CMDh mandated the SWP/NcWP for AI derivations of N-nitrosamines

pragnesh · August 16, 2022, 11:14am

CMDh - Nitrosamine updates.pdf (27.2 KB)

Diego_HM · August 16, 2022, 2:22pm

Hi Pragnesh,

Thank for the info, may we have a direct link from EMA to the information please? This is major information.

Edit 1: I think the information is indicated in several documents. I have found for the moment the following ones

PROM Agenda 10 May 2022 (europa.eu)

PROM Agenda 13 June 2022 (europa.eu)

pragnesh · August 16, 2022, 5:01pm

You are right…the information is collected from recent multiple EMA PROM meetings minutes…so there is no single link. Hope this answers your query…

Diego_HM · June 9, 2023, 2:13pm

Hi all, recently EMA updated its webpage with new minutes from the PROM meetings from January to April. This meetings gives information on nitrosamines that have been actually detected from a MAH.

Worth once in a while to check it ;).

pragnesh · June 9, 2023, 8:31pm

Thank you @Diego_HM for the update

It looks total 24 NDSRIs all together…

• N-nitroso-2,6-pipecoloxilidide
• N-nitroso-valaciclovir (impurity C)
• N-nitroso-2-isopropyl-5,5 dimethyl thiazolidine-4 carboxylic acid (NIPDMTC)
• N-nitroso-desmethyl-terbinafine (NDT)
• N-nitroso-terbinafine impurity A (NTA)
• N-nitroso-terbinafine degradant (NTD)
• N-nitroso-tamsulosin
• 2-(4-nitrosopiperazine-1-yl)-pyrimidine
• N-nitroso-piperazine
• N-nitroso-clonidine
• N-nitroso-enalapril
• N-nitroso-cilazapril
• N-nitroso-ketamine
• N-nitroso-atomoxetine
• N-nitroso-atenolol
• N-nitroso-desmethyl-tripelennamine
• N-nitroso-p-chloro-benzylamino-pyridine
• N-nitroso-desmethyl-chloropyramine
• N-nitroso-desmethylazithromycin
• N-nitroso-vildagliptin
• N-nitroso-perindopril
• N-nitroso-labetalol
• N-nitroso-benazepril
• N-nitroso-lisinopril

With this new list of NDSRIs, NcWP will be busy for a while…

Yosukemino · June 10, 2023, 5:33am

Thank you, @Diego_HM and @pragnesh. It’s interesting. I excerpt the nitrosamine part from the agenda. It may be helpful to understand their surroundings.

PROM Agenda 11 July 2022 (europa.eu)