MabThera 100 mg and 500 mg concentrate for solution for infusion *
Pharmacy Only: Prescription

  • Company:

    Roche Registration GmbH
  • Status:

    No Recent Update
  • Legal 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 03 September 2021

File name

PIL Mabthera IV clean 26-Aug-2021_1630685728.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_1630685602.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_1626786425.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_1626786220.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_1614775240.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)

EDM Updated on 25 November 2020

File name

03. Mabthera in Non Onc_Patient Alert Card_HPRA Approved RMinA_Nov 2014_1606306675.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 25 November 2020

File name

MabThera Non-Oncology HCP Brochure IE Version 21.1.1_1606306675.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 25 November 2020

File name

MabThera Non-Oncology Patient Leaflet IE Version 21.1.1_1606306675.pdf

Reasons for updating

  • Add New Doc

Updated on 08 October 2020

File name

PIL_Mabthera_IV_03-Sep-2020_clean_1602172732.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_1585750640.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_1585748188.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_1584023836.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_1584023653.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_1565170991.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_1565171093.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_1553162755.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_1553162976.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_1545988237.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_1545988178.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_1538467128.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_1534409396.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)