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Amgen Ltd
240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD
Telephone: +44 (0)1223 420 305
Fax: +44 (0)1223 426 314
Medical Information Direct Line: +44 (0)1223 436 441
Medical Information e-mail: gbinfoline@amgen.com
Customer Care direct line: +44 (0)808 0100 321
Medical Information Fax: +44 (0)1223 426 314

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 22/02/2012
SPC Mimpara

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

Updated on 22/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   21-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 4.4 - Text in Seizures has been added
In Section 4.6 - Fertility text has been added:  No effects on fertility in animal studies
In Section 5.2 - Absorption, Distribution, Elimination text and PK/PD relationship text has been updated
In Section 6.6 - Disposal text - Unused medicinal product to be disposed of appropriately
In Section 10 - Date of renewal
Updated on 14/10/2009 and displayed until 22/02/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.8 (undesirable effects), included observations from post-marketing surveillance of very rare reports of angioedema and urticaria in association with cinacalcet administration.
Updated on 05/05/2009 and displayed until 14/10/2009
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:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 5.2 information on the pharmacokinetics of a single dose of cinacalcet in 12 paediatric patients is provided.
Updated on 17/07/2008 and displayed until 05/05/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   19-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.1 - addition of pHPT indication
Section 4.5 - interaction with midazolam
Section 5.1 - pHPT data
Updated on 05/11/2007 and displayed until 17/07/2008
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:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Additional information from post market surveillance added to section 4.4.
Diarrhoea added to section 4.8
Updated on 31/08/2007 and displayed until 05/11/2007
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Removal of the black triangle.
Updated on 25/08/2006 and displayed until 31/08/2007
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:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Additional text from in vitro studies added to section 5.3.
Updated on 25/04/2006 and displayed until 25/08/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   19/04/06
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

1. Additional detail regarding doses of ketoconazole, calcium carbonate, pantoprazole and desipramine tested in interaction studies (section 4.5)

2. Increase in shelf life to 4 years for both blister and tablet container (section 6.3)
Updated on 21/03/2006 and displayed until 25/04/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
Updated on 22/11/2004 and displayed until 21/03/2006
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  cinacalcet hydrochloride