Hemgenix 1x10 e13 gc/mL
Hemgenix 1x10 e13 gc/mL is a medicine authorised by Swissmedic under authorisation number 68780. The authorisation holder is CSL Behring AG. The medicinal product code is Transplant: gene therapy product 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 07 December 2023 and the authorisation is limited until 06 December 2028. ATC code B02BD16 places the medicine in the group Antihemorrhagics.
| Authorisation number | 68780 |
|---|---|
| Name | Hemgenix 1x10 e13 gc/mL |
| Full name | Hemgenix 1x10 e13 gc/mL, Konzentrat für Infusionslösung |
| Authorisation holder | CSL Behring AG |
| Medicinal product code | Transplant: gene therapy product |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | B02BD16 |
| First authorisation | 07 December 2023 |
| Authorisation validity | 06 December 2028 |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Hemgenix 1x10 e13 gc/mL, Konzentrat für Infusionslösung | A | 07 December 2023 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 - 12 | Durchstechflasche(n) | B02BD16 | 06.99.0. | A |
| 2 | 13 – 24 | Durchstechflasche(n) | B02BD16 | 06.99.0. | A |
| 3 | 25 – 36 | Durchstechflasche(n) | B02BD16 | 06.99.0. | A |
| 4 | 37 – 48 | Durchstechflasche(n) | B02BD16 | 06.99.0. | A |
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Frequently asked questions
Is Hemgenix 1x10 e13 gc/mL authorised in Switzerland?
Yes. Hemgenix 1x10 e13 gc/mL is authorised by Swissmedic under authorisation number 68780, data as of 01 September 2026. The authorisation is limited until 06 December 2028.
Which dispensing category does Hemgenix 1x10 e13 gc/mL have?
Hemgenix 1x10 e13 gc/mL 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 Hemgenix 1x10 e13 gc/mL?
The authorisation holder is CSL Behring 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.