Xigduo XR 5 mg / 500 mg
Xigduo XR 5 mg / 500 mg is a medicine authorised by Swissmedic under authorisation number 65377. 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 16 July 2015 and the authorisation is valid without a time limit. ATC code A10BD15 places the medicine in the group Drugs used in diabetes.
| Authorisation number | 65377 |
|---|---|
| Name | Xigduo XR 5 mg / 500 mg |
| Full name | Xigduo XR 5 mg / 500 mg, Filmtabletten |
| Authorisation holder | AstraZeneca AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | A10BD15 |
| First authorisation | 16 July 2015 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Xigduo XR 5 mg / 500 mg, Filmtabletten | B | 16 July 2015 |
| 2 | Xigduo XR 10 mg / 500 mg, Filmtabletten | B | 16 July 2015 |
| 3 | Xigduo XR 5 mg / 1000 mg, Filmtabletten | B | 16 July 2015 |
| 4 | Xigduo XR 10 mg / 1000 mg, Filmtabletten | B | 16 July 2015 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 28 | Tablette(n) | A10BD15 | 07.06.2. | B |
| 2 | 98 | Tablette(n) | A10BD15 | 07.06.2. | B |
| 3 | 28 | Tablette(n) | A10BD15 | 07.06.2. | B |
| 4 | 98 | Tablette(n) | A10BD15 | 07.06.2. | B |
| 5 | 28 | Tablette(n) | A10BD15 | 07.06.2. | B |
| 6 | 98 | Tablette(n) | A10BD15 | 07.06.2. | B |
| 7 | 28 | Tablette(n) | A10BD15 | 07.06.2. | B |
| 8 | 98 | Tablette(n) | A10BD15 | 07.06.2. | B |
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Other medicines from this authorisation holder
Frequently asked questions
Is Xigduo XR 5 mg / 500 mg authorised in Switzerland?
Yes. Xigduo XR 5 mg / 500 mg is authorised by Swissmedic under authorisation number 65377, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Xigduo XR 5 mg / 500 mg have?
Xigduo 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 Xigduo 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.