Provera Tablets 100 mg

  • Name:

    Provera Tablets 100 mg

  • Company:
    info
  • Active Ingredients:

    Medroxyprogesterone Acetate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/10/15

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Summary of Product Characteristics last updated on medicines.ie: 31/5/2016
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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
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Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
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Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
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1 - 0 of 227 items.Total: Infinity pages

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 31 May 2016 SmPC

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 SmPC

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 PIL

Reasons for updating

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

Updated on 19 October 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 October 2015 SmPC

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 SmPC

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 PIL

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 5 November 2012 SmPC

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 1 November 2012 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 18 May 2012 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 27 April 2012 PIL

Reasons for updating

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

Updated on 20 October 2011 SmPC

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 PIL

Reasons for updating

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

Updated on 27 July 2010 SmPC

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 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 2 June 2008 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 August 2005 SmPC

Reasons for updating

  • New SPC for medicines.ie

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