Femoston 1/10mg film-coated tablet *
Company:
Mylan IRE Healthcare LimitedStatus:
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
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 28 April 2021
File name
ie-spc-femoston-1mg10mg-TIB-WS006-ERA-clean_1619607163.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 17 September 2020
File name
ie-spc-femoston-1mg10mg-tiain-prac-clean_1600346468.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 17 September 2020
File name
ie-pl-femoston-1mg10mg-tiain-prac-clean_1600346420.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 14 June 2019
File name
IE-SmPC-Femoston1-10mg-05_Apr_2018-CRN2197090-clean_1560509548.pdf
Reasons for updating
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 May 2019
File name
IE-MT-PIL-Femoston 1mg-10mg-add MT-30May2019-emc_1559226817.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 10 May 2018
File name
IE-SmPC-Femoston1-10mg-05_Apr_2018-CRN2197090-clean.docx
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 April 2018
File name
IE-PIL-Femoston 1-10mg-05 Apr 2018-CRN2197090-eMC.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
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 2010/12/1 2007/8/1
10. DATE OF REVISION OF THE TEXT
June 2017
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 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 30 June 2017
File name
PIL_16361_518.pdf
Reasons for updating
- New PIL for new product
Updated on 22 September 2016
Reasons for updating
- Change of distributor details
Updated on 26 February 2016
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.3 - minor editorial updates
Section 4.4 - Addition of "meningioma" to conditions which need supervision, update text for ovarian cancer risk.
Section 4.6 - Deletion of text regarding studies in animals, addition of "Fertility" section
Section 4.8 - Comprehensive update of entire section including addition and deletion of side effects and changes of frequency of side effects. Addition of Reporting of Suspencted Adverse Reactions text.
Section 4.9 - Deletion of "No cases of overdode have been reported.." Update list of symptoms of overdose.
Section 5.1 - minor editorial update
Section 5.2 - Update of pharmacokinetic parameters tables for estradiol and dydrogesterone. Update to distribution text for estradiol. Change "metabolism" to "biotransformation"
Section 5.3 - minor editorial updates
Updated on 26 February 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to dosage and administration
Updated on 25 November 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 15 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