Risperdal Consta 50 mg powder and solvent for prolonged-release suspension for injection
*Company:
Janssen Sciences Ireland (a Johnson & Johnson Company)Status:
No Recent UpdateLegal 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 13 September 2022
File name
PIL-RISPERDAL CONSTA-IE-WS_1877_corr.pdf
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Corrections:
Adding missing sentence in Section 2
Deletion of bullet point in Section 4
Deletion of Bulgaria and addition of United Kingdom in Section 6
Updated on 30 August 2022
File name
PI-RIS~1.PDF
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8
Frequency not known:
Stevens-Johnson syndrome/toxic epidermal necrolysis
Updated on 30 August 2022
File name
PIL-RISPERDAL CONSTA-IE-WS_1877.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 4:
Not known: frequency cannot be estimated from the available data
· Severe or life‑threatening rash with blisters and peeling skin that may start in and around the mouth, nose, eyes, and genitals and spread to other areas of the body (Stevens‑Johnson syndrome or toxic epidermal necrolysis).
Updated on 12 April 2019
File name
PIL-Risperdal Consta-C01-29mar19.pdf
Reasons for updating
- New PIL for new product
Updated on 12 April 2019
File name
IE-SMPC-Risperdal-Consta-50mg-C28-29mar19-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)