Kombiglyze XR 5 mg/ 500 mg
Kombiglyze XR 5 mg/ 500 mg is a medicine authorised by Swissmedic under authorisation number 62598. The authorisation holder is AstraZeneca AG. The medicinal product code is Synthetic medicines and the dispensing category is B: Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly. First authorisation was granted on 19 December 2012 and the authorisation is valid without a time limit. ATC code A10BD10 places the medicine in the group Drugs used in diabetes.
| Authorisation number | 62598 |
|---|---|
| Name | Kombiglyze XR 5 mg/ 500 mg |
| Full name | Kombiglyze XR 5 mg/ 500 mg , Filmtabletten |
| Authorisation holder | AstraZeneca AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | A10BD10 |
| First authorisation | 19 December 2012 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Kombiglyze XR 5 mg/ 500 mg , Filmtabletten | B | 19 December 2012 |
| 2 | Kombiglyze XR 5 mg/1000 mg , Filmtabletten | B | 19 December 2012 |
| 3 | Kombiglyze XR 2.5 mg/1000 mg , Filmtabletten | B | 19 December 2012 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 4 | 28 | Tablette(n) | A10BD10 | 07.06.2. | B |
| 5 | 98 | Tablette(n) | A10BD10 | 07.06.2. | B |
| 7 | 28 | Tablette(n) | A10BD10 | 07.06.2. | B |
| 8 | 98 | Tablette(n) | A10BD10 | 07.06.2. | B |
| 2 | 56 | Tablette(n) | A10BD10 | 07.06.2. | B |
| 3 | 196 | Tablette(n) | A10BD10 | 07.06.2. | B |
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Frequently asked questions
Is Kombiglyze XR 5 mg/ 500 mg authorised in Switzerland?
Yes. Kombiglyze XR 5 mg/ 500 mg is authorised by Swissmedic under authorisation number 62598, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Kombiglyze XR 5 mg/ 500 mg have?
Kombiglyze XR 5 mg/ 500 mg is in dispensing category B. Supplied only against a prescription which, at the prescriber's discretion, may be dispensed repeatedly.
Who is the authorisation holder of Kombiglyze XR 5 mg/ 500 mg?
The authorisation holder is AstraZeneca 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.