GIVLAARI Solution for injection Ref.[9926] Active ingredients: Givosiran

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Alnylam Netherlands B.V., Strawinskylaan 3051, 1077 ZX Amsterdam, Netherlands

Product name and form

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).

Qualitative and quantitative composition

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)
Phosphoric acid (pH adjustment)
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

Alnylam Netherlands B.V., Strawinskylaan 3051, 1077 ZX Amsterdam, Netherlands

Marketing authorization dates and numbers

EU/1/20/1428/001

Drugs

Drug Countries
GIVLAARI Austria, Brazil, Canada, Cyprus, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United States

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