For information, the company have advised that they are no longer pursuing a line extension Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) for these indications at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme.
As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes.
| Status | Suspended |
| Decision | Selected |
| Process | TA |
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 07 August 2023 | Suspended. For information, the company have advised that they are no longer pursuing a line extension Marketing Authorisation Application from the Medicines and Healthcare products Regulatory Agency (MHRA) for these indications at this time. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties if the situation changes. |
| 15 July 2022 | Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early July 2023 when we will write to stakeholders about how they can get involved. The deadline for submissions is expected in approximately early September 2023. |
For further information on our processes and methods, please see our CHTE processes and methods manual