Provera Tablets 2.5mg
- Name:
Provera Tablets 2.5mg
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 27/05/16
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Pfizer Healthcare Ireland
Company Products
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 PIL
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 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 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 27 May 2016 PIL
Reasons for updating
- New PIL for new product
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 unknownUpdated on 16 December 2014 PIL
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 unknownUpdated on 19 June 2012 PIL
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 8: MARKETING AUTHORISATION NUMBER
Updated on 19 June 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
Section 8: MARKETING AUTHORISATION NUMBER
Updated on 24 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
Updated on 24 October 2011 PIL
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
Updated on 19 August 2010 PIL
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 SmPC
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 SmPC
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 PIL
Reasons for updating
- New SPC for medicines.ie