Overview
The marketing authorisation for Ritemvia has been withdrawn at the request of the marketing-authorisation holder.
Product information
Latest procedure affecting product information: WS/1859/G
09/10/2020
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Ritemvia
- Active substance
- rituximab
- International non-proprietary name (INN) or common name
- rituximab
- Therapeutic area (MeSH)
- Lymphoma, Non-Hodgkin
- Microscopic Polyangiitis
- Wegener Granulomatosis
- Anatomical therapeutic chemical (ATC) code
- L01XC02
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Ritemvia is indicated in adults for the following indications:
- Non-Hodgkin’s lymphoma (NHL) Ritemvia is indicated for the treatment of previously untreated patients with stage III, IV follicular lymphoma in combination with chemotherapy.
- Ritemvia maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.
- Ritemvia monotherapy is indicated for treatment of patients with stage III, IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy.
- Ritemvia is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
- Granulomatosis with polyangiitis and microscopic polyangiitis.
- Ritemvia, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).
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