Darunavir Mylan 800 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    Gerard Laboratories
  • Status:

    No Recent Update
  • 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

Updated on 14 February 2022

File name

ie-PL-h-4068-v016-clean_1644834425.pdf

Reasons for updating

  • 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 6 - what the product contains

Updated on 14 February 2022

File name

ie-SPC-h-4068-v016-clean_1644834242.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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 18 November 2021

File name

ie-Pil-h-4068-en-clean-maht_1637228299.pdf

Reasons for updating

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

Updated on 18 November 2021

File name

ie-spc-h-4068-en-clean-maht_1637228259.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 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)