Sentence examples for conditional authorisation from inspiring English sources

On November 22, 2013, the EMA recommended conditional authorisation of delamanid (Deltyba; Otsuka Novel Products, Wexham, UK) for use in combination with other medicines against MDR/XDR-TB, when an effective treatment regimen cannot otherwise be devised for reasons of resistance or tolerability [ 170].

On December 19 , 2013 the EMA has adopted a positive opinion, recommending granting a conditional marketing authorisation for bedaquiline (Sirturo; Janssen Therapeutics, Titusville, NJ, USA) for the treatment of MDR/XDR-TB.

Olaratumab, manufactured by US-based pharmacompanyl company Eli Lilly, had received a conditional marketing authorisation, subject to further clinical trial results.

PAMs are especially imposed on conditional marketing authorisations or when marketing authorisations have been granted under exceptional circumstances.

Several instruments exist to enable innovative products to be made available more quickly: temporary use authorisations, which are not concerned by this work (ATUs), conditional marketing authorisations (MAs) and MAs under exceptional circumstances.

Shadow foreign secretary Douglas Alexander said Labour's support for future action in Syria would not be conditional on UN authorisation as, alluding to possible vetoes by China and Russia, "the UK's moral compass is not set in Moscow and Beijing".

(The conditional is a condition.

(26) Authorisation of a CCP should be conditional on a minimum amount of initial capital.

EMA: European Medicines Agency; EPAR: European Public Assessment Report; G-BA: Federal Joint Committee PAMM: post-authorisation measure Table 1 List of products with conditional appraisalsa and/or PAMsb Product Brand name Indication Conditional appraisalsd PAMse y/n Time frame (years) Number Time frame (years) Aclidinium bromide Eklira Genuair/Bretaris Genuair COPD No - 1 n.a.a

The aim of this study was to compare post-authorisation measures (PAMs) from the European Medicines Agency EMAA) with data requests in fixed-termed conditional appraisals of early benefit assessments from the German Federal Joint Committee (G-BA).

63 First, Article 2 e) of the Conditional Access Directive defines 'illicit device' as any equipment or software 'designed' or 'adapted' to give access to a protected service in an intelligible form without the authorisation of the service provider.