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Provera 10mg Tablets

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Pharmacy Only: Prescription

Updated on 17 October 2024

File name

Reg PIL PV LD 2.5mg 10mg 10_0 IE (clean).pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Free text change information supplied by the pharmaceutical company

The PIL has been updated to reflect the SPC change for the MAH name and address.

Updated on 17 October 2024

File name

Reg SPC PV LD 10 mg 9_0 IE (clean).pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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:

Section 7 Change of MAH name and address. 


Updated on 02 October 2023

File name

RegPIL PVLD 2.5mg 10mg 9_1 IE clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Removal of one or more presentations from joint PIL
  • Correction of spelling/typing errors

Updated on 31 May 2023

File name

RegSPCPVLD10mg81IEclean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

The following changes to the labeling have been approved. Please refer to attached copy/copies of labeling documentation for full details.

The SPCs have been updated as follows:

•          Section 1 – QRD update (editorial)

•          Section 3 (10 mg only) – editorial correction

•          Section 4.4 (10 mg only) – removal of E110 (not an excipient in the 10 mg tablets)

•          Section 4.8 – update of HPRA reporting details

•          Section 10 – new revision date and reference

Updated on 12 December 2022

File name

Reg SPC PV LD 10 mg 7_0 IE (002).pdf

Reasons for updating

  • Document format updated

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

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 27 May 2016

File name

PIL_13191_755.pdf

Reasons for updating

  • New PIL for new product

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 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