This medicine is authorised for use in the European Union.


Tyruko is a medicine used in adults to treat highly active multiple sclerosis (MS) that is rapidly getting worse or that is not sufficiently controlled with at least one other disease-modifying therapy (a therapy that can modify the course of the disease).

MS is a disease of the nerves, in which inflammation destroys the protective sheath surrounding nerves and damages the nerves themselves.

Tyruko is used in relapsing-remitting MS, a type of MS in which the patient has attacks (relapses) between periods of stable symptoms (remissions).

Tyruko is a ‘biosimilar medicine’. This means that Tyruko is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Tyruko is Tysabri. For more information on biosimilar medicines, see here.

Tyruko contains the active substance natalizumab.

This EPAR was last updated on 20/11/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Multiple Sclerosis, Relapsing-Remitting
  • Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Sandoz GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Biochemiestrasse 10
6250 Kundl

Product information

30/10/2023 Tyruko - EMEA/H/C/005752 - IAIN/0001

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups:

Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1)
Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.

Assessment history

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