Parareg
cinacalcet
Table of contents
Overview
The marketing authorisation for Parareg has been withdrawn at the request of the marketing authorisation holder.
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) |
|
| 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
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).
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.