GLYBERA Solution for injection Ref.[27946] Active ingredients: Alipogene tiparvovec

Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands

Product name and form

Glybera 3 × 10¹² genome copies/ml solution for injection.

Pharmaceutical Form
Solution for injection. Clear, to slightly opalescent, colourless solution.

Qualitative and quantitative composition

Alipogene tiparvovec contains the human lipoprotein lipase (LPL) gene variant LPL^S447X in a vector. The vector comprises a protein shell derived from adeno-associated virus serotype 1 (AAV1), the Cytomegalovirus (CMV) promoter, a woodchuck hepatitis virus posttranscriptional regulatory element and AAV2 derived inverted terminal repeats. Alipogene tiparvovec is produced using insect cells and recombinant baculovirus technology.

Each vial of alipogene tiparvovec contains 1 extractable ml of solution, containing 3 × 10¹² genome copies (gc).

Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 × 10¹² LPL^S447X gc/kg bodyweight.

Excipient with known effect: This medicinal product contains 47.5 mg sodium per administration at 27 injection sites to 105.6 mg sodium per administration at 60 injection sites.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Alipogene tiparvovec	Alipogene tiparvovec contains the human lipoprotein lipase (LPL) gene variant LPL^S447X in a vector. The human LPL gene variant LPL^S447X in an adeno-associated virus serotype 1 (AAV1) vector intended to target the muscle. Alipogene tiparvovec is injected as a one-time series into the muscle of the lower extremities where it is taken up by myocytes.

List of Excipients
Disodium phosphate anhydrous Potassium chloride Potassium dihydrogen phosphate Sodium chloride Sucrose Water for injections

Pack sizes and marketing

1 ml solution in a 2 ml vial (glass) with siliconised chlorobutyl, injection stopper and flip-off seal.

Each preformed transparent sealed plastic casing contains either 2 or 3 individual vials with a liquid absorbing sheet. The final outer carton contains a variable number of casings according to the patient specific dose required.

Marketing authorization holder

uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands

Marketing authorization dates and numbers

EU/1/12/791/001

Date of first authorisation: 25 October 2012

Drugs

Drug	Countries
GLYBERA	Estonia, Lithuania

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