Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement:

  • in adult and paediatric patients from 2 years of age as an adjunct to general anaesthesia to facilitate tracheal intubation during routine sequence induction and to provide skeletal muscle relaxation during surgery.
  • in adults to facilitate tracheal intubation during rapid sequence induction and as an adjunct in the intensive care unit (ICU) to facilitate intubation and mechanical ventilation for short term use.

No clinical added value of ROCURONIUM AGUETTANT 10 mg/ml solution for injection in pre-filled syringe compared to the other medicinal products already available.


Clinical Benefit

Substantial

The Committee considers that the clinical benefit of ROCURONIUM AGUETTANT 10 mg/ml solution for injection in pre-filled syringe is substantial in the MA indications.


Clinical Added Value

no clinical added value

This medicinal product is a hybrid that does not provide any clinical added value (CAV V) compared to the forms already listed.