Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Alnylam Netherlands B.V., Strawinskylaan 3051, 1077 ZX Amsterdam, Netherlands
Givlaari 189 mg/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. Clear, colourless to yellow solution (pH of approximately 7.0; osmolality: 275-295 mOsm/kg). |
Each mL of solution contains givosiran sodium equivalent to 189 mg givosiran.
Each vial contains 189 mg givosiran.
Excipients with known effect: For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Givosiran |
Givosiran is a double-stranded small interfering ribonucleic acid (siRNA) that causes degradation of aminolevulinic acid synthase 1 (ALAS1) messenger ribonucleic acid (mRNA) in hepatocytes through RNA interference, resulting in a reduction of induced liver ALAS1 mRNA towards normal. This leads to reduced circulating levels of neurotoxic intermediates aminolevulinic acid (ALA) and porphobilinogen (PBG), the key causal factors of attacks and other disease manifestations of AHP. |
| List of Excipients |
|---|
|
Sodium hydroxide (pH adjustment) |
Glass vial with a PTFE-coated chlorobutyl rubber stopper and a flip-off aluminium seal. Each vial contains 1 mL solution for injection.
Pack size of one vial.
Alnylam Netherlands B.V., Strawinskylaan 3051, 1077 ZX Amsterdam, Netherlands
EU/1/20/1428/001
| Drug | Countries | |
|---|---|---|
| GIVLAARI | Austria, Brazil, Canada, Cyprus, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United States |
© 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.
