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