Roaccutane 20 mg soft capsules
- Licence status
- Withdrawn: 26/08/2021
- Active substances
- Isotretinoin
- Dosage Form
- Capsule, soft
- Licence number
- PPA1463/105/001
- Licence holder
- IMED Healthcare Ltd.
Product documents
- Package Leaflet
- Summary of Product Characteristics
- Public Assessment Report
Licence information
- ATC code
- D10BA Retinoids for treatment of acne, D10BA01 isotretinoin
- Legal supply status
- Product subject to prescription which may not be renewed (A)
- Place of sale
- Supply through pharmacies only
- Conditions of Licence
- This authorisation permits the holder to parallel-distribute product marketed in Ireland under the product authorisation number PA2307/007/002.
- Marketing availability
- Unknown
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 01/04/2016