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