Ilumetri 100 mg solution for injection in pre-filled syringe
*Company:
Almirall LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)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 05 December 2022
File name
ie-ukni-smpc-ilumetri100mg-ipha.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated with report any suspected adverse reactions to the HPRA Pharmacovigilance, Website: www.hpra.ie
Updated on 09 August 2022
File name
m1-3-1-smpc-ilumetri-ie-ukni 20.06.2022.pdf
Reasons for updating
- Addition of joint SPC covering all presentations
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated with new additional presentation of 200 mg/2 ml solution for injection in pre-filled syringe. MAH number: EU/1?18/1323/003.
Section 4.8 updated: Immunogenicity - cases of neutralising antibodies in 7.3% of patients treated with tildrakizumab.
Updated on 23 June 2021
File name
PIL Ilumetri 100mg PFS NSD GB_IE 80018954.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
update of address of manufacturing site in Barcelona, Spain
Updated on 31 January 2020
File name
uk-ie-smpc-ilumetri.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)