Dec 6, 2014 18:02
9 yrs ago
13 viewers *
Portuguese term

cadastrado

Portuguese to English Medical Medical: Pharmaceuticals
Hello, I have a problem in translating "cadastrado" and "registrado" in the same phrase. It refers to drug registration. Can someone help me, please? Thanks a lot.
Proposed translations (English)
5 +4 registered or listed
3 approval
Change log

Dec 6, 2014 18:54: Fernanda Rocha changed "Term asked" from "cadastrado (this case)" to "cadastrado"

Discussion

Mario Freitas Dec 7, 2014:
In that case, I'd go for Verlow's/Carolina's suggestion.
BTW: The standard Context post in KudoZ is: (1) One sentece/segment before the asked-term stretch; (2) The full sentence where the asked-term is found (preferably surrounding the asked-term with "***" before and after); (3) One sentece after that stretch. So the ideal "Context" has at least three sentences. This is not a KudoZ standard, it's a standard developed by the users, that practice has proven to be the best.
Zornitsa Antonova (asker) Dec 7, 2014:
Hello, everyone, thanks for helping. It seems I don't see all comments in the discussion, I don't know why, but for those who asked for context, it's about medicines and I have already provided the phrase I have in a discussion entry - A concessão do registro ou cadastro é tornada pública por meio da sua publicação de deferimento em Diário Oficial da União.
Nick Taylor Dec 7, 2014:
Zornitsa Antonova perhaps you can now appreciate the need to put examples of CONTEXT!
Mario Freitas Dec 7, 2014:
Certo, Carol, Minha observação foi genérica e não se aplica a medicamentos, mesmo porque não sou especialista na área.
Carolina Dagli Dec 7, 2014:
Registro de medicamentos O REGISTRO de medicamento é um processo que se submente à autoridade regulatória (no Brasil, a ANVISA) que resulta na aprovação do medicamento (concessão de registro) no país. Medicamentos sem registro no Brasil não podem ser comercializados. A tradução seria "license".
Já CADASTRO talvez se refira ao cadastro na lista do sistema único de saúde, mas confesso que nunca ouvi falar de cadastro. Acho que uma boa tradução seja a sugerida pelo Verlow, "listed".
Benjamin R Dec 7, 2014:
Enrolled/registered? Impossible to determine correct usage without context. Can you post how both are used in your document?
Mario Freitas Dec 6, 2014:
Registro vs. cadastro Registro se aplica a qualquer inclusão de dados em uma base ou arquivo = Logging, recording. Cadastro refere-se à inclusão em uma relação de pessoas/entidades que ficam autorizadas a realizar alguma atividade = Registration, enrollment.
Portanto, um dado pode ser registrado (gravado na base) sem que a entidade seja cadastrada (autorizada a exercer a atividade-alvo).
Zornitsa Antonova (asker) Dec 6, 2014:
Sure, however, I would like to get some explanation about the difference between both in Portuguese, regardless of the area, because registro and cadastro appear in many different areas.
A concessão do registro ou cadastro é tornada pública por meio da sua publicação de deferimento em Diário Oficial da União
Nick Taylor Dec 6, 2014:
Original sentence please!!!!!! !!!!

Proposed translations

+4
1 hr
Selected

registered or listed

cadastro = registration
registro = license

I have often come across these in my work and I translate as follows:

A licensed [registered] drug can be registered or listed [cadastrado] as a prescription drug or not.

Other examples: -acetyl-para-aminophenol (APAP) is listed/registered in the Brazilian National Generic Drugs Register"; Tylenol is a licensed drug and a registered brand in brazil

In general "cadastrado" is registered as well, but if you must use both in the same sentence, or paragraph, then "listed" and "registered" are just fine.
Peer comment(s):

agree Linda Miranda
2 hrs
agree Carolina Dagli
16 hrs
agree Mario Freitas :
21 hrs
agree Trans_Versa : Excelent explanation by Verlow
21 hrs
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4 KudoZ points awarded for this answer. Comment: "Thank you very much! This is really it. Merry Christmas!"
1 day 22 hrs

approval

Close equivalent; see particularly the first example:

On a quarterly basis, FDA will publish a list of approvals announced during that quarter in the Federal Register. When a notice of approval is published, data and information in the PMA file will be available for public disclosure in accordance with §814.9.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...



The Food and Drug Administration has granted accelerated approval to the drug Keytruda (generic name: pembrolizumab), an injectable drug used to treat patients with melanoma, the deadliest of all skin cancer types.

Salix Pharmaceuticals, Ltd. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Apriso (mesalamine) extended-release capsules 0.375 g.

Previously, the FDA also designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis, mucormycosis and candidiasis under the Generating Antibiotic Incentives Now (GAIN) Act. QIDP status provides priority review and a five-year extension of market exclusivity if the drug receives approval in the US.

Patents can be expired before drug approval, issued after drug approval, and anywhere in between. Exclusivity is granted upon approval of a drug product if the statutory requirements are met. Some drugs have both patent and exclusivity protection while others have just one or none.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm07903...

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