Provera 10mg Tablets
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
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 11 February 2025
File name
Reg PIL PV LD 10 mg 11_1 IE (clean).pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
- Removal of one or more presentations from joint PIL
Free text change information supplied by the pharmaceutical company
The PIL has been updated to remove references to the Provera 2.5 mg presentation, due to its upcoming license withdrawal
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 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
Pfizer Healthcare Ireland Unlimited Company
Address:
The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, IrelandTelephone:
+353 1 467 6500Fax:
+353 1 467 6501Website:
https://www.pfizermedicalinformation.ie/Medical Information Direct Line:
1 800 633 363