Hemlibra 30mg/1ml
Hemlibra 30mg/1ml is a medicine authorised by Swissmedic under authorisation number 66694. The authorisation holder is Roche Pharma (Schweiz) AG. The medicinal product code is Biotechnological medicines 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 06 November 2018 and the authorisation is valid without a time limit. ATC code B02BX06 places the medicine in the group Antihemorrhagics.
| Authorisation number | 66694 |
|---|---|
| Name | Hemlibra 30mg/1ml |
| Full name | Hemlibra 30mg/1ml, Injektionslösung |
| Authorisation holder | Roche Pharma (Schweiz) AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | B02BX06 |
| First authorisation | 06 November 2018 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Hemlibra 30mg/1ml, Injektionslösung | A | 06 November 2018 |
| 2 | Hemlibra 60mg/0.4ml, Injektionslösung | A | 06 November 2018 |
| 3 | Hemlibra 105mg/0.7ml, Injektionslösung | A | 06 November 2018 |
| 4 | Hemlibra 150mg/1ml, Injektionslösung | A | 06 November 2018 |
| 5 | Hemlibra 12mg/0.4ml, Injektionslösung | A | 04 November 2024 |
| 6 | Hemlibra 300mg/2ml, Injektionslösung | A | 04 November 2024 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 | Durchstechflasche(n) | B02BX06 | 06.01.1. | A |
| 2 | 1 | Durchstechflasche(n) | B02BX06 | 06.01.1. | A |
| 3 | 1 | Durchstechflasche(n) | B02BX06 | 06.01.1. | A |
| 4 | 1 | Durchstechflasche(n) | B02BX06 | 06.01.1. | A |
| 5 | 1 | Durchstechflasche(n) | B02BX06 | 06.01.1. | A |
| 6 | 1 | Durchstechflasche(n) | B02BX06 | 06.01.1. | A |
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Other medicines from this authorisation holder
Frequently asked questions
Is Hemlibra 30mg/1ml authorised in Switzerland?
Yes. Hemlibra 30mg/1ml is authorised by Swissmedic under authorisation number 66694, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Hemlibra 30mg/1ml have?
Hemlibra 30mg/1ml 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 Hemlibra 30mg/1ml?
The authorisation holder is Roche Pharma (Schweiz) 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.