Lupkynis 7.9 mg soft capsules
*Company:
Otsuka Pharmaceutical UK Ltd.Status:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 22 August 2023
File name
Lupkynis SmPC_Ireland.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update of sections 4.5 and 5.2 of the SmPC in order to update pharmacokinetic and safety information based on final results from study AUR-VCS-2021-02, safety data from Phase 2 and 3 studies submitted as part of the initial marketing authorisation application and post-marketing data.
Updated on 15 February 2023
File name
Lupkynis_PIL_Ireland.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
Addition of a new pack size of 576 capsules.
Updated on 15 February 2023
File name
Lupkynis_SmPC_Ireland.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Addition of a new pack size of 576 capsules.
Updated on 05 October 2022
File name
Lupkynis_PIL_Ireland.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for New product - Lupkynis MAA approval
Updated on 05 October 2022
File name
Lupkynis_SmPC_Ireland.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
New product - Lupkynis MAA approval