Pedmarqsi (sodium thiosulfate)
- Region
- 🇪🇺 EU
- Active substance
- sodium thiosulfate
- Company
- Norgine B.V.
- Status
- Authorised
- Therapeutic area
- Ear Diseases; Ototoxicity
- EU approval
- Fri 26 May 2023
- Application
- EMEA/H/C/005130
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Follow Pedmarqsi
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.