8 authorised products containing Isotretinoin, from the HPRA register.
| Medicine | Active substance | Licence holder | Status |
|---|---|---|---|
| Isotretinoin 10 mg soft capsules PA0711/312/002 |
Isotretinoin | Rowex Limited, | Marketed |
| Isotretinoin 20 mg soft capsules PA0711/312/003 |
Isotretinoin | Rowex Limited, | Marketed |
| Isotretinoin GAP 10 mg capsule, soft PA22735/002/001 |
Isotretinoin | Gap S.A. | Not marketed |
| Isotretinoin GAP 20 mg capsule, soft PA22735/002/002 |
Isotretinoin | Gap S.A. | Not marketed |
| Isotretinoin SUN 10 mg soft capsules PA2050/007/001 |
Isotretinoin | Sun Pharmaceutical Industries Europe B.V. | Not marketed |
| Isotretinoin SUN 20 mg soft capsules PA2050/007/002 |
Isotretinoin | Sun Pharmaceutical Industries Europe B.V. | Not marketed |
| Roaccutane 10 mg soft capsules PA25306/001/001 |
Isotretinoin | Cheplapharm Registration GmbH | Marketed |
| Roaccutane 20 mg soft capsules PA25306/001/002 |
Isotretinoin | Cheplapharm Registration GmbH | Marketed |
Priya Life Science (2026). Irish Medicines Database. Available at: https://priyalifescience.com/medicines (Accessed: 5 July 2026).
Data: Health Products Regulatory Authority (HPRA) open dataset (“Authorised or Transfer Pending Products”), licensed CC BY 4.0, refreshed daily. Regulatory information only — not medical advice.