Table 1

Steps in the initial evaluation and the re-examination of the marketing authorisation for Ninlaro

Step/procedureDate
Accelerated assessment procedure agreed23 July 2015
Initial marketing authorisation application received30 July 2015
Adoption of the consolidated list of questions by the CHMP17 December 2015
Submission of responses to the consolidated list of questions to the CHMP25 January 2016
Outstanding issues were addressed by the applicant during an oral explanation at the CHMP30 March 2016
The CHMP adopted a negative opinion for granting a marketing authorisation to Ninlaro26 May 2016
The re-examination procedure started21 August 2016
SAG meeting5 September 2016
The CHMP adopted a positive opinion for granting a marketing authorisation to Ninlaro15 September 2016
  • CHMP, Committee for Medicinal Products for Human Use; SAG, Scientific Advisory Group.