Isotretinoin SUN 10 mg soft capsules
- Licence status
- Active substances
- Isotretinoin
- Dosage Form
- Capsule, soft
- Licence number
- PA2050/007/001
- Licence holder
- Sun Pharmaceutical Industries Europe B.V.
Product documents
- Package Leaflet
- Summary of Product Characteristics
- Public Assessment Report
Licence information
- ATC code
- 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
- Educational materials, physicians and pharmacist checklists , patient reminder cards. Pregnancy prevention programme
- Marketing availability
- Not marketed
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 26/11/2021