Femoston 1/10mg film-coated tablet

Product Information *

  • Company:

    Mylan IRE Healthcare Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

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 4.2 - Addition of "For oral use"
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

Correction of typo

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

None provided

Updated on 09 June 2015

Reasons for updating

  • New PIL for medicines.ie