Refixia 500 IE
Refixia 500 IE is a medicine authorised by Swissmedic under authorisation number 66216. The authorisation holder is Novo Nordisk Pharma 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 05 September 2017 and the authorisation is valid without a time limit. ATC code B02BD04 places the medicine in the group Antihemorrhagics.
| Authorisation number | 66216 |
|---|---|
| Name | Refixia 500 IE |
| Full name | Refixia 500 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung |
| Authorisation holder | Novo Nordisk Pharma AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | B · Prescription only |
| ATC code | B02BD04 |
| First authorisation | 05 September 2017 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Refixia 500 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 05 September 2017 |
| 2 | Refixia 1000 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 05 September 2017 |
| 3 | Refixia 2000 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 05 September 2017 |
| 4 | Refixia 3000 IE, Pulver und Lösungsmittel zur Herstellung einer Injektionslösung | B | 19 December 2023 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | (1 Durchstechflasche mit Pulver und 1 Fertigspritze mit Lösungsmittel) und Verabreichungsset | B02BD04 | 06.01.1. | B | |
| 2 | (1 Durchstechflasche mit Pulver und 1 Fertigspritze mit Lösungsmittel) und Verabreichungsset | B02BD04 | 06.01.1. | B | |
| 3 | (1 Durchstechflasche mit Pulver und 1 Fertigspritze mit Lösungsmittel) und Verabreichungsset | B02BD04 | 06.01.1. | B | |
| 4 | (1 Durchstechflasche mit Pulver und 1 Fertigspritze mit Lösungsmittel) und Verabreichungsset | B02BD04 | 06.01.1. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Refixia 500 IE authorised in Switzerland?
Yes. Refixia 500 IE is authorised by Swissmedic under authorisation number 66216, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Refixia 500 IE have?
Refixia 500 IE 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 Refixia 500 IE?
The authorisation holder is Novo Nordisk Pharma 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.