Isotretinoin-Mepha 10 mg
Isotretinoin-Mepha 10 mg is a medicine authorised by Swissmedic under authorisation number 55972. The authorisation holder is Mepha Pharma 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 18 September 2002 and the authorisation is valid without a time limit. ATC code D10BA01 places the medicine in the group Anti-acne preparations.
| Authorisation number | 55972 |
|---|---|
| Name | Isotretinoin-Mepha 10 mg |
| Full name | Isotretinoin-Mepha 10 mg, Weichkapseln |
| Authorisation holder | Mepha Pharma AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | D10BA01 |
| First authorisation | 18 September 2002 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Isotretinoin-Mepha 10 mg, Weichkapseln | A | 18 September 2002 |
| 2 | Isotretinoin-Mepha 20 mg, Weichkapseln | A | 18 September 2002 |
| 3 | Isotretinoin-Mepha 40 mg, Weichkapseln | A | 12 April 2007 |
| 4 | Isotretinoin-Mepha 5mg, Weichkapseln | A | 21 March 2018 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 9 | 30 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 11 | 100 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 13 | 30 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 15 | 100 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 17 | 30 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 19 | 100 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 1 | 30 | Kapsel(n) | D10BA01 | 10.02.0. | A |
| 2 | 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-Mepha 10 mg authorised in Switzerland?
Yes. Isotretinoin-Mepha 10 mg is authorised by Swissmedic under authorisation number 55972, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Isotretinoin-Mepha 10 mg have?
Isotretinoin-Mepha 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 Isotretinoin-Mepha 10 mg?
The authorisation holder is Mepha Pharma 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.