Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
YERVOY 5 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to pale yellow liquid that may contain light (few) particulates and has a pH of 7.0 and an osmolarity of 260-300 mOsm/kg. |
Each ml of concentrate contains 5 mg ipilimumab.
One 10 ml vial contains 50 mg of ipilimumab.
One 40 ml vial contains 200 mg of ipilimumab.
Ipilimumab is a fully human anti-CTLA-4 monoclonal antibody (IgG1Îș) produced in Chinese hamster ovary cells by recombinant DNA technology.
Excipients with known effect: Each ml of concentrate contains 0.1 mmol sodium, which is 2.30 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ipilimumab |
Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of reactive T-effector cells which mobilize to mount a direct T-cell immune attack against tumour cells. |
| List of Excipients |
|---|
|
Tris hydrochloride (2-amino-2-hydroxymethyl-1,3-propanediol hydrochloride) |
10 ml of concentrate in a vial (Type I glass) with a stopper (coated butyl rubber) and a flip-off seal (aluminium). Pack size of 1.
40 ml of concentrate in a vial (Type I glass) with a stopper (coated butyl rubber) and a flip-off seal (aluminium). Pack size of 1.
Not all pack sizes may be marketed.
Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
EU/1/11/698/001-002
Date of first authorisation: 13 July 2011
Date of latest renewal: 21 April 2016
| Drug | Countries | |
|---|---|---|
| YERVOY | Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
