AJOVY Solution for injection Ref.[8745] Active ingredients: Fremanezumab

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: TEVA GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany

Product name and form

AJOVY 225 mg solution for injection in pre-filled syringe.

AJOVY 225 mg solution for injection in pre-filled pen.

Pharmaceutical Form

Solution for injection (injection).

Clear to opalescent, colourless to slightly yellow solution with a pH of 5.5 and an osmolality of 300-450 mOsm/kg.

Qualitative and quantitative composition

One pre-filled syringe contains 225 mg fremanezumab.

One pre-filled pen contains 225 mg fremanezumab.

Fremanezumab is a humanised monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fremanezumab

Fremanezumab is a humanised IgG2Δa/kappa monoclonal antibody which selectively binds the calcitonin gene-related peptide (CGRP) ligand and blocks both CGRP isoforms (α- and β-CGRP) from binding to the CGRP receptor. It is believed that prevention of migraine is obtained by its effect modulating the trigeminal system.

List of Excipients

L-histidine
L-histidine hydrochloride monohydrate
Sucrose
Disodium ethylenediaminetetraacetic acid (EDTA) dihydrate
Polysorbate 80 (E433)
Water for injections

Pack sizes and marketing

Pre-filled syringe: 1.5 mL solution in a 2.25 mL Type I glass syringe with plunger stopper (bromobutyl rubber) and needle.

Pack sizes of 1 or 3 pre-filled syringes. Not all pack sizes may be marketed.

Pre-filled pen: Pre-filled pen containing 1.5 mL solution in a 2.25 mL Type I glass syringe with plunger stopper (bromobutyl rubber) and needle.

Pack sizes of 1 or 3 pre-filled pens. Not all pack sizes may be marketed.

Marketing authorization holder

TEVA GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany

Marketing authorization dates and numbers

Pre-filled syringe:

EU/1/19/1358/001 – 1 pre-filled syringe
EU/1/19/1358/002 – 3 pre-filled syringes

Pre-filled pen:

EU/1/19/1358/003 – 1 pre-filled pen
EU/1/19/1358/004 – 3 pre-filled pens

Date of first authorisation: 28 March 2019

Drugs

Drug Countries
AJOVY Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa

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