EMA — authorised 26 May 2023
- Marketing authorisation holder: Fennec Pharmaceuticals (EU) Limited
- Status: approved
🇪🇺 Sodium Thiosulfate in European Union
EMA authorised Sodium Thiosulfate on 26 May 2023
Marketing authorisations
EMA — authorised 26 May 2023
- Application: EMEA/H/C/005130
- Marketing authorisation holder: Norgine B.V.
- Local brand name: Pedmarqsi
- Indication: Pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.
- Status: approved
Sodium Thiosulfate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Sodium Thiosulfate approved in European Union?
Yes. EMA authorised it on 26 May 2023; EMA authorised it on 26 May 2023.
Who is the marketing authorisation holder for Sodium Thiosulfate in European Union?
Fennec Pharmaceuticals (EU) Limited holds the EU marketing authorisation.