Isoket 1 mg/ml Concentrate for solution for injection or infusion, 10 ml Ampoule

  • Company:

    MERUS Labs
  • Status:

    No Recent Update
  • Legal Category:

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

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

Updated on 01 March 2023

File name

ie-pil-isk-10-en-clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 12 January 2023

File name

ie-smpc-isk-10-en-clean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.9 - Overdose
  • Change to section 6.2 - Incompatibilities
  • Change to section 7 - Marketing authorisation holder
  • 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 12 January 2023

File name

ie-pil-isk-10-en-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 18 May 2022

File name

ie-isoket-smpc-en-clean.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 18 May 2022

File name

ie-isoket-pil-en-clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 25 November 2019

File name

ie-smpc-isk-en.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 25 November 2019

File name

ie-pil-isk-en.pdf

Reasons for updating

  • New PIL for new product