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When a pharmaceutical company changes any document, 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 31 May 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

4.2    Posology and method of administration – Section updated in line with QRD.

 

4.3    Contraindications - Section updated in line with QRD.

   Undesirable effects -  Section updated in line with CDS

Updated on 31 May 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 27 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision

Updated on 27 May 2016

File name

PIL_13191_755.pdf

Reasons for updating

  • New PIL for new product

Updated on 16 December 2014

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Administrative changes in line with QRD 09

And addition of text below to Section 4.5

Medroxyprogesterone acetate (MPA) is metabolized in-vitro primarily by hydroxylation via the CYP3A4. Specific drug-drug interaction studies evaluating the clinical effects with CYP3A4 inducers or inhibitors on MPA have not been conducted and therefore the clinical effects of CYP3A4 inducers or inhibitors are unknown

Updated on 11 December 2014

Reasons for updating

  • Change to storage instructions
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability
  • Change to product name

Updated on 11 June 2012

Reasons for updating

  • Change to marketing authorisation holder

Updated on 20 October 2011

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 19 August 2010

Reasons for updating

  • Change to date of revision
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to improve clarity and readability
  • Change to drug interactions

Updated on 28 May 2008

Reasons for updating

  • New PIL for medicines.ie