EMA — authorised 22 October 2004
- Status: approved
🇪🇺 Sensipar in European Union
EMA authorised Sensipar on 22 October 2004
Marketing authorisations
EMA — authorised 22 October 2004
- Application: EMEA/H/C/000575
- Marketing authorisation holder: Dompé Biotec S.p.A.
- Local brand name: Parareg
- Indication: Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). Reduction of hypercalcaemia in patients with: parathyroid carcinoma. primary HPT for whom parathyroidectomy would be indicated on the basis of serum calciumlevels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
- Status: withdrawn
EMA — authorised 19 November 2015
- Application: EMEA/H/C/004014
- Marketing authorisation holder: Mylan Pharmaceuticals Limited
- Local brand name: Cinacalcet Viatris (previously Cinacalcet Mylan)
- Indication: Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate. Reduction of hypercalcaemia in patients with: parathyroid carcinoma primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
- Status: approved
EMA — authorised 3 April 2020
- Application: EMEA/H/C/005236
- Marketing authorisation holder: Accord Healthcare S.L.U.
- Local brand name: Cinacalcet Accordpharma
- Indication: Secondary hyperparathyroidism AdultsTreatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric populationTreatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4). Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1)
- Status: approved
Sensipar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Sensipar approved in European Union?
Yes. EMA authorised it on 22 October 2004; EMA authorised it on 22 October 2004; EMA authorised it on 19 November 2015.
Who is the marketing authorisation holder for Sensipar in European Union?
Amgen is the originator. The local marketing authorisation holder may differ — check the official source linked above.