1. Amendments to the Poison Standard in relation to New Chemical Entities (NCEs)
The NCEs listed below will be included in the new Poisons Standard that will come into effect on 1 October 2021.
Note
New text is shown as green, larger font, with a horizontal line above it.
1.1. Amifampridine
Recommendation
Schedule 4 - New Entry
AMIFAMPRIDINE.
Index - New Entry
AMIFAMPRIDINE
Schedule 4
Date of effect
1 October 2021
1.2. Belumosudil
Recommendation
Schedule 4 - New Entry
BELUMOSUDIL.
Appendix L - New Entry
BELUMOSUDIL.
Warning statements: 62 (Do not use if pregnant), 77(WARNING - May cause birth defects)
Index - New Entry
BELUMOSUDIL
Schedule 4
Appendix L
Date of effect
1 October 2021
1.3. Estetrol monohydrate
Recommendation
Schedule 4 - New Entry
ESTETROL MONOHYDRATE.
Index - New Entry
ESTETROL MONOHYDRATE
Schedule 4
Date of effect
1 October 2021
1.4. Finerenone
Recommendation
Schedule 4 - New Entry
FINERENONE.
Appendix L - New Entry
FINERENONE.
Warning statements: 67 (Do not use if pregnant or likely to become pregnant), 111 (Do not use if breastfeeding or planning to breastfeed).
Index - New Entry
FINERENONE
Schedule 4
Appendix L
Date of effect
1 October 2021
1.5. Fostemsavir
Recommendation
Schedule 4 - New Entry
FOSTEMSAVIR.
Index - New Entry
FOSTEMSAVIR
Schedule 4
Date of effect
1 October 2021
1.6. Inclisiran
Recommendation
Schedule 4 - New Entry
INCLISIRAN.
Index - New Entry
INCLISIRAN
Schedule 4
Date of effect
1 October 2021
1.7. Pegcetacoplan
Recommendation
Schedule 4 - New Entry
PEGCETACOPLAN.
Index - New Entry
PEGCETACOPLAN
Schedule 4
Date of effect
1 October 2021
1.8. Pegvaliase
Recommendation
Schedule 4 - New Entry
PEGVALIASE.
Index - New Entry
PEGVALIASE
Schedule 4
Date of effect
1 October 2021
1.9. Sacituzumab govitecan
Recommendation
Schedule 4 - New Entry
SACITUZUMAB GOVITECAN.
Index - New Entry
SACITUZUMAB GOVITECAN
Schedule 4
Date of effect
1 October 2021
1.10. Sotrovimab
Recommendation
Schedule 4 - New Entry
SOTROVIMAB.
Index - New Entry
SOTROVIMAB
Schedule 4
Date of effect
1 October 2021
1.11. Trastuzumab deruxtecan
Recommendation
Schedule 4 - New Entry
TRASTUZUMAB DERUXTECAN.
Appendix L - New Entry
TRASTUZUMAB DERUXTECAN.
Warning statements: 62 (Do not use if pregnant), 77(WARNING - May cause birth defects)
Index - New Entry
TRASTUZUMAB DERUXTECAN
Schedule 4
Appendix L
Date of effect
1 October 2021
1.12. Vericiguat
Recommendation
Schedule 4 - New Entry
VERICIGUAT.
Index - New Entry
VERICIGUAT
Schedule 4
Date of effect
1 October 2021
1.13. Zanubrutinib
Recommendation
Schedule 4 - New Entry
ZANUBRUTINIB.
Index - New Entry
ZANUBRUTINIB
Schedule 4
Date of effect
1 October 2021