Luxturna concentrate and solvent for solution for injection
*Company:
Novartis Ireland LimitedStatus:
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 05 December 2024
File name
Luxturna REG PIL 24-228 November 2024 clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Change in address of manufacturer responsible for batch release
File name
NOV1077_Luxturna_RMP_Package_PIL_Audio_AUG24_v1.mp3
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Updated version following approval of new SPC/PIL in April 2024
File name
NOV1077_Luxturna_Patient_Information_Leaflet_A4_JUL24_Digital.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Updated version following approval of new SPC/PIL in April 2024
Updated on 02 May 2024
File name
Luxturna REG PIL PF24-039 April 2024 clean IPHA.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Addition of following side effect:
Not known (frequency cannot be estimated from the available data)
· Atrophy of the (chorio)retina
Updated on 02 May 2024
File name
Luxturna REG SPC PF24-039 April 2024_clean IPHA.pdf
Reasons for updating
- 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
- Section 4.8 updated to include Chorioretinal atrophy* as an Adverse Reaction with frequency ‘unknown’
(*Includes retinal degeneration, retinal depigmentation and injection site atrophy*) as an Adverse Reaction with frequency unknown
- Section 4.8 updated to include more information in the detailed description of ‘Chorioretinal atrophy’
File name
12887_Luxturna_Patient_CARD_Audio_File_CD_Updates_DEC23_v2.mp3
Reasons for updating
- Add New Audio
File name
12887_Luxturna_Audio_File_CD_Updates_DEC23_v1.mp3
Reasons for updating
- Add New Audio
Free text change information supplied by the pharmaceutical company
First upload for audio file
File name
12861_Luxturna_SurgicalManual_DEC23_LR2.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update AE reporting instructions
File name
12861_Luxturna_RMP_PharmacyManual_DEC23_LR2.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update AE reporting instructions
File name
12861_Luxturna_Patient_Infomation_Leaflet_SEPT23_LR8.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update following approval of renewal
File name
12861_Luxturna_PatientAlertCard_DEC23_LR1b.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Update AE reporting instructions
File name
Luxturna_RMP_Package_Patient_Information_Leaflet_PIL_Nov 2021 clean.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
EM for new product
File name
24.02.21 Luxturna_PATIENT_ALERT_Card_CCpdf (1) Fuse.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
EM for new product
File name
24.02.21 Luxturna_Pharmacy_Manual Fuse.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
EM for new product
File name
24.02.21 Luxturna_Surgical_Manual Fuse.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
EM for new product
Updated on 11 October 2023
File name
Luxturna REG SPC PF23-023 July 2023 clean IPHA.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
New SPC for new product
Updated on 11 October 2023
File name
Luxturna REG PIL PF23-084 July 2023 clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for new product