MINJUVI 200 mg powder for concentrate for solution for infusion
*Company:
Incyte Biosciences UK LtdStatus:
UpdatedLegal Category:
Product subject to restricted prescription (C)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 19 December 2025
File name
ie-spc-sle-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Change in shelf life of unopened vial to 6 years
Updated on 18 December 2025
File name
ie-pl-fl-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 18 December 2025
File name
ie-spc-fl-clean.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update due to approval of extension of indication for MINJUVI in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
Updated on 26 September 2025
File name
ie-spc-annualrenewal-clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Annual Renewal date added, no change to Product Information
Updated on 03 October 2024
File name
MINJUVI-ie-pl-clean.pdf
Reasons for updating
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
Update to reconstituted solution (prior to dilution) and diluted solution (prior to dilution) based on updated stability data. Information in line with SmPC section 6.3
Updated on 03 October 2024
File name
MINJUVI-ie-spc-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update to unopened vial shelf-life from 4 years to 5 years
Update to storage conditions of reconstituted solution (prior to dilution) based upon updated stability data
Update to storage conditions of diluted solution (for infusion) based upon updated stability data
Updated on 19 July 2023
File name
ie-pl.pdf
Reasons for updating
- New PIL for new product
Updated on 19 July 2023
File name
ie-spc (1).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 31 January 2023
File name
MINJUVI-ie-spc-ATC code.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Document format updated
Updated on 03 May 2022
File name
MINJUVI-ie-pl-ATC code.pdf
Reasons for updating
- New PIL for new product
Updated on 03 May 2022
File name
MINJUVI-ie-spc-ATC code.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Incyte Biosciences UK Ltd
Address:
First Floor Q1, The Square, Randalls Way, Leatherhead, KT22 7TWMedical Information E-mail:
eumedinfo@incyte.comTelephone:
+44 800 7833711Website:
https://www.incyte.comMedical Information Direct Line:
00800 000 274 23