Roaccutan 10 mg
Roaccutan 10 mg is a medicine authorised by Swissmedic under authorisation number 45307. The authorisation holder is Cheplapharm Schweiz GmbH. 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 June 1983 and the authorisation is valid without a time limit. ATC code D10BA01 places the medicine in the group Anti-acne preparations.
| Authorisation number | 45307 |
|---|---|
| Name | Roaccutan 10 mg |
| Full name | Roaccutan 10 mg, Kapseln |
| Authorisation holder | Cheplapharm Schweiz GmbH |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | D10BA01 |
| First authorisation | 15 June 1983 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 3 | Roaccutan 10 mg, Kapseln | A | 15 June 1983 |
| 4 | Roaccutan 20 mg, Kapseln | A | 15 June 1983 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 34 | 30 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 42 | 30 | 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 Roaccutan 10 mg authorised in Switzerland?
Yes. Roaccutan 10 mg is authorised by Swissmedic under authorisation number 45307, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Roaccutan 10 mg have?
Roaccutan 10 mg 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 Roaccutan 10 mg?
The authorisation holder is Cheplapharm Schweiz GmbH. 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.