Oxycodone/Naloxone Mundipharma 10 mg/5 mg
Oxycodone/Naloxone Mundipharma 10 mg/5 mg is a medicine authorised by Swissmedic under authorisation number 69358. The authorisation holder is Mundipharma Regulatory GmbH. The medicinal product code is Synthetic medicines and the dispensing category is A+: Supplied only against a single-use prescription with additional Swissmedic conditions, for example narcotics or medicines with mandatory educational material. First authorisation was granted on 17 May 2023 and the authorisation is valid without a time limit. The export lists no ATC code for this medicine.
| Authorisation number | 69358 |
|---|---|
| Name | Oxycodone/Naloxone Mundipharma 10 mg/5 mg |
| Full name | Oxycodone/Naloxone Mundipharma 10 mg/5 mg, Retardtabletten |
| Authorisation holder | Mundipharma Regulatory GmbH |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A+ · Prescription with conditions |
| ATC code | not stated |
| First authorisation | 17 May 2023 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Oxycodone/Naloxone Mundipharma 10 mg/5 mg, Retardtabletten | A+ | 17 May 2023 |
| 2 | Oxycodone/Naloxone Mundipharma 20 mg/10 mg, Retardtabletten | A+ | 17 May 2023 |
| 3 | Oxycodone/Naloxone Mundipharma 5 mg/2.5 mg, Retardtabletten | A+ | 17 May 2023 |
| 4 | Oxycodone/Naloxone Mundipharma 40 mg/20 mg, Retardtabletten | A+ | 17 May 2023 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| The Swissmedic export lists no pack sizes for this medicine. | |||||
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Frequently asked questions
Is Oxycodone/Naloxone Mundipharma 10 mg/5 mg authorised in Switzerland?
Yes. Oxycodone/Naloxone Mundipharma 10 mg/5 mg is authorised by Swissmedic under authorisation number 69358, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Oxycodone/Naloxone Mundipharma 10 mg/5 mg have?
Oxycodone/Naloxone Mundipharma 10 mg/5 mg is in dispensing category A+. Supplied only against a single-use prescription with additional Swissmedic conditions, for example narcotics or medicines with mandatory educational material.
Who is the authorisation holder of Oxycodone/Naloxone Mundipharma 10 mg/5 mg?
The authorisation holder is Mundipharma Regulatory 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.