AIMOVIG Solution for injection Ref.[8685] Active ingredients: Erenumab

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Aimovig 70 mg solution for injection in pre-filled syringe.
Aimovig 140 mg solution for injection in pre-filled syringe.
Aimovig 70 mg solution for injection in pre-filled pen.
Aimovig 140 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

The solution is clear to opalescent, colourless to light yellow.

Qualitative and quantitative composition

Aimovig 70 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 70 mg erenumab.

Aimovig 140 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains 140 mg erenumab.

Aimovig 70 mg solution for injection in pre-filled pen: Each pre-filled pen contains 70 mg erenumab.

Aimovig 140 mg solution for injection in pre-filled pen: Each pre-filled pen contains 140 mg erenumab.

Erenumab is a fully human IgG2 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Erenumab

Erenumab is a human monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor. CGRP is a neuropeptide that modulates nociceptive signalling and a vasodilator that has been associated with migraine pathophysiology. Inhibition of the effects of CGRP could theoretically attenuate compensatory vasodilation in ischaemic-related conditions.

List of Excipients

Sucrose
Polysorbate 80
Sodium hydroxide (for pH adjustment)
Glacial acetic acid
Water for injections

Pack sizes and marketing

Pre-filled syringe:

Aimovig is supplied in a pre-filled syringe (1 ml, Type 1 glass) with a stainless steel needle and a needle cover (rubber containing latex).

Aimovig is available in packs containing 1 pre-filled syringe.

Pre-filled pen:

Aimovig is supplied in a pre-filled pen (1 ml, Type 1 glass) with a stainless steel needle and a needle cover (rubber containing latex).

Aimovig is available in packs containing 1 pre-filled pen and in multipacks containing 3 (3x1) pre-filled pens.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/18/1293/001-006

26 July 2018

Drugs

Drug Countries
AIMOVIG Austria, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, New Zealand, Poland, Romania, Singapore, United Kingdom, 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.