Darunavir Mylan 800 mg film-coated tablets *

  • Company:

    Gerard Laboratories
  • Status:

    Updated
  • Legal 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

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 27 September 2021

File name

ie-Pl-h-4068-en-clean-r0014_1632754344.pdf

Reasons for updating

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

Updated on 27 September 2021

File name

ie-SPC-h-4068-en-clean-r0014_1632754078.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

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

Updated on 15 January 2021

File name

ie-SPC-h-4068-en-clean-v013_1610718592.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 15 January 2021

File name

ie-PIL-h-4068-en-clean-v013_1610718550.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 19 July 2019

File name

darunavir ie-pil-h-4068-en-clean (v009Appv)-2_1563532299.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 19 July 2019

File name

Darunavir ie-spc-4068-en-clean (v009Appv)_1563532391.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 19 March 2019

File name

ie-PIL-h-4068-en-clean (vn00xx Appv)_1552990095.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 01 March 2019

File name

Darunavir 800mg Package leaflet_1551433158.pdf

Reasons for updating

  • New PIL for new product

Updated on 01 March 2019

File name

Darunavir 800mg SPC_1551448210.pdf

Reasons for updating

  • New SPC for new product

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