OCREVUS 300 mg concentrate for solution for infusion
*Company:
Roche Registration GmbHStatus:
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 05 April 2023
File name
Ocrevus_II-0035_30Mar2023_SmPC.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 September 2022
File name
Ocrevus R-033 21-Sep-2022_SmPC_1.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 September 2022
File name
Ocrevus R-033 21-Sep-2022_PL_1.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to information for healthcare professionals
- Removal of Black Inverted Triangle
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 24 May 2021
File name
SmPC_Ocrevus_II-024_09-Apr-2021_Clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2021
File name
PIL_Ocrevus IB-025_20-Apr-2021_V2.0_Clean.pdf
Reasons for updating
- New PIL for new product
Updated on 21 May 2021
File name
SmPC_Ocrevus IB-025_20-Apr-2021_V2.0_Clean.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 April 2021
File name
SmPC_Ocrevus IB-025_20-Apr-2021_Clean.pdf
Reasons for updating
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 April 2021
File name
SmPC_Ocrevus_II-023_04-Mar-2021_Clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 March 2021
File name
Irish SPC Ocrevus_V10.0_II-021_11-Feb-2021_CLEAN.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2021
File name
SmPC_Ocrevus_PSUSA 5_11Jan2021_Clean.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 January 2021
File name
PIL_Ocrevus_PSUSA 5_11Jan2021_Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 12 January 2021
File name
SmPC_Ocrevus_II-020_26-Nov-2020_Clean.pdf
Reasons for updating
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 June 2020
File name
SmPC_Ocrevus_II-017_30-Apr-2020_clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
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/0017
This variation is being submitted to support the addition of language in Annex I SmPC and Annex III B Package Leaflet, to allow for an alternative option of a shorter infusion for second and subsequent doses of Ocrevus® (2 hours, compared to the approved 3.5 hours infusion). The following sections have been updated: - SmPC Section 4.2, Posology and administration - SmPC Section 4.8, Undesirable effects - SmPC Section 5.1, Pharmacodynamic properties - Package Leaflet, Section 'How much and how often you will be given Ocrevus'. We have also taken this opportunity to correct some grammatical errors in the Package Leaflet i.e. removal of additional spaces or punctuation. These edits are shown in tracked changes in the annotated version.
Updated on 03 June 2020
File name
PIL_Ocrevus_II-017_30-Apr-2020_clean.pdf
Reasons for updating
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Correction of spelling/typing errors
Updated on 24 April 2020
File name
SmPC_Ocrevus_IB-018_17-Apr-20_clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
EMEA/H/C/004043/IB/0018. Type IB variation w/o linguistic review to extend DP shelf life from 18 to 24 months.
Updated on 24 April 2020
File name
PIL_Ocrevus_IB-018_17-Apr-20_clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Free text change information supplied by the pharmaceutical company
EMEA/H/C/004043/IB/0018. Type IB variation w/o linguistic review to extend DP shelf life from 18 to 24 months.
Updated on 06 January 2020
File name
Ocrevus SmPC dated 16 Dec 2019.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 June 2019
File name
uk-ie-mt-spc-Ocrevus-clean.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
OCREVUS, EMEA/H/C/PSUSA/00010662/201809, HA Request, CDS 4 (This change was requested by PRAC following review of PBRER No.2. The change has been made under a CDS deviation, therefore CDS 4.0 remains the current version.), Following review of the PBRER#2, the PRAC requested that an explicit link between a decrease in immunoglobulins and severe infection be introduced into SmPC section 4.8
Updated on 13 December 2018
File name
uk-ie-mt-pil-ocrevus-clean-181031-300mg-inf.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 12 December 2018
File name
uk-ie-mt-spc-ocrevus-clean-181031-300mg-inf.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Vaccination data from VELOCE study added to the SmPC. PIL updated accordingly
Section 9 updated
Updated on 11 December 2018
File name
uk-ie-mt-pil-ocrevus-clean-181031-300mg-inf.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 11 December 2018
File name
uk-ie-mt-spc-ocrevus-clean-181031-300mg-inf.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 December 2018
File name
uk-ie-mt-spc-ocrevus-clean-181031-300mg-inf.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- 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
Vaccination data from VELOCE study added to the SmPC. PIL updated accordingly
updated section 9
Updated on 11 December 2018
File name
uk-ie-mt-spc-ocrevus-clean-181031-300mg-inf.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Vaccination data from VELOCE study added to the SmPC. PIL updated accordingly
Updated on 15 August 2018
File name
uk-ie-mt-pil-ocrevus-clean-180809-300mg-sol-inf.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 04 April 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 04 April 2018
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
7. MARKETING AUTHORISATION HOLDER
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
10. DATE OF REVISION OF THE TEXT
23 March 2018
Updated on 28 March 2018
File name
PIL_17397_463.pdf
Reasons for updating
- New PIL for new product
Updated on 28 March 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 17 January 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 January 2018
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
Updated on 15 January 2018
Reasons for updating
- New PIL for new product