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  3. Medical: Pharmaceuticals

class issue

Italian translation: un problema che interessa/coinvolge/riguarda tutti i medicinali della stessa classe

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:class issue
Italian translation:un problema che interessa/coinvolge/riguarda tutti i medicinali della stessa classe
Entered by: Mario Altare

11:18 Feb 28, 2017
English to Italian translations [PRO]
Medical - Medical: Pharmaceuticals / canagliflozin
English term or phrase: class issue
The European Commission (EC) triggered a procedure under Article 20 of Regulation (EC) No 726/2004 on 15 April 2016; the PRAC (Pharmacovigilance Risk Assessment Committee) was requested to assess the impact on the benefit-risk balance of canagliflozin containing medicinal products, to assess whether this is a ** class issue ** and to issue a recommendation by 31 March 2017 on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked and whether provisional measures are necessary to ensure the safe and effective use of these medicinal products.
Mario Altare
Local time: 14:33
un problema che interessa a tutti i medicinali della stessa classe
Explanation:
Questa è la mia interpretazione.

"The review of canagliflozin was initiated at the request of the European Commission on 15 April 2016, under Article 20 of Regulation (EC) No 726/2004. The review was extended to include the other medicines in the same class, dapagliflozin and empagliflozin, on 7 July 2016."

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Note added at 4 ore (2017-02-28 16:02:15 GMT)
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Correzione: un problema che interessa/coinvolge tutti i medicinali della stessa classe
Selected response from:

Patricia Ferreira Larrieux
Italy
Local time: 14:33
Grading comment
Grazie mille (anche a Martini) :-)
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1un problema che interessa a tutti i medicinali della stessa classe
Patricia Ferreira Larrieux
3problema / problematica in termini di classe di medicinali
martini


  

Answers


4 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
un problema che interessa a tutti i medicinali della stessa classe


Explanation:
Questa è la mia interpretazione.

"The review of canagliflozin was initiated at the request of the European Commission on 15 April 2016, under Article 20 of Regulation (EC) No 726/2004. The review was extended to include the other medicines in the same class, dapagliflozin and empagliflozin, on 7 July 2016."

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Note added at 4 ore (2017-02-28 16:02:15 GMT)
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Correzione: un problema che interessa/coinvolge tutti i medicinali della stessa classe


    Reference: http://www.ema.europa.eu/docs/en_GB/document_library/Referra...
Patricia Ferreira Larrieux
Italy
Local time: 14:33
Specializes in field
Native speaker of: Native in SpanishSpanish, Native in ItalianItalian
PRO pts in category: 12
Grading comment
Grazie mille (anche a Martini) :-)

Peer comments on this answer (and responses from the answerer)
neutral  martini: beh, la tua è solo una formulazione più lunga, tra l'altro ho riportato anche la frase "riguardare anche gli altri medicinali della stessa classe" ma ho cercato un'espressione più breve
3 hrs
agree  Kreonia
1 day 6 hrs
Login to enter a peer comment (or grade)

26 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
problema / problematica in termini di classe di medicinali


Explanation:
proposta in base al seg. documento

Il PRAC conclude che il medicinale antidiabetico
canagliflozin può contribuire al rischio di amputazione
delle dita del piede Il rischio potrebbe riguardare anche gli altri medicinali della stessa classe
.....
La revisione di canaglifozin è stata avviata su richiesta della Commissione Europea il 15 aprile 2016 sulla base dell’articolo 20 del Regolamento n. 726/2004. La revisione è stata estesa il 7 luglio 2016 per includere gli altri medicinali della stessa classe, dapagliflozin ed empagliflozin.

http://www.farmacovigilanza.asl3.liguria.it/pdf/aifa/SGLT2_I...

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Note added at 2 days5 hrs (2017-03-02 16:48:22 GMT) Post-grading
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prego, Mario, ma sono delusa

martini
Italy
Local time: 14:33
Native speaker of: Italian
PRO pts in category: 31
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