Prostin E2 Vaginal Tablets 3 mg
- Name:
Prostin E2 Vaginal Tablets 3 mg
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to restricted prescription (C)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/08/15
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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 20 August 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to restricted prescription (C)
Updated on 20 August 2015 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4 - Clinical particulars
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5 - Pharmacological properties
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 5.4 - Radiation dosimetry
- Change to section 6 - Pharmaceutical particulars
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 8 - MA number
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to section 11 - Dosimetry
- Change to section 12 - Instructions for preparation of radiopharmaceuticals
Legal category: Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
All sections – Updated in line with QRD
Updated on 18 August 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 18 August 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to improve clarity and readability
Updated on 20 February 2014 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 7 change to name of marketing authorization holder
Section 8: change to the marketing authorization number
Section 10 Change to the date of revision of text
Updated on 13 February 2014 PIL
Reasons for updating
- Change of licence holder
- Change to date of revision
- Change to marketing authorisation holder
Updated on 9 July 2013 PIL
Reasons for updating
- Improved electronic presentation
Updated on 16 December 2011 PIL
Reasons for updating
- Change to name of manufacturer
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 restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 17 October 2011 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 26 July 2011 PIL
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
- Change due to user-testing of patient information
Updated on 17 November 2010 SmPC
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category: Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 4.4 – Special warnings and special precautions for Use
Section 4.6 – Pregnancy and Lactation
Section 4.8 - Undesirable effects
Section 4.9 – Overdose
Updated on 15 November 2010 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 14 July 2010 PIL
Reasons for updating
- Change to date of revision
- Introduction of new strength
Updated on 13 July 2010 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.4 - Special precautions for storage
Legal category: Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Section 1 – Re arrangement of product trade name
Section 2 – Deletion of “Also contains 0.742g of lactose anhydrous and addition of a word “ a full list of “ & “section”
Section 6.4 – Special precautions for storage – addition of “in order to protect from moisture”
Updated on 18 June 2009 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 20 July 2007 PIL
Reasons for updating
- Improved electronic presentation
Updated on 20 February 2006 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 17 February 2006 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 7 - Marketing authorisation holder
Legal category: Product subject to restricted prescription (C)
Updated on 7 July 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to restricted prescription (C)