Tegretol SR 400mg prolonged release tablets
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 26 May 2023
File name
Tegretol SR Tabs_REG PIL_PF23-0013_Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 26 May 2023
File name
Tegretol SR Tabs_REG PIL_PF23-0005_Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 26 May 2023
File name
Tegretol SR Tabs 400_REG SPC_May 2023_Clean_IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 March 2022
File name
Tegretol SR_REG PIL_PF 21-0277_clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
Updated on 28 March 2022
File name
Tegretol SR 400_REG SPC_Mar 2022_Clean_IPHA.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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 February 2021
File name
Tegretol SR 400_REG SPC_Feb 2021_IPHA.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 February 2021
File name
Tegretol SR_REG PIL_Feb 2021_Clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 09 September 2019
File name
Tegretol_SR200_400_REG PIL_PF18-0012_Sept 2019_Clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 09 September 2019
File name
Tegretol SR 400mg Prolonged Release Tablets REG SPC_PF18-0012_ Sept 2019_IPHA.pdf
Reasons for updating
- 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 - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 22 January 2019
File name
Tegretol SR 1230527_1230528_IE_TA_p2_LFT_X-4 RA approved 02.08.2018 IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 08 November 2018
File name
Tegretol SR 400mg Prolonged Release Tablets REGSPC_Nov 2018 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 July 2018
File name
Tegretol SR 400mg Prolonged Release Tablets REG SPC_July 2018_clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 September 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 September 2016
Reasons for updating
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 19 May 2016
File name
PIL_16744_601.pdf
Reasons for updating
- New PIL for new product
Updated on 20 October 2015
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)