Beovu 120 mg/ml solution for injection in pre-filled syringe * Pharmacy Only: Prescription
Company:
Novartis Ireland 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 April 2022
File name
Beovu PFS_REG PIL_PF21-060_March 2022 IPHA_1649151609.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_1649148368.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_1639474377.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_1638274027.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_1638271658.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_1618303152.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_1605782614.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_1605782523.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)