Provera 10mg Tablets * Pharmacy Only: Prescription
Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
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 unknownUpdated 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