SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation
*Company:
Novartis Ireland LimitedStatus:
No Recent UpdateLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 May 2024
File name
SomaKit TOC_REG SPC_PF24-0072_May_clean_IPHA.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to restricted prescription (C)
Updated on 13 May 2024
File name
SomaKitTOC_REG SPC_PF24-0072_K315 AD04-11_TBI 31-Dec-2024.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Updated on 13 May 2024
File name
SomaKit TOC_REG PIL_PF24-0072_May2024_clean_IPHA.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 03 October 2023
File name
SomaKit TOC_REG PIL_PF23-0150_28.09.2023_clean_IPHA.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 22 February 2023
File name
SomaKit TOC_REG PIL_PF23-0043_13.02.2023_clean_IPHA.pdf
Reasons for updating
- Change to MA holder contact details
Updated on 22 February 2023
File name
SomaKit TOC_REG SPC_PF23-0043_13.02.2023_clean_IPHA.pdf
Reasons for updating
- Change to MA holder contact details
Legal category:Product subject to restricted prescription (C)
Updated on 27 September 2022
File name
SomaKit TOC_REG PIL_PF22-0136_19.09.2022_clean_IPHA.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 27 September 2022
File name
SomaKit TOC_REG SPC_PF22-0136_19.09.2022_clean_IPHA.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to restricted prescription (C)
Updated on 23 November 2021
File name
SomaKit_REG SPC_PF21-0244_12.11.2021_clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Removal of Black Inverted Triangle
- Other
Legal category:Product subject to restricted prescription (C)
Updated on 23 November 2021
File name
SomaKit_REG PIL_PF21-0244_12.11.2021_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to MA holder contact details
- Removal of Black Inverted Triangle
Updated on 19 October 2021
File name
SomaKit_REG SPC_PF21-0245_16.09.2021_clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Updated on 19 October 2021
File name
SomaKit_REG PIL_PF21-0245_16.09.2021_clean_TBI 16.03.2022.pdf
Reasons for updating
- New PIL for new product