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Withdrawn

This medicine's authorisation has been withdrawn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The marketing authorisation for Parareg has been withdrawn at the request of the marketing authorisation holder.

Parareg : EPAR - Summary for the public

English (EN) (268.15 KB - PDF)

First published: Last updated:
View

български (BG) (407.85 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

español (ES) (270.36 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

čeština (CS) (391.51 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

dansk (DA) (269.6 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

Deutsch (DE) (271.46 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

eesti keel (ET) (307.8 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

ελληνικά (EL) (404.21 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

français (FR) (271.07 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

italiano (IT) (270.63 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

latviešu valoda (LV) (389.42 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

lietuvių kalba (LT) (387.52 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

magyar (HU) (380.13 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

Malti (MT) (391.48 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

Nederlands (NL) (270.52 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

polski (PL) (398.6 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

português (PT) (270.61 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

română (RO) (380.1 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

slovenčina (SK) (385.62 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

slovenščina (SL) (376.47 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

Suomi (FI) (270.06 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

svenska (SV) (269.32 KB - PDF)

First published: 13/05/2009Last updated: 13/05/2009
View

Product information

Parareg : EPAR - Product Information

English (EN) (774.82 KB - PDF)

First published: Last updated:
View

български (BG) (1.2 MB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

español (ES) (901.88 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

čeština (CS) (1.05 MB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

dansk (DA) (825.74 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

Deutsch (DE) (869.84 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

eesti keel (ET) (944.64 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

ελληνικά (EL) (1.32 MB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

français (FR) (920.91 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

italiano (IT) (847.73 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

latviešu valoda (LV) (1.1 MB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

lietuvių kalba (LT) (1.02 MB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

magyar (HU) (984.21 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

Malti (MT) (995.38 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

Nederlands (NL) (797.04 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

polski (PL) (1.1 MB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

português (PT) (270.61 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

română (RO) (380.1 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

slovenčina (SK) (385.62 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

slovenščina (SL) (376.47 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

Suomi (FI) (815.99 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

svenska (SV) (269.32 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View
Latest procedure affecting product information: II/0015
29/10/2008
icon globe

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).

Parareg : EPAR - All Authorised presentations

English (EN) (273.4 KB - PDF)

First published: Last updated:
View

español (ES) (278.46 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

čeština (CS) (301.78 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

dansk (DA) (280.2 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

Deutsch (DE) (281.12 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

eesti keel (ET) (279.83 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

ελληνικά (EL) (298.99 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

français (FR) (279.51 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

italiano (IT) (278.06 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

latviešu valoda (LV) (298.54 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

lietuvių kalba (LT) (299.23 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

magyar (HU) (299.73 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

Nederlands (NL) (279.14 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

polski (PL) (303.49 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

português (PT) (277.01 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

slovenčina (SK) (301.84 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

slovenščina (SL) (299.12 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

Suomi (FI) (278.28 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

svenska (SV) (278.89 KB - PDF)

First published: 14/05/2009Last updated: 14/05/2009
View

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

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

English (EN) (270.03 KB - PDF)

First published: Last updated:
View

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

English (EN) (664.57 KB - PDF)

First published: Last updated:
View

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

AdoptedReference Number: EMEA/CHMP/206494/2008

English (EN) (33.38 KB - PDF)

First published: Last updated:
View

Parareg : EPAR - Scientific Discussion

English (EN) (794.49 KB - PDF)

First published: Last updated:
View

Parareg : EPAR - Procedural steps taken before authorisation

English (EN) (306.64 KB - PDF)

First published: Last updated:
View

More information on Parareg

Public statement on Parareg: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMEA/686673/2008

English (EN) (21.98 KB - PDF)

First published: Last updated:
View
This page was last updated on

Share this page

Back to top