Parareg

RSS
Withdrawn

This medicine's authorisation has been withdrawn

cinacalcet
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Parareg has been withdrawn at the request of the marketing authorisation holder.

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Product information

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Latest procedure affecting product information: II/0015
29/10/2008
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

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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
Revision
6

Assessment history

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