Darzalex 100mg/5ml
Darzalex 100mg/5ml is a medicine authorised by Swissmedic under authorisation number 66072. The authorisation holder is Janssen-Cilag 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 December 2016 and the authorisation is valid without a time limit. ATC code L01FC01 places the medicine in the group Antineoplastic agents.
| Authorisation number | 66072 |
|---|---|
| Name | Darzalex 100mg/5ml |
| Full name | Darzalex 100mg/5ml, Konzentrat zur Herstellung einer Infusionslösung |
| Authorisation holder | Janssen-Cilag AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | L01FC01 |
| First authorisation | 06 December 2016 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 3 | Darzalex 100mg/5ml, Konzentrat zur Herstellung einer Infusionslösung | A | 27 January 2023 |
| 4 | Darzalex 400mg/20ml, Konzentrat zur Herstellung einer Infusionslösung | A | 27 January 2023 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 3 | 1 | Durchstechflasche(n) | L01FC01 | 07.16.1. | A |
| 4 | 1 | Durchstechflasche(n) | L01FC01 | 07.16.1. | A |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Darzalex 100mg/5ml authorised in Switzerland?
Yes. Darzalex 100mg/5ml is authorised by Swissmedic under authorisation number 66072, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Darzalex 100mg/5ml have?
Darzalex 100mg/5ml 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 Darzalex 100mg/5ml?
The authorisation holder is Janssen-Cilag 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.