Ocrevus 920 mg solution for injection
*Company:
Roche Registration GmbHStatus:
UpdatedLegal 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 01 April 2025
File name
SmPC_Ocrevus 920 mg_II-0041-13Feb2025_SmPC_2.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 April 2025
File name
SmPC_Ocrevus 920 mg_II-0041-13Feb2025_SmPC_2.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 April 2025
File name
PIL_Ocrevus 920 mg_II-0041-13Feb2025_PL_2.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 24 January 2025
File name
Ocrevus 920 mg_PSUSA-202403_13-Jan2025_SmPC_2.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 January 2025
File name
Ocrevus 920 mg_PSUSA-202403_13-Jan2025_PL_2.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 12 December 2024
File name
Ocrevus 920 mg II-0040G_31Oct2024_SmPC.pdf
Reasons for updating
- 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
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/004043/II/0040/G. Long-term safety of ocrelizumab treatment.
Updated on 24 June 2024
File name
OCR-EN-X39-200524-Clean-CD_SmPC_2.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 June 2024
File name
OCR-EN-X39-200524-Clean-CD_PL_2.pdf
Reasons for updating
- New PIL for new product
Roche Registration GmbH
Address:
3004 Lake Drive, Citywest, Naas Road, Dublin 24Medical Information E-mail:
ireland.druginfo@roche.comTelephone:
+353 1 469 0700Fax:
+353 1 469 0791