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.
 

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.
 

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.

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.

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).

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)

IB/154 update to in-use stability to 30 days for MabThera IV

Existing text in SmPC updated with 9 year follow-up data (final CSR) at request from Rapporteur.

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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

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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

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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