Junod 60 mg solution for injection in pre-filled syringe
*Company:
Gedeon Richter IrelandStatus:
UpdatedLegal 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 23 January 2026
File name
Junod_SmPC_en_EU-1-25-1933 version 02.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Update the warning regarding treatment discontinuation - following denosumab discontinuation, decrease in bone mineral density (BMD) is expected, leading to an increased risk for fractures.
Section 5.1 – Addition of new information for paediatric patients - denosumab should not be used in paediatric patients with glucocorticoid-induced osteoporosis.
File name
HCP Cover Letter_Oct 2025_HPRA approved 60 mg.pdf
Reasons for updating
- Add New Doc
File name
HCP Cover Letter_Oct 2025_HPRA approved 60 mg.pdf
Reasons for updating
- Add New Doc
File name
Junod RMM Patient Alert Card Ireland_05.pdf
Reasons for updating
- Add New Doc
Updated on 05 December 2025
File name
Junod_PIL_en_EU-1-25-1933.pdf
Reasons for updating
- New PIL for new product
Updated on 05 December 2025
File name
Junod_SmPC_en_EU-1-25-1933.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Gedeon Richter Ireland
 Ltd.webp)
Address:
4045 Kingswood Road, Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
medinfo.uk@gedeonrichter.euTelephone:
00 44 207 604 8800Medical Information Direct Line:
00 44 207 604 8806