Femoston-Conti 0.5/2.5mg 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 16 November 2020

File name

ie-spc-nl2280-0.5mg2.5mg-v038-clean_1605523415.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_1605523332.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_1584715597.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_1572009848.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_1567411767.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_1565702018.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_1565597763.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_1565597852.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_1557755729.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

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_16360_103.pdf

Reasons for updating

  • New PIL for new product

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 4.4 - Update text for 'Ovarian cancer' section
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

Date of Renewal of Licence

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

None provided

Updated on 09 June 2015

Reasons for updating

  • New PIL for medicines.ie