Isoket 1 mg/ml Concentrate for solution for injection or infusion, 10 ml Ampoule
*Company:
MERUS LabsStatus:
No Recent UpdateLegal 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