Elocta 250 I.E.
Elocta 250 I.E. is a medicine authorised by Swissmedic under authorisation number 65843. The authorisation holder is Swedish Orphan Biovitrum AG. The medicinal product code is Biotechnological 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 23 June 2016 and the authorisation is valid without a time limit. ATC code B02BD02 places the medicine in the group Antihemorrhagics.
| Authorisation number | 65843 |
|---|---|
| Name | Elocta 250 I.E. |
| Full name | Elocta 250 I.E., Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
| Authorisation holder | Swedish Orphan Biovitrum AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | B · Prescription only |
| ATC code | B02BD02 |
| First authorisation | 23 June 2016 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Elocta 250 I.E., Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 23 June 2016 |
| 2 | Elocta 500 I.E., Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 23 June 2016 |
| 4 | Elocta 1000 I.E., Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 23 June 2016 |
| 5 | Elocta 1500 I.E., Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 23 June 2016 |
| 6 | Elocta 2000 I.E., Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 23 June 2016 |
| 7 | Elocta 3000 I.E., Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 23 June 2016 |
| 8 | Elocta 4000 I.E., Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 22 November 2018 |
| 11 | Elocta 750 I.E., Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 17 December 2020 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 | Set | B02BD02 | 06.01.1. | B |
| 2 | 1 | Set | B02BD02 | 06.01.1. | B |
| 4 | 1 | Set | B02BD02 | 06.01.1. | B |
| 5 | 1 | Set | B02BD02 | 06.01.1. | B |
| 6 | 1 | Set | B02BD02 | 06.01.1. | B |
| 7 | 1 | Set | B02BD02 | 06.01.1. | B |
| 8 | 1 | Set | B02BD02 | 06.01.1. | B |
| 11 | 1 | Set | B02BD02 | 06.01.1. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Elocta 250 I.E. authorised in Switzerland?
Yes. Elocta 250 I.E. is authorised by Swissmedic under authorisation number 65843, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Elocta 250 I.E. have?
Elocta 250 I.E. 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 Elocta 250 I.E.?
The authorisation holder is Swedish Orphan Biovitrum 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.