Beovu 120 mg/ml solution for injection in pre-filled syringe *
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal 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)