Balversa 3mg, 4mg and 5mg film-coated tablets
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
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 30 April 2026
File name
EN_IE-Balversa_SmPC_20260424_IA_EMA_VR_0000340655_Clean-approved_EDMS-ERI-137304389_42.0.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMA/VR/0000340655 - Type IA - PRAC Request for Growth Acceleration in Pediatrics
Updated on 30 April 2026
File name
EN_IE-Balversa_PIL_20260424_IA_EMA_VR_0000340655_Clean-approved_EDMS-ERI-137304389_42.0.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
EMA/VR/0000340655 - Type IA - PRAC Request for Growth Acceleration in Pediatrics
Updated on 28 April 2025
File name
EN-IE-Balversa-20250218-PIL-IA-248998-Clean-approved (1).pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
PIL for launch: most recent procedure = EMA/VR/000248998 - removal blister + extra updates, approved 18 Feb 2025.
Updated on 28 April 2025
File name
IE-EN-Balversa-20250218-SmPC-IA-248998-Clean-approved (2).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC for launch: most recent procedure = EMA/VR/000248998 - removal blister + extra updates, approved 18 Feb 2025.
Janssen Sciences Ireland (a Johnson & Johnson Company)
Address:
Janssen Sciences Ireland UC, Barnahely, Ringaskiddy, IRL - Co. Cork P43 FA46Medical Information E-mail:
medinfo@its.jnj.comTelephone:
+353 1 4665200Website:
https://innovativemedicine.jnj.com/ireland/Medical Information Direct Line:
1800 709 122