Tenofovir disoproxil Mylan 245 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 12 June 2023
File name
ie-pl-v0027-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 12 June 2023
File name
ie-spc-v0027-clean.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 August 2022
File name
ie-spc-v0025G-clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 October 2021
File name
ie-pl-maht-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 26 October 2021
File name
ie-spc-maht-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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 26 October 2021
File name
ie-pl-maht-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 26 October 2021
File name
ie-spc-maht-clean.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 01 September 2021
File name
ema-spc-h-4049-en-clean-renewal.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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
SmPC updated following Renewal application.
Updated on 17 February 2021
File name
ema-spc-h-4049-en-clean-pusaandv0019.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 February 2021
File name
ie_uk-pl-clean (v019 PSUR).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 - excipient warnings
- Change to section 6 - date of revision
Updated on 13 September 2019
File name
ie-spc-h4049-v0016-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 13 September 2019
File name
ie_uk-pl-clean v016.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 19 August 2019
File name
ie-spc-h4049-v0014-clean.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 April 2019
File name
ie-pl-h4049-v0012-clean.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 26 April 2019
File name
ie-spc-h4049-v0012-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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 08 January 2019
File name
ie-pl-h4049-v0009-ipha-clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
Updated on 08 January 2019
File name
ie-spc-h4049-v0009-ipha-clean.pdf
Reasons for updating
- Change to section 6.2 - Incompatibilities
- Change to section 6.4 - Special precautions for storage
- 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 08 May 2018
File name
ema-spc-h4049-en-v0007 .docx
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of text "and uncommon events of" in section 4.8
Updated on 04 May 2018
File name
ema-spc-h4049-en-v0007 .docx
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 4.8 - 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 24 April 2018
File name
ema-pl-h4049-en .pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 31 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 27 July 2017
File name
PIL_17234_709.pdf
Reasons for updating
- New PIL for new product