On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Shingrix, intended for prophylaxis of herpes zoster. The applicant for this medicinal product is GlaxoSmithkline Biologicals SA.
Shingrix will be available as a powder and suspension liquid to be made into a suspension for injection. The active substance of Shingrix is varicella zoster virus glycoprotein E antigen (VZV gE) (ATC code: J07BK03). In Shingrix, VZV gE is combined with an adjuvant (AS01B), and is designed to induce antigen-specific cellular and humoral immune responses in individuals with pre-existing immunity against varicella zoster virus.
The benefits with Shingrix are its ability to significantly decrease the incidence of herpes zoster and consequently of post-herpetic neuralgia compared with placebo. The most common side effects are pain at the injection site, myalgia, fatigue and headache.
The full indication is: “Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in adults 50 years of age or older. The use of Shingrix should be in accordance with official recommendations”.
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