Provera Tablets 100 mg *
Pharmacy Only: Prescription

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

  • New SPC for new product

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

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 20 October 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

SPC section 4.2 has been updated to delete redundant word Note at the end of last paragraph in line with schedule received from HPRA .

Updated on 19 October 2015

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 19 October 2015

File name

PIL_13213_791.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 October 2015

Reasons for updating

  • 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 in section 4.8 to add erectile dysfunction and assign frequencies to all ADRs together with format change to table.

Updated on 16 December 2014

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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 warnings or special precautions for use
  • 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 05 November 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

Sections 7-Marketing authorisation holder: updated to include Pfizer Healthcare Ireland name

Section 8-Marketing authorisation number: updated to include new Product license number

 

Updated on 01 November 2012

Reasons for updating

  • Change to marketing authorisation holder

Updated on 18 May 2012

Reasons for updating

  • Change to name of manufacturer

Updated on 27 April 2012

Reasons for updating

  • Change to name of manufacturer
  • PIL retired pending re-submission

Updated on 20 October 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

SmPC changes to section 7 -  MA Holder’s name change and Section 10 – revision date.

Updated on 20 October 2011

Reasons for updating

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

Updated on 27 July 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

SmPC Sections 2 and 6.5 of the SPC was update in line with the latest SPC guidance. Pharmaceutical changes only.

Updated on 28 June 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 02 June 2008

Reasons for updating

  • New PIL for new product

Updated on 16 August 2005

Reasons for updating

  • New SPC for medicines.ie

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