ELELYSO (taliglucerase alfa) for injection

Elelyso contains the active ingredient taliglucerase alfa rpc and is an Enzyme Replacement Therapy which is used to treat Type 1 Gaucher disease in adults and children (2 to 17 years of age)

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ELELYSO (taliglucerase alfa) for injection Price In India Ahmedabad Bengaluru Chennai Kolkata Mumbai
ELELYSO (taliglucerase alfa) for injection

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ELELYSO (taliglucerase alfa) for injection

Taliglucerase alfa injection is used for the long-term treatment of type 1 Gaucher disease. This disease is caused by the lack of a certain enzyme in the body called glucocerebrosidase.

ELELYSO (taliglucerase alfa) for injection is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO (taliglucerase alfa) for injection, for intravenous use Initial US Approval: 2012

Taliglucerase alfa, is a biopharmaceutical medication developed by Protalix and Pfizer. The drug, a recombinant glucocerebrosidase used to treat Gaucher’s disease, is the first plant-made pharmaceutical to win approval by the U.S. Food and Drug Administration (FDA). Each vial has 200 units of taliglucerase alfa.

The U.S. FDA New Drug Application (NDA) was granted approval in May 2012, for use in adults. The U.S. FDA Supplemental New Drug Application (sNDA) for pediatric use was granted approved in August 2014. In Israel, the Israeli Ministry of Health granted approval in September 2012. In Brazil, the Brazilian Health Surveillance Agency (ANVISA) granted approval in March 2013. In Canada, Health Canada issued a Notice of Compliance in May 2014, for both adults and pediatric patients.

Drug (Brand / Generic): ELELYSO / taliglucerase alfa
Current Indication: treat Type 1 Gaucher disease
Approval Date: Aug 1, 2012

Pfizer Inc
For injection: lyophilized powder for reconstitution with diluent
• Available in 200 Unit single-use vials

ELELYSO™ is available as a lyophilized powder, 200 Units per vial (NDC 0069 0106 01).
Store ELELYSO at 2 to 8°C (36 to 46°F). Protect vials from light.

For more highlights of prescribing information regarding Indications and usage, dosage and administration, dosage forms and strengths, patient counseling information and medication guide. Click Here

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