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monographed products

Spanish translation: productos homologados (monografiados)

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:monographed products
Spanish translation:productos homologados (monografiados)
Entered by: trnet

22:50 Oct 18, 2007
English to Spanish translations [PRO]
Law/Patents - Medical: Pharmaceuticals
English term or phrase: monographed products
"...is used in cosmetic products marketed in Europe (e.g. NNNN manufactured by XXXX), as well as in a large number of sunscreen products marketed in the USA as ***MONOGRAPHED PRODUCTS*** (e.g. YYYY, manufactured by ZZZZ)."

Creí que se refería a los productos que se envasan con logos de otras empresas (a modo de regalo empresarial), pero veo que la expresión se relaciona con las regulaciones en cosmética y farmacéutica.

¿Alguien sabe?
Gabriel Csaba
Argentina
Local time: 05:37
productos homologados
Explanation:
In pharma as well as cosmetics, there are product monographs issued when a product is authorised or has some sort of authoritative approval. The original formulation may be manufactured under licence by a number of different companies and all of them will refer back to the product licence issued and formulation held by the licence owner.
Selected response from:

trnet
Local time: 09:37
Grading comment
Gracias!
4 KudoZ points were awarded for this answer



Summary of answers provided
5 +2productos homologados
trnet
3 +2productos en monografía/monografiados
Rodarte


Discussion entries: 1





  

Answers


11 mins   confidence: Answerer confidence 5/5 peer agreement (net): +2
productos homologados


Explanation:
In pharma as well as cosmetics, there are product monographs issued when a product is authorised or has some sort of authoritative approval. The original formulation may be manufactured under licence by a number of different companies and all of them will refer back to the product licence issued and formulation held by the licence owner.

trnet
Local time: 09:37
Specializes in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 28
Grading comment
Gracias!

Peer comments on this answer (and responses from the answerer)
agree  Tomás Cano Binder, BA, CT: Sí, eso pienso yo. No he tenido tiempo de mirar cómo le llama en España a esto la Agencia Nacional del Medicamento. Quizá sea "registrados". ¿Sabes tú cómo le llaman?
29 mins
  -> Gracias. La EMEA europea los llama en inglés "Authorised Products" por haber pasado por un proceso muy largo y minucioso de "Marketing Authorisation" que desemboca en la monografía oficial. Tienen un registro oficial de productos homologados y numerados.
agree  Carolina Ruiz
4 hrs
  -> gracias
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4 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
productos en monografía/monografiados


Explanation:
La US Farmacopea les llama monografías a las fichas descriptivas de los productos farmacéuticos usados para establecer estándares públicos.

Espero te ayude

Monografía de acetaminofeno ilustrada
1. Acetaminofeno

C8H9NO2 151.17

Acetamida, N-(4-hidroxifenil)-.
4’-Hidroxiacetanilida [103-90-2].
1. La monografía comienza con un título oficial de acuerdo con lo establecido por los Nombres Adoptados en Estados Unidos (USAN) y según lo descrito en la sección Nomenclatura <1121>. Le siguen una información descriptiva, una fórmula gráfica, una fórmula química, el peso molecular, los nombres químicos y el número de registro CAS (Chemical Abstracts System).


    Reference: http://www.usp.org/USPNF/submitMonograph/
Rodarte
United States
Local time: 03:37
Specializes in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 8

Peer comments on this answer (and responses from the answerer)
agree  Sergio Cortés: Podría ser algo así como "productos que cuentan con monografía"
27 mins
  -> Sergio, tu sugerencia me parece muy acertada.
agree  John Cutler: Buena y muy acertada descripción de las monografías.
7 hrs
  -> John, Gracias
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