##  [Regulation: ANVISA Redefines Petition Codes for Package Inserts, Labels, and Names of Biological and Radiopharmaceutical Products](/index%2ephp/mandate/regulation-anvisa-redefines-petition-codes-for-package-inserts-labels-and-names-of-biological-and-radiopharmaceutical-products) 

April 16, 2026

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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Source

<https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa>

[https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-redefine-c…](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-redefine-codigos-de-peticao-para-bulas-rotulagens-e-nomes-de-produtos-biologicos-e-radiofarmacos)

 

 

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