Parareg

Withdrawn

This medicine's authorisation has been withdrawn

cinacalcet

Overview

On 22 October 2004 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Parareg, cinacalcet. Parareg is approved for the treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy, and for the reduction of hypercalcaemia in patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels but in whom parathyroidectomy is not clinically appropriate or is contraindicated. 

The marketing authorisation holder (MAH) responsible for Parareg was Dompé Biotec S.p.A. The European Commission was notified by letter dated 10 November 2008 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Parareg for commercial reasons. 

Parareg was only marketed in Italy. Mimpara is an identical product available in the European Union. Patients have therefore been switched to Mimpara. On 5 December 2008 the European Commission issued a decision to withdraw the marketing authorisation for Parareg. 

Pursuant to this decision the European Public Assessment Report for Parareg is updated to reflect that the marketing authorisation is no longer valid.

Parareg : EPAR - Summary for the public

Product information

Parareg : EPAR - Product Information

Parareg : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Parareg
• Active substance:
  cinacalcet
• International non-proprietary name (INN) or common name:
  cinacalcet
• Therapeutic area (MeSH):
  • Hypercalcemia
  • Parathyroid Neoplasms
  • Hyperparathyroidism
• Anatomical therapeutic chemical (ATC) code:
  H05BX01

Pharmacotherapeutic group

Calcium homeostasis

Therapeutic 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 calcium
  levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Authorisation details

• EMA product number:
  EMEA/H/C/000575
• Marketing authorisation holder:
  Dompé Biotec S.p.A.

  Via San Martino 12; I-20122 Milan; Italy

• Marketing authorisation issued:
  22/10/2004
• Withdrawal of marketing authorisation:
  05/12/2008
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Parareg : EPAR - Procedural steps taken and scientific information after authorisation

Parareg-H-C-134-II-11 : EPAR - Assessment Report - Variation

CHMP post-authorisation summary of positive opinion for Parareg on 24 April 2008

Adopted Reference Number: EMEA/CHMP/206494/2008

Initial marketing authorisation documents

Parareg : EPAR - Scientific Discussion

Parareg : EPAR - Procedural steps taken before authorisation