EMEA/H/C/00528/II/0084

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06:02 Jul 6, 2018
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals / клинические испытания
English term or phrase: EMEA/H/C/00528/II/0084
During the reporting period, the insulin detemir RMP was first updated from Version 17 to 18 in connection with EMEA/H/C/00528/II/0084 (post-approval commitment for Levemir® in the EU and Australia: a separate report based on descriptive statistics on the incidence of neoplasms with the combination of liraglutide and insulin [including insulin detemir]).
Tymur Buliekov
Ukraine
Local time: 15:33


Summary of answers provided
5 +1ПОБЛС № EMEA/H/C/00528/II/0084
Natalie
4 -1реестр...
Stanislav Korobov


  

Answers


10 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): -1
emea/h/c/00528/ii/0084
реестр...


Explanation:
И дальше - вот всё то, что вынесено в вопрос

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Note added at 22 mins (2018-07-06 06:24:37 GMT)
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Если ещё точнее, то можно, например, "запись" или "информация" (в реестре), так как цифры, стоящие в конце - это номер в этом реестре, относящийся к последним опубликованым данным о препаратеhttps://clinicaldata.ema.europa.eu/web/cdp/home

Stanislav Korobov
Ukraine
Local time: 15:33
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 1075

Peer comments on this answer (and responses from the answerer)
disagree  Natalie: Это не реестр
2 hrs
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2 hrs   confidence: Answerer confidence 5/5 peer agreement (net): +1
emea/h/c/00528/ii/0084
ПОБЛС № EMEA/H/C/00528/II/0084


Explanation:
Это номер обозначает номер PSUR (по-русски ПОБЛC - периодически обновляемый отчет по безопасности лекарственного средства) для препарата детемир/левемир (названия в зависимости от страны). Часть номера EMEA/H/C/00528 - это номер препарата, а все вместе - номер пост-маркетингового отчета ПОБЛС.

Вот сведения об этом отчете:
15.3.23. Insulin detemir - LEVEMIR (CAP) - EMEA/H/C/000528/II/0084
Applicant: Novo Nordisk A/S
PRAC Rapporteur: Doris Stenver
Scope: Submission of the summary analysis report on the incidence of neoplasms with the combination of liraglutide and insulin detemir from the cardiovascular outcome trial for Victoza (liraglutide): study EX2211-3748 (LEADER: liraglutide effect and action in diabetes): a long-term, multicentre, international, randomized double-blind, placebo-controlled trial to
determine liraglutide effects on cardiovascular events. The RMP (version 18) is updated accordingly to delete the important potential risk of malignant neoplasms following combination treatment with insulin detemir, liraglutide and metformin
(стр. 72-73)
https://tinyurl.com/y8x6rs77


Natalie
Poland
Local time: 14:33
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 8905

Peer comments on this answer (and responses from the answerer)
agree  Erzsébet Czopyk: excellent. Congrats Natalie
9 hrs
  -> Спасибо!
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