Parareg

RSS

cinacalcet

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Parareg has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 14/05/2009

Authorisation details

Product details
Name
Parareg
Agency product number
EMEA/H/C/000575
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
Publication details
Marketing-authorisation holder
Dompé Biotec S.p.A.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
22/10/2004
Contact address
Via San Martino 12
I-20122 Milan
Italy

Product information

29/10/2008 Parareg - EMEA/H/C/000575 - II/0015

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

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