EMA — authorised 18 December 2007
- Marketing authorisation holder: Hospira UK Limited
- Status: approved
🇪🇺 Silapo in European Union
EMA authorised Silapo on 18 December 2007
Marketing authorisations
EMA — authorised 18 December 2007
- Application: EMEA/H/C/000760
- Marketing authorisation holder: Stada Arzneimittel AG
- Local brand name: Silapo
- Indication: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis. Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of tra
- Pathway: biosimilar
- Status: approved
Silapo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in European Union
Frequently asked questions
Is Silapo approved in European Union?
Yes. EMA authorised it on 18 December 2007; EMA authorised it on 18 December 2007.
Who is the marketing authorisation holder for Silapo in European Union?
Hospira UK Limited holds the EU marketing authorisation.