MabThera 100 mg and 500 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 03 July 2024
File name
MabThera 100mg.500mg_IV_PIL_II.0201G_16 May 2024.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 03 July 2024
File name
PI2024-303307_Mab Annexes 16 May 2024_SmPC_IV.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 01 September 2023
File name
Mab IV PIL_CLEAN_IE 29Aug2023.docx.pdf
Reasons for updating
- Change to other sources of information section
Updated on 01 September 2023
File name
Mab IV SmPC_CLEAN_IE 29Aug2023 (1).docx.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 September 2023
File name
Mab IV SmPC_CLEAN_IE 29Aug2023 (1).docx.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 September 2023
File name
Mab IV PIL_CLEAN_IE 29Aug2023.docx.pdf
Reasons for updating
- Change to other sources of information section
Updated on 24 August 2023
File name
MabThera 100mg.500mg IV_PSUSA_PIL 16 Aug 2023.pdf
Reasons for updating
- Change to section 4 - possible side effects
Updated on 24 August 2023
File name
MabThera 100mg.500mg IV_PSUSA_SmPC 16 Aug 2023.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 25 August 2022
File name
MabThera IV PIL dated Aug2022.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
Updated on 25 August 2022
File name
MabThera IV SmPC dated 17Aug2022.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 05 July 2022
File name
MabThera IV SmPC dated Aug 2021_CLEAN.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 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Republished to correct Renewal Date
Updated on 03 September 2021
File name
PIL Mabthera IV clean 26-Aug-2021.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 03 September 2021
File name
SmPC Mabthera IV clean 26 -Aug-2021.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 July 2021
File name
Irish SPC Mabthera_IV_V5.0_II-0185G_08 Jul 2021_Clean.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
- 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)
Updated on 20 July 2021
File name
Irish PIL Mabthera_IV_V6.0_II-0185G_08 Jul 2021_Clean.pdf
Reasons for updating
- New PIL for new product
Updated on 03 March 2021
File name
Irish SPC Mabthera_IV_V4.0_IB-0181_23-Feb-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)
File name
03. Mabthera in Non Onc_Patient Alert Card_HPRA Approved RMinA_Nov 2014.pdf
Reasons for updating
- Add New Doc
Updated on 08 October 2020
File name
PIL_Mabthera_IV_03-Sep-2020_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 01 April 2020
File name
PIL_Mabthera_IV_II-169_27-Feb-2020_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
EU SPC and PIL EMEA/H/C/00165/II/169.
Submission of the primary CSR for study WA29330 (Pemphix) in fulfilment of the first part of post approval commitment (PAES) listed in the Annex IID of MabThera Product Information In addition QRD template was adjusted to the latest version QRD 10.1 resulting in several editorial changes.
Updated on 01 April 2020
File name
SmPC_Mabthera_IV_II-169_27-Feb-2020_Clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- 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
EU SPC and PIL EMEA/H/C/00165/II/169.
Submission of the primary CSR for study WA29330 (Pemphix) in fulfilment of the first part of post approval commitment (PAES) listed in the Annex IID of MabThera Product Information In addition QRD template was adjusted to the latest version QRD 10.1 resulting in several editorial changes.
Updated on 12 March 2020
File name
SmPC_Mabthera_IV_V2.0_II-162_II-168_03-Mar-2020.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Merging of two procedures type EU SPC and PIL EMEA/H/C/000165/II/0162 & EMEA/H/C/000165/II/0168 : Roche Initiated - Non CDS - Non Safety. Paediatric study was sole clinical measure in MabThera Paediatric Investigation Plan (PIP) and, as per Paediatric Regulation, a Type II variation had to be submitted for CHMP assessment for the purpose of updating the SmPC with paediatric data. - Type II/162: CDS Update - Non Safety, 31.0, Type II variation to extend the indications (CDS non-safety) for MabThera. 1. Following efficacy and safety data from Clinical study report (CSR) WA25615 (also known as Paediatric Polyangiitis and Rituximab Study [PePRS]) which was conducted to fulfil the measure of the Paediatric Investigational Plan (PIP: EMEA-000308-PIP02-11-M01) agreed upon in the context of rituximab development for treatment of adult patients with GPA and MPA (RAVE study). As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC and sections 2, 3 and 4 of the Package Leaflet are updated accordingly. Furthermore, the PI is brought in line with the latest QRD template (version 10) and the opportunity is taken to combine the SmPC and PIL for 100mg and 500mg IV as they are identical except for strength specifications. In addition, the applicant took the opportunity to implement minor editorial changes in the SmPC. 2. Section 4.4 Warning and Precautions: update to clarify existing immunization recommendations.
