Femara 2.5 mg Film Coated Tablet
*Company:
Novartis Ireland 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
Updated on 20 August 2021
File name
IPHA Femara REGPIL PF 20-0131_Jan_2021_Clean.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 25 February 2021
File name
IPHA Femera REGPIL PF 20-0131-Clean Feb 2021 (003).pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 25 February 2021
File name
Femara REGSPC PF 20-0131 Clean Feb 2021.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 12 May 2020
File name
IPHA Femara2.5mgFilCoatedTablets_REGPIL_Clean Jan 2020.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 27 November 2019
File name
IPHA_Femara2.5mgFilCoatedTablets_PIL PF19-0205 Nov 2019_Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 27 November 2019
File name
Femara REGSPC PF 19-0205 October 2019_Clean.pdf
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)
Updated on 09 May 2019
File name
Femara 2.5mg FCT 2220784_IE_p2_LFT_X-4 RA reviewed 04.03.2019_IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 22 March 2019
File name
Femara 2.5mg FCT 2214529_IE_p2_LFT_X-4 RA approved 23.08.2018 IPHA.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 22 January 2019
File name
Femara 2.5mg FCT 2214529_IE_p2_LFT_X-4 RA approved 23.08.2018 IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 24 July 2018
File name
Femara REGSPC_Clean July 2018.pdf
Reasons for updating
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 July 2018
File name
Femara REGSPC_Clean July 2018.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 September 2015
File name
PIL_8509_495.pdf
Reasons for updating
- New PIL for new product
Updated on 03 September 2015
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 23 April 2014
Reasons for updating
- Change to warnings or special precautions for use
Updated on 21 December 2012
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to how the medicine works
Updated on 14 April 2009
Reasons for updating
- Change to information about pregnancy or lactation
- Change to side-effects
Updated on 05 September 2008
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
Updated on 30 January 2007
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 29 August 2006
Reasons for updating
- Change to, or new use for medicine
Updated on 16 May 2005
Reasons for updating
- Change to, or new use for medicine
Updated on 25 August 2004
Reasons for updating
- New PIL for medicines.ie