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.

  • Dispensing category A
  • Authorisation number 68780
  • ATC B02BD16
  • Transplant: gene therapy product
Authorisation data
Authorisation number68780
NameHemgenix 1x10 e13 gc/mL
Full nameHemgenix 1x10 e13 gc/mL, Konzentrat für Infusionslösung
Authorisation holderCSL Behring AG
Medicinal product codeTransplant: gene therapy product
Dispensing categoryA · Prescription, not repeatable
ATC codeB02BD16
First authorisation07 December 2023
Authorisation validity06 December 2028
Strengths
No.NameDispensing categoryAuthorisation date
1Hemgenix 1x10 e13 gc/mL, Konzentrat für InfusionslösungA07 December 2023

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Pack sizes
Pack codeQuantityUnitATCIT codeDispensing category
11 - 12Durchstechflasche(n)B02BD1606.99.0.A
213 – 24Durchstechflasche(n)B02BD1606.99.0.A
325 – 36Durchstechflasche(n)B02BD1606.99.0.A
437 – 48Durchstechflasche(n)B02BD1606.99.0.A

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Other medicines from this authorisation holder

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.

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