Isotretinoin Sandoz 5mg
Isotretinoin Sandoz 5mg is a medicine authorised by Swissmedic under authorisation number 68109. The authorisation holder is Sandoz Pharmaceuticals AG. The medicinal product code is Synthetic medicines and the dispensing category is A: Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly. First authorisation was granted on 15 November 2021 and the authorisation is valid without a time limit. ATC code D10BA01 places the medicine in the group Anti-acne preparations.
| Authorisation number | 68109 |
|---|---|
| Name | Isotretinoin Sandoz 5mg |
| Full name | Isotretinoin Sandoz 5mg, Weichkapseln |
| Authorisation holder | Sandoz Pharmaceuticals AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | D10BA01 |
| First authorisation | 15 November 2021 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Isotretinoin Sandoz 5mg, Weichkapseln | A | 15 November 2021 |
| 2 | Isotretinoin Sandoz 10mg, Weichkapseln | A | 15 November 2021 |
| 3 | Isotretinoin Sandoz 20mg, Weichkapseln | A | 15 November 2021 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 30 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 2 | 100 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 3 | 30 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 4 | 100 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 5 | 30 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 6 | 100 | Kapsel(n) | D10BA01 | 10.02.0. | A |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Isotretinoin Sandoz 5mg authorised in Switzerland?
Yes. Isotretinoin Sandoz 5mg is authorised by Swissmedic under authorisation number 68109, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Isotretinoin Sandoz 5mg have?
Isotretinoin Sandoz 5mg is in dispensing category A. Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly.
Who is the authorisation holder of Isotretinoin Sandoz 5mg?
The authorisation holder is Sandoz Pharmaceuticals AG. The holder carries the legal responsibility for quality, safety and product information of the medicine in Switzerland.
Sources
Swissmedic data as of 01 September 2026. No medical advice. Independent directory, not affiliated with Swissmedic or the FOPH.