Indivina 2 mg/5 mg tablets
- Name:
Indivina 2 mg/5 mg tablets
- 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: 04/02/21
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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 4 February 2021 SPC
Reasons for updating
- 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.4 Special warnings and precautions for use
Breast cancer section updated to include the results from a large meta-analysis showed that after stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of prior HRT use. When HRT was taken for more than 5 years, the risk may persist for 10 years or more.
4.5 Interaction with other medicinal products and other forms of interaction
Information on co-administerion of sex hormones and combinations of HIV protease inhibitors added.
4.8 Undesirable effects
Updated to include more detailed information on the risks of breast cancer associated with HRT.
Updated on 4 February 2021 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
Updated information on breast cancer risks associated with HRT.
Updated on 28 January 2021 PIL
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
Admistrative reorganisation of documents
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 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 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 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