireland, Lithuania, Romania, Singapore, United Kingdom, South Africa |
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