Wir informieren Sie hiermit über eine Aktualisierung der wichtigen Produktinformation vom 13. April 2023 und 29. August 2023 zu Simulect, Injektionspräparat 10 mg und 20 mg. Details entnehmen Sie bitte dem Informationsschreiben der Firma.
Update – Important information on Simulect preparation for injection 10 mg and 20 mg
08.01.2024
| Preparation | Simulect, injection preparation10 mg and 20 mg |
|---|---|
| Registration number | 54630 |
| Active ingredient | basiliximabum |
| Authorization holder | Novartis Pharma Schweiz AG |
13.04.2023
| Preparation | Simulect, injection preparation10 mg and 20 mg |
|---|---|
| Registration number | 54630 |
| Active ingredient | basiliximabum |
| Authorization holder | Novartis Pharma Schweiz AG |
The solvent (water for injections in ampoules) co-packed with Simulect, preparation for injection 10 mg and 20 mg, may contain particles (glass fragments) 20 – 800 µm in size. The included solvent should therefore not be used. The quality of the Simulect vials themselves is not affected.
Supplied customers have already been contacted by Novartis Pharma Switzerland AG in agreement with Swissmedic.
For more information, please refer to the company's information letter.
Company information letter