Entecavir Viatris 0.5 mg film-coated tablets
*Company:
Gerard LaboratoriesStatus:
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 13 May 2024
File name
ie-pl-h-4377-IG1688-MAT-clean-consolidated.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 13 May 2024
File name
ie-spc-h-4377-IG1688-MAT-Clean-consolidated.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 June 2022
File name
ie-pl-h-4377-r001-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 29 June 2022
File name
ie-spc-h-4377-r001-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 October 2021
File name
ie-pl-h0004377-clean-maht.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 13 October 2021
File name
ie-spc-clean-h0004377-maht.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2021
File name
ie-ema-pil-h004037-en-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 January 2021
File name
ema-spc-clean-h0004377-IE var 0005.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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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 20 January 2021
File name
ema-pl-h0004377-clean var 0005 IE - both strengths.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 21 April 2020
File name
ema-spc-clean-h0004377-IE var 0004.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 21 April 2020
File name
ema-pl-h0004377-clean var 0004 IE - both strengths.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Change to local Representatives of MAH
Updated on 11 March 2019
File name
ema-pl-h0004377-clean art61 IE.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 16 January 2018
File name
PIL_17399_258.pdf
Reasons for updating
- New PIL for new product
Updated on 16 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)