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Rituximab / Mabthera®

   
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Mabthera

10 mg/ml
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Mabthera

10 mg/ml
Note: For full product details, please login.

Mabthera

10 mg/ml
Note: For full product details, please login.

Mabthera

10 mg/ml
Note: For full product details, please login.

Mabthera

10 mg/ml
Note: For full product details, please login.

Mabthera

10 mg/ml
Note: For full product details, please login.

Drug name: Mabthera®

INN: Rituximab

API type: Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies

ATC code: L01XC02

General function:

Short description:

Original license holder:

Marketing authorisation numbers: EU/1/98/067/001 - 003

Marketing authorisation holder: Roche Registration Limited; 6 Falcon Way; Shire Park; Welwyn Garden City; AL7 1TW; United Kingdom

Name of the manufacturer of the biological active substance: Genentech Inc.; 1000 New Horizons Way; Vacaville, CA 95688; USA

Name and address of the manufacturer responsible for batch release: Roche Pharma AG; Emil-Barell-Str. 1; D-79639 Grenzach-Wyhlen; Germany

Max shelf life: 30 months

Storage conditions: 2°C – 8°C

List of excipients: Recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, Polysorbate 80, Water for injections