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  3. Medical: Pharmaceuticals

SOB

Russian translation: особые обязательства

04:09 Jul 4, 2020
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals / PRAC PSUR assessment repo
English term or phrase: SOB
This report on Trisenox® (arsenic trioxide or ATO) summarizes all the safety information received from worldwide sources by subsidiaries of Teva Group and licence partners from 01st October 2014 to 30th September 2017.
It is the 15th Periodic Safety Update Report (PSUR).
Trisenox® (arsenic trioxide or ATO), a trivalent inorganic arsenical formulated as a sterile injectable solution, was first approved in USA on 25th September 2000.
Marketing Authorization under exceptional circumstances was granted in the European Union on 5th March 2002, via centralized procedure.
Following SOBs completion, full MA was granted on 10 Aug 2010.
It was originally designated an orphan medicine on 18 October 2000.
Trisenox was withdrawn from the Community register of orphan medicinal products in March 2012 at the end of the 10-year period of market exclusivity.
Julia Berezina
Local time: 09:29
Russian translation:особые обязательства
Explanation:
SOBs = specific obligations

Specific obligations can only be imposed on marketing authorisations granted under exceptional circumstances or on conditional marketing authorisations (see also questions on 'Is my medicinal product eligible for approval under exceptional circumstances ?' and 'Could my application qualify for a conditional marketing authorisation?' of the Agency's presubmission guidance). These are conditions to the marketing authorisation included in annex II.E of the Commission decision and form the basis of the annual re-assessment or the annual renewal. These may also be additional Pharmacovigilance activity and will be included as well in the RMP (category 2 studies).
Selected response from:

Tetiana Tkachenko
Ukraine
Local time: 09:29
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
3особые обязательства
Tetiana Tkachenko


  

Answers


2 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
sob
особые обязательства


Explanation:
SOBs = specific obligations

Specific obligations can only be imposed on marketing authorisations granted under exceptional circumstances or on conditional marketing authorisations (see also questions on 'Is my medicinal product eligible for approval under exceptional circumstances ?' and 'Could my application qualify for a conditional marketing authorisation?' of the Agency's presubmission guidance). These are conditions to the marketing authorisation included in annex II.E of the Commission decision and form the basis of the annual re-assessment or the annual renewal. These may also be additional Pharmacovigilance activity and will be included as well in the RMP (category 2 studies).


    https://www.ema.europa.eu/en/human-regulatory/post-authorisation/post-authorisation-measures-questions-answers
    https://www.ema.europa.eu/en/documents/presentation/presentation-legal-basis-types-approvals-s-prilla_en.pdf
Tetiana Tkachenko
Ukraine
Local time: 09:29
Specializes in field
Native speaker of: Native in RussianRussian, Native in UkrainianUkrainian
PRO pts in category: 27
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