Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan *

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 05 October 2021

File name

ie-spc-MAHT-clean_1633421899.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 05 October 2021

File name

ie-pl-MAHT-clean_1633421859.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 28 July 2021

File name

emea-spc-h-4240-en (clean v017)_1627476321.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

(Ref: EMEA/H/C/004240/IB/0017) Changes to the Summary of Product Characteristics and Package Leaflet to extend the PRAC conclusions from PSUSA on Metamizole (PSUSA/0001997/202003) to efavirenz-containing products

Updated on 28 July 2021

File name

Package leaflet (IE) - clean v017_1627476263.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Free text change information supplied by the pharmaceutical company

(Ref: EMEA/H/C/004240/IB/0017) Changes to the Summary of Product Characteristics and Package Leaflet to extend the PRAC conclusions from PSUSA on Metamizole (PSUSA/0001997/202003) to efavirenz-containing products

Updated on 27 April 2021

File name

Efavirenz Emtricitabine Tenofovir SPC_1619531540.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 27 April 2021

File name

Efavirenz Emtricitabine Tenofovir PIL_1619531493.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 24 February 2021

File name

emea-spc-clean (v013)_1614198905.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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 24 February 2021

File name

Package leaflet (IE) - clean v013_1614198867.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 10 March 2020

File name

SmPC (IE only) (v009) - clean_1583842432.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 10 March 2020

File name

Leaflet (IE-UK) (v009)- clean_1583842399.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
  • Change to section 6 - date of revision

Updated on 31 May 2019

File name

Package leaflet (v007 14May2019)- clean_1559157873.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 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder

Updated on 29 May 2019

File name

SmPC (v00714May2019)-clean_1559157950.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 July 2018

File name

Package leaflet (v001 17May2018).pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product looks like and pack contents

Updated on 19 July 2018

File name

SUMMARY OF PRODUCT CHARACTERISTICS (v001 17May2018).pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 July 2018

File name

SUMMARY OF PRODUCT CHARACTERISTICS (MAA Sep2017).docx

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 July 2018

File name

Package leaflet (MAA Sep2017).pdf

Reasons for updating

  • New PIL for new product