BENETOR PLUS 20mg/12.5mg and 20mg/25mg film-coated tablets
*Company:
Daiichi Sankyo Ireland LtdStatus:
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 09 March 2022
File name
Benetor-Plus-20mg-combined-SmPC-v16-020322-(IA autoimmune hep)-clean.pdf
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Type IA - warning for autoimmune hepatitis
Updated on 09 March 2022
File name
PIL-Benetor-Plus-20mg-v16-020322(IA autoimmune hep)-clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Type IA - warning for autoimmune hepatitis
Updated on 22 December 2021
File name
Benetor-Plus-20mg-combined-SmPC-v15-171221-(PSUSA-ARDS)-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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Type IAin-PSUSA-ARDS
Updated on 22 December 2021
File name
PIL-Benetor-Plus-20mg-v15-171221-(PSUSA-ARDS)-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Type IA-PSUSA-ARDS
Updated on 09 June 2020
File name
Benetor-Plus-20mg-combined-SmPC~V14-020620-(IA choroidal effusion)-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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated following Type IA Choroidal Effusion
Updated on 09 June 2020
File name
PIL-Benetor-Plus-20mg~V14-020620-(IA choroidal effusion)-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Updated for Type IA Choroidal Effusion
Updated on 23 November 2018
File name
PIL-Benetor-Plus-20mg~V13-221118-(PRAC signal-NMSC & HCTZ)-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 22 November 2018
File name
Benetor-Plus-20mg-combined-SmPC~V13-221118-(PRAC signal-NMSC & HCTZ)-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 23 December 2016
File name
PIL_11420_323.pdf
Reasons for updating
- New PIL for new product
Updated on 23 December 2016
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 July 2016
Reasons for updating
- Change to storage instructions
- Change to date of revision
Updated on 05 February 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
Updated on 17 November 2014
Reasons for updating
- Change to warnings or special precautions for use
Updated on 11 November 2014
Reasons for updating
- Change to warnings or special precautions for use
- Addition of information on reporting a side effect.
Updated on 28 July 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to further information section
Updated on 21 December 2011
Reasons for updating
- Change due to harmonisation of PIL
Updated on 11 October 2011
Reasons for updating
- Improved electronic presentation
Updated on 21 April 2010
Reasons for updating
- Change of contraindications
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to marketing authorisation holder
Updated on 26 September 2006
Reasons for updating
- Improved electronic presentation
Updated on 06 September 2006
Reasons for updating
- Correction of spelling/typing errors
Updated on 04 September 2006
Reasons for updating
- New PIL for new product