Enspryng 120 mg solution for injection in pre-filled syringe *

  • Company:

    Roche Registration GmbH
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    This medicinal product is subject to additional monitoring.

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

EDM Updated on 30 September 2021

File name

Satralizumab Patient Alert Card IE Version 2.0.1 (2)_1633007840.pdf

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

The patient alert card is aimed at intensifying the communication around the risk of infections/serious infections, to ensure that patients seek early medical attention in case of signs and symptoms of infections to facilitate timely diagnosis of infections, and that the healthcare professionals are aware of the need for timely and appropriate measures.

Updated on 09 August 2021

File name

Irish PIL Enspryng_V2.0_IB-0001_26 Jul 2021_1628501758.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 August 2021

File name

Irish SPC Enspryng_V2.0_IB-0001_26 Jul 2021_1628501556.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 01 July 2021

File name

Enspryng_SmPC_MAA_24-Jun-2021_Clean_1625136533.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)