Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement of the range supplement VENTOLIN (salbutamol) 0.5 mg/1 ml solution for subcutaneous injection in ampoules packaged in packs of 5 ampoules in the MA indication, i.e.: “Symptomatic treatment of acute asthma in adults by subcutaneous injection”.

No clinical added value of the new form (pack of 5 ampoules) compared to the form already available (pack of 6 ampoules).


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of VENTOLIN (salbutamol) 0.5 mg/1 ml solution for subcutaneous injection in ampoules in a pack of 5 is substantial in the MA indication.


Clinical Added Value

no clinical added value

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


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