Femoston-Conti 0.5/2.5mg film-coated tablet
*Company:
Mylan IRE Healthcare LtdStatus:
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 28 November 2023
File name
ie-pl-nl2280-0.5mg2.5mg-v046 - clean - 000878049.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 28 November 2023
File name
ie-pl-nl2280-0.5mg2.5mg-v046 - clean - 000878049.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 28 November 2023
File name
ie-pl-nl2280-0.5mg2.5mg-v046 - clean - 000878049.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 28 November 2023
File name
ie-pl-nl2280-0.5mg2.5mg-v046 - clean - 000878049.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 28 November 2023
File name
ie-pl-nl2280-0.5mg2.5mg-v046 - clean - 000878049.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 28 November 2023
File name
ie-spc-nl2280-0.5mg2.5mg-v046 - clean - 000878053.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 November 2023
File name
ie-spc-nl2280-0.5mg2.5mg-v046 - clean - 000878053.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 May 2022
File name
ie-pl-nl2280-0.5mg2.5mg-v042-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 04 May 2022
File name
ie-spc-nl2280-0.5mg2.5mg-v042-clean.pdf
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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 November 2020
File name
ie-spc-nl2280-0.5mg2.5mg-v038-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 November 2020
File name
ie-pl-nl2280-0.5mg2.5mg-v038-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 20 March 2020
File name
ie-pl-nl2280-0.5mg2.5mg-v037-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to product name
Free text change information supplied by the pharmaceutical company
Change the name of the medicinal product in Spain
Updated on 25 October 2019
File name
IE-SmPC-Femoston-conti 0.5mg2.5mg-21Oct2019-WS337-CRN008Y22-emc.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 September 2019
File name
IE-MT-PIL-Femoston-conti 0.5mg2.5mg-20Aug2019-V035-emc.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to further information section
Updated on 13 August 2019
File name
IE-MT-PIL-Femoston-conti 0.5mg2.5mg-10Aug2019-V034-emc.pdf
Reasons for updating
- Change to further information section
Updated on 12 August 2019
File name
IE-MT-PIL-Femoston-conti 0.5mg2.5mg-07Aug2019-V030-emc.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
Updated on 12 August 2019
File name
IE-SmPC-Femoston-conti 0.5mg2.5mg-07Aug2019-V030-emc.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 May 2019
File name
IE-MT-PIL-Femoston-conti 0.5mg2.5mg-add MT-13May2019-emc.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 04 July 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 July 2017
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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
7. MARKETING AUTHORISATION HOLDER
Mylan IRE Healthcare Limited
Unit 35/36
Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland
BGP Products Ireland Limited
4051 Kingswood Drive,
Citywest Business Campus,
Dublin 24
8. MARKETING AUTHORISATION NUMBER
PA 2010/12/3 2007/8/3
10. DATE OF REVISION OF THE TEXT
June 2017
Updated on 30 June 2017
File name
PIL_16360_103.pdf
Reasons for updating
- New PIL for new product
Updated on 30 June 2017
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 08 August 2016
Reasons for updating
- Change to further information section
Updated on 15 March 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
In section 4.8 - Update text for 'Ovarian cancer' section, correction of spelling errors in adverse events table
Updated on 15 March 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
Updated on 10 September 2015
Reasons for updating
- Improved electronic presentation
Updated on 10 August 2015
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 30 July 2015
Reasons for updating
- Change to date of revision
- Correction of spelling/typing errors
Updated on 11 June 2015
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 09 June 2015
Reasons for updating
- New PIL for medicines.ie