Provera Tablets 2.5mg *
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

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

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

  • 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

File name

PIL_13191_755.pdf

Reasons for updating

  • New PIL for new product

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 16 December 2014

Reasons for updating

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

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 19 June 2012

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 7: MARKETING AUTHORISATION HOLDER
Section 8: MARKETING AUTHORISATION NUMBER

Updated on 19 June 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

Section 7: MARKETING AUTHORISATION HOLDER
Section 8: MARKETING AUTHORISATION NUMBER

Updated on 24 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 24 October 2011

Reasons for updating

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

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 19 August 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Sections 2 and 6.5
Section 4.3, 4.4, 4.5 and 4.8 of Provera 2.5mg and 5 mg tablets is harmonised with the relevant sections of Provera 10 mg tablets.

Updated on 19 August 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • 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

Sections 2 and 6.5
Section 4.3, 4.4, 4.5 and 4.8 of Provera 2.5mg and 5 mg tablets is harmonised with the relevant sections of Provera 10 mg tablets.

Updated on 28 May 2008

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 28 May 2008

Reasons for updating

  • New SPC for medicines.ie