The National Health Surveillance Agency (ANVISA) issued Normative Instruction - IN No. 439 of 16-Apr-2026, updating the list of Brazilian Common Denominations (DCB) with new inclusions and changes. The instruction includes details on specific DCB names and references. It includes the following information:
- This IN 439/2026 enters into force on the date of its publication i.e, on 22-Apr-2026
- The list of DCB approved by IN No. 342, of 20-Dec-2024, is now in force with the inclusions in Annex I, changes in Annex II, of this IN 439/2026
- DCB included in the Annex I are listed below:
- DCB No.12996 : paltusotin hydrochloride
- DCB No.12997 : paltustus
- DCB No.12998 : giredestranto
- DCB No.12999 : giredestrant tartrate
- DCB No.13000 : pegzilarginase
- DCB No.13001 : sigvotatugue vedotina
- DCB No.13002 : pariglasgeno brecparvoveque
- DCB No.13003 : navepegritida
- DCB No.13004 : oveporextona
- DCB No.13005 : palm kernel oil
- DCB No.13006 : rusfertide acetate
- DCB No.13007 : pimavanserin hemitartrate
- DCB No.13008 : pegloticase
- DCB No.13009 : anselaminab
- DCB No.13010 : emapalumab
- DCB changed in the Annex II are listed below:
- DCB No. 04486:
- The Brazilian Common Name remains unchanged (glucose monohydrate)
- The Reference number (CAS Update) is updated (From 14431-43-7 to 77938-63-7)
- The original DCB number is maintained, ensuring continuity in regulatory records
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