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25 mg/ml
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25 mg/ml
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Drug name: Gazyvaro ®

INN: Obinutuzumab

API type: Obinutuzumab is a Type II humanised anti-CD20 monoclonal antibody of the IgG1 subclass derived by humanisation of the parental B-Ly1 mouse antibody and produced in the Chinese Hamster Ovary cell line by recombinant DNA technology.

Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies

ATC code: L01XC15

General function:

Short description:

Original license holder:

Marketing authorisation numbers: EU/1/14/937/001

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: Roche Diagnostics GmbH; Nonnenwald 2; 82377 Penzberg; Germany

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

Max shelf life: 36 months

Storage conditions: 2°C – 8°C

List of excipients: L-histidine, L-histidine hydrochloride monohydrate, Trehalose dihydrate, Poloxamer 188, Water for injections