Monofer 100 mg / 1 ml
Monofer 100 mg / 1 ml is a medicine authorised by Swissmedic under authorisation number 67001. The authorisation holder is Pierre Fabre Pharma SA. The medicinal product code is Synthetic 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 26 August 2019 and the authorisation is valid without a time limit. ATC code B03AC places the medicine in the group Antianemic preparations.
| Authorisation number | 67001 |
|---|---|
| Name | Monofer 100 mg / 1 ml |
| Full name | Monofer 100 mg / 1 ml, Lösung zur intravenösen Injektion/Infusion |
| Authorisation holder | Pierre Fabre Pharma SA |
| Medicinal product code | Synthetic medicines |
| Dispensing category | B · Prescription only |
| ATC code | B03AC |
| First authorisation | 26 August 2019 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Monofer 100 mg / 1 ml, Lösung zur intravenösen Injektion/Infusion | B | 26 August 2019 |
| 2 | Monofer 500 mg / 5 ml, Lösung zur intravenösen Injektion/Infusion | B | 26 August 2019 |
| 3 | Monofer 1000 mg / 10 ml, Lösung zur intravenösen Injektion/Infusion | B | 26 August 2019 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 5 x 1 ml | Flasche(n) | B03AC | 06.07.1. | B |
| 2 | 5 ml | Flasche(n) | B03AC | 06.07.1. | B |
| 3 | 5 x 5 ml | Flasche(n) | B03AC | 06.07.1. | B |
| 4 | 10 ml | Flasche(n) | B03AC | 06.07.1. | B |
| 5 | 2 x 10 ml | Flasche(n) | B03AC | 06.07.1. | B |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Monofer 100 mg / 1 ml authorised in Switzerland?
Yes. Monofer 100 mg / 1 ml is authorised by Swissmedic under authorisation number 67001, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Monofer 100 mg / 1 ml have?
Monofer 100 mg / 1 ml 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 Monofer 100 mg / 1 ml?
The authorisation holder is Pierre Fabre Pharma SA. 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.