Updated on 12 March 2020
File name
PIL_Mabthera_IV_V2.0_II-162_II-168_03-Mar-2020.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to warnings or special precautions for use
Free text change information supplied by the pharmaceutical company
Merging of two procedures type EU SPC and PIL EMEA/H/C/000165/II/0162 & EMEA/H/C/000165/II/0168 : Roche Initiated - Non CDS - Non Safety. Paediatric study was sole clinical measure in MabThera Paediatric Investigation Plan (PIP) and, as per Paediatric Regulation, a Type II variation had to be submitted for CHMP assessment for the purpose of updating the SmPC with paediatric data. - Type II/162: CDS Update - Non Safety, 31.0, Type II variation to extend the indications (CDS non-safety) for MabThera. 1. Following efficacy and safety data from Clinical study report (CSR) WA25615 (also known as Paediatric Polyangiitis and Rituximab Study [PePRS]) which was conducted to fulfil the measure of the Paediatric Investigational Plan (PIP: EMEA-000308-PIP02-11-M01) agreed upon in the context of rituximab development for treatment of adult patients with GPA and MPA (RAVE study). As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC and sections 2, 3 and 4 of the Package Leaflet are updated accordingly. Furthermore, the PI is brought in line with the latest QRD template (version 10) and the opportunity is taken to combine the SmPC and PIL for 100mg and 500mg IV as they are identical except for strength specifications. In addition, the applicant took the opportunity to implement minor editorial changes in the SmPC. 2. Section 4.4 Warning and Precautions: update to clarify existing immunization recommendations.
Updated on 08 August 2019
File name
PIL_Mabthera_IV_V1.0_IB-167_30-Jul-2019_CLEAN.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Joint PIL superseded by individual PILs
Updated on 07 August 2019
File name
SmPC_Mabthera_IV_V1.0_IB-167_30-Jul-2019_CLEAN.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
- Change from individual to joint SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 March 2019
File name
Irish PIL 5.0 MabThera 500 mg Concentrate for Solution for Infusion.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 21 March 2019
File name
Irish SPC 7.0 MabThera 500 mg Concentrate for Solution for Infusion 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 4.3 - Contraindications
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Non Safety, 29.0, Addition of a new therapeutic indication for MabThera (rituximab) for the treatment of patients with moderate to severe pemphigus vulgaris (PV) for MA numbers EU/1/98/067/001 – 002 (MabThera 100 mg concentrate for solution for infusion and MabThera 500 mg concentrate for solution for infusion, respectively).
Updated on 28 December 2018
File name
uk-ie-mt-pil-mabthera-clean-181218-500mg-inf.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 28 December 2018
File name
uk-ie-mt-spc-mabthera-clean-181218-500mg-inf.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- 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)
Free text change information supplied by the pharmaceutical company
EMEA/H/C/000165/II/0149 (Addition of a new therapeutic indication in GPA/MPA M(update of section 4.1, 4.2, 4.8 and 5.1)
Updated on 02 October 2018
File name
uk-ie-mt-spc-mabthera-clean-180924-500mg-inf.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
IB/154 update to in-use stability to 30 days for MabThera IV
Updated on 16 August 2018
File name
uk-ie-mt-pil-mabthera-clean-180809-500mg-inf.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 29 May 2018
File name
uk-ie-mt-spc-mabthera-clean-180426-500-inf.docx
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)
Free text change information supplied by the pharmaceutical company
Existing text in SmPC updated with 9 year follow-up data (final CSR) at request from Rapporteur.
Updated on 28 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 March 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
Underlined text has been added, text with strike-through deleted:
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
16 March 2018
Updated on 26 March 2018
File name
PIL_17256_772.pdf
Reasons for updating
- New PIL for new product
Updated on 26 March 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 January 2018
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
Underlined text has been added, text with strike-through deleted:
6.3 Shelf life
Unopened vial
30 months
Diluted medicinal product
The prepared infusion solution of MabThera in 0.9% sodium chloride solution is physically and chemically stable for 24 7 days hours at 2 °C ‑ 8 °C and subsequently for a further 124 hours at ≤ 30 °Cat room temperature. The prepared infusion solution of MabThera in 5% D-glucose solution is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently for a further 12 hours at room temperature.
From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, in‑use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C – 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
10. DATE OF REVISION OF THE TEXT
13 January 2018
Updated on 15 August 2017
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Underlined text has been added, text with strike-through deleted:
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[…]
Excipients with known effects:
This medicinal product contains less than 1mmol sodium per dose, i.e. essentially sodium free.
[…]
4.2 Posology and method of administration
[…]
Maintenance therapy
· Previously untreated follicular lymphoma
The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is:
1400 mg once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 administrations in total).
· Relapsed/refractory follicular lymphoma
The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is:
1400 mg once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 administrations in total).
[…]
4.4 Special warnings and precautions for use
[…]
Excipients: This medicinal product contains 2.3 mmol (or 52.6 mg ) sodium per 10 mL vial. To be taken into consideration by patients on a controlled sodium diet.
[…]
4.8 Undesirable effects
[…]
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
[…]
10. DATE OF REVISION OF THE TEXT
04 August 2017
Updated on 10 August 2017
Reasons for updating
- New individual PIL (was previously included in a combined PIL)