Mircera 50 ug / 0.3 ml
Mircera 50 ug / 0.3 ml is a medicine authorised by Swissmedic under authorisation number 57860. 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 27 September 2007 and the authorisation is valid without a time limit. ATC code B03XA03 places the medicine in the group Antianemic preparations.
| Authorisation number | 57860 |
|---|---|
| Name | Mircera 50 ug / 0.3 ml |
| Full name | Mircera 50 ug / 0.3 ml, Injektionslösung in einer Fertigspritze |
| Authorisation holder | Roche Pharma (Schweiz) AG |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | B03XA03 |
| First authorisation | 27 September 2007 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Mircera 50 ug / 0.3 ml, Injektionslösung in einer Fertigspritze | A | 27 September 2007 |
| 2 | Mircera 75 ug / 0.3 ml, Injektionslösung in einer Fertigspritze | A | 27 September 2007 |
| 3 | Mircera 100 ug / 0.3 ml, Injektionslösung in einer Fertigspritze | A | 27 September 2007 |
| 4 | Mircera 150 ug / 0.3 ml, Injektionslösung in einer Fertigspritze | A | 27 September 2007 |
| 5 | Mircera 200 ug / 0.3 ml, Injektionslösung in einer Fertigspritze | A | 27 September 2007 |
| 6 | Mircera 250 ug / 0.3 ml, Injektionslösung in einer Fertigspritze | A | 27 September 2007 |
| 10 | Mircera 30 ug / 0.3 ml, Injektionslösung in einer Fertigspritze | A | 10 September 2008 |
| 13 | Mircera 120 ug / 0.3 ml, Injektionslösung in einer Fertigspritze | A | 10 September 2008 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 x 0.3 | ml | B03XA03 | 06.07.3. | A |
| 3 | 1 x 0.3 | ml | B03XA03 | 06.07.3. | A |
| 5 | 1 x 0.3 | ml | B03XA03 | 06.07.3. | A |
| 7 | 1 x 0.3 | ml | B03XA03 | 06.07.3. | A |
| 9 | 1 x 0.3 | ml | B03XA03 | 06.07.3. | A |
| 11 | 1 x 0.3 | ml | B03XA03 | 06.07.3. | A |
| 18 | 1 x 0.3 | ml | B03XA03 | 06.07.3. | A |
| 21 | 1 x 0.3 | ml | B03XA03 | 06.07.3. | A |
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Other medicines from this authorisation holder
Frequently asked questions
Is Mircera 50 ug / 0.3 ml authorised in Switzerland?
Yes. Mircera 50 ug / 0.3 ml is authorised by Swissmedic under authorisation number 57860, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Mircera 50 ug / 0.3 ml have?
Mircera 50 ug / 0.3 ml 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 Mircera 50 ug / 0.3 ml?
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.