Beovu 120 mg/ml solution for injection in pre-filled syringe
*Company:
Novartis Ireland LimitedStatus:
UpdatedLegal 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 25 September 2024
File name
Beovu REG SPC PF24-185 September 2024_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Removal of the black triangle for additional monitoring
- Section 2 updated to include polysorbate 80 as an ‘excipient with known effect.
- Section 4.4 updated to include sections for the ‘Sodium content’ and ‘Polysorbate 80 content’
Updated on 25 September 2024
File name
Beovu PFS REG PIL PF24-185 September 2024_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to information about pregnancy or lactation
Free text change information supplied by the pharmaceutical company
Addition of following sentence: Beovu should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child.
Addition of new section: 'Beovu contains polysorbates'
Removal of black triangle for additional reporting
Updated on 02 September 2024
File name
Beovu PFS REG PIL PF24-015 July 2024_clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
New side effect added 'inflammation of the white outer coating of the eye (scleritis)'
Updated on 02 September 2024
File name
Beovu REG SPC PF24-015 July 2024_clean 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
Addition of 'scleritis' as uncommon ADR
Updated on 26 August 2024
File name
Beovu PFS REG PIL PF22-178 and 23-069 June 2023 clean_updated to remove UK(NI).pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Free text change information supplied by the pharmaceutical company
Updated to remove UK(NI) from the sections on reporting side effects and local contacts
Updated on 17 August 2023
File name
Beovu PFS REG PIL PF22-178 and 23-069 June 2023 clean.pdf
Reasons for updating
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Improve readability of figures in dosing section
Updated on 12 July 2023
File name
Beovu PFS REG PIL PF22-178 and 23-069 June 2023_IPHA.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Alternative dosing/maintenance regimen for DME and wAMD
Change in frequency of some side effects
Updated on 12 July 2023
File name
Beovu REG SPC PF22-178 & 23-069 June 2023_IPHA.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
nAMD label update based on Modelling & Simulation, alternative posology:
· Section 4.2: Updated the posology for wAMD to include the following alternative loading regimen: ‘Alternatively, 6 mg brolucizumab (0.05 ml solution) may be administered every 6 weeks for the first 2 doses. A disease activity assessment is suggested 12 weeks (3 months) after treatment start. A third dose may be administered based on disease activity as assessed by visual acuity and/or anatomical parameters at week 12.’
· Section 5.1: Updated to include the results of the PK/PD model simulation study
DME posology & 100-week KESTREL/KITE variation:
- Section 4.2: Updated the posology for DME based on the KITE study to include 16 week or 4 months extension during maintenance phase for the DME dosing: ‘. After 12 months of treatment, in patients without disease activity, treatment intervals up to 16 weeks (4 months) could be considered’
- Section 4.8: Two sentences were added above the ADR Table 1 regarding iridocyclitis, retinal vascular occlusion and vitreous haemorrhage since these were observed at a higher frequency (category of common) in the pooled DME Phase III studies. The immunogenicity sub-section for DME was updated with the KESTREL and KITE 2-year data.
- Section 5.1: Updated to provide the updated (Week 100) safety and efficacy data from the KESTREL and KITE DME studies
Updated on 28 November 2022
File name
Your Guide to Therapy with Beovu - Audio - Aug 2022.mp3
Reasons for updating
- Add New Audio
Updated on 28 November 2022
File name
IE203173_Beovu_Patient_Therapy_Guide_Booklet_Aug2022.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
First upload to medicines.ie
Updated on 05 April 2022
File name
Beovu PFS_REG PIL_PF21-060_March 2022 IPHA.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 3 - dose and frequency
- Change to section 3 - duration of treatment
Free text change information supplied by the pharmaceutical company
Updated due to new DME indication
Updated on 05 April 2022
File name
Beovu_REG SPC_PF21-060 March 2022_IPHA.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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New DME indication
Information on (limited) experience in diabetic patients added to Section 4.4 'Special warnings and precautions for use'
Results from study in pregnant cynomolgus monkeys added to Section 4.6 'Fertility, pregnancy & lactation' and Section 5.3 'Preclinical safety data'
Updated on 14 December 2021
File name
Beovu REG PIL PF21-241 November 2021 IPHA.pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Last sentence in the "Commonly asked Q&A section" was omitted in error
Updated on 30 November 2021
File name
Beovu PFS_REG PIL_PF21-241 TBI 03 March 2021 (expedited)_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
Updated on 30 November 2021
File name
Beovu REG SPC PF21-241 November 2021_IPHA.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update Section 4.2 to remove "The physician may further individualise treatment intervals based on disease activity" from the posology
Update Section 4.4 warning on intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion and instructions that the interval between two Beovu doses during maintenance treatment should not be less than 8 weeks.
Update adverse drug reactions in Section 4.8 to remove "retinal artery occlusion" and to include "retinal vasculitis" and "retinal vascular occlusion" with frequency "unknown"
Updated on 13 April 2021
File name
Beovu REG PIL PF21-047 TBI 01.11.2021 IPHA.pdf
Reasons for updating
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Figure 5 changed to a clearer picture
Updated on 19 November 2020
File name
Beovu REG PIL PF20-0096 TBI20.1.2021.pdf
Reasons for updating
- New PIL for new product
Updated on 19 November 2020
File name
Beovu REG SmPC 120mg-ml_Soln_Inj_14-Oct-20_PF20-0096 Sept 2020clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)