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Amgen Ltd
240 Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0WD , UK
Telephone: +44 (0)1223 420 305
Fax: +44 (0)1223 426 314
Medical Information Direct Line: +44 (0)1223 436 441/Freephone: 1800 523137
Medical Information e-mail: gbinfoline@amgen.com
Customer Care direct line: +44 (0)1223 436 700/Freephone: 1800 523137
Summary of Product Characteristics last updated on medicines.ie: 08/10/2009
SPC Mimpara

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 08/10/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   31-Aug-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 2 Qualitative and Quantitative Composition/4.4 Special warnings and precautions for use includes new information on quantity of lactose in each tablet strength and galactose intolerance warning (section 4.4)

 Section 4.2 Posology and method of administration makes it clear that cinacalcet is not indicated in children and cross-refers to section 5.2 Pharmacokinetics for paediatric PK data

Section 4.4 Special warnings and precautions for use – interactions sections have been deleted since they are already included in Section 4.5 Interactions with other medicines and other forms of interaction
Updated on 11/05/2009 and displayed until 08/10/2009
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   27-Mar-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In section 5.2, pharmacokinetic data on a paediatric population has been included from a study of 12 paediatric patients given a single dose of cinacalcet.
Updated on 14/07/2008 and displayed until 11/05/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   06/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.1 - addition of primary HPT indication
Section 4.5 - interaction with midazolam included
Section 5.1 - pd data around pHPT
Updated on 01/11/2007 and displayed until 14/07/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Addition of text following post market surveillance to section 4.4
Diarrhoea added to section 4.8
Updated on 17/08/2006 and displayed until 01/11/2007
Reasons for adding or updating:
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Addition of text from in vitro studies added to section 5.3
Updated on 26/04/2006 and displayed until 17/08/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.3 - Shelf life
Updated on 21/03/2006 and displayed until 26/04/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.3 - Shelf life
Updated on 18/11/2004 and displayed until 21/03/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  cinacalcet hydrochloride