Indivina
- Name:
Indivina
- Company:
Orion Pharma (Ireland) Ltd
- 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: 27/06/18


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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
Orion Pharma (Ireland) Ltd
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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 27 June 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 22 July 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 22 July 2016 PIL
Reasons for updating
- Change of manufacturer
Updated on 7 July 2016 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Updated on 7 July 2016 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 6 July 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 3 September 2015 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
Updated on 1 September 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 28 February 2014 SPC
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 25 February 2014 PIL
Reasons for updating
- Change to storage instructions
Updated on 3 May 2012 SPC
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
New individual SmPC for product (was previously in a combined SmPC).
The SmPC is updated in line with core safety text for HRT products
Updated on 2 May 2012 PIL
Reasons for updating
- Change to date of revision
Updated on 3 February 2011 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 18 March 2010 PIL
Reasons for updating
- Change to date of revision
- Improved electronic presentation
Updated on 15 August 2006 PIL
Reasons for updating
- Change to date of revision
Updated on 2 August 2005 PIL
Reasons for updating
- New PIL for medicines.ie