Caprelsa (vandetanib)
- Region
- 🇪🇺 EU
- Active substance
- vandetanib
- Company
- Esteve Pharmaceuticals, S.A.
- Status
- Authorised
- Therapeutic area
- Thyroid Neoplasms
- CHMP opinion
- Thu 17 Nov 2011
- EU approval
- Thu 16 Feb 2012
- Application
- EMEA/H/C/002315
- ATC
- L01XE
- Official record
- www.ema.europa.eu
Indication
Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, children and adolescents aged 5 years and older. For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Zactima Application withdrawn · AstraZeneca
Follow Caprelsa
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.