Spexotras 0.05 mg / ml powder for oral solution

Licence status
Authorised: 05/01/2024
Active substances
Trametinib dimethyl sulfoxide
Dosage Form
Powder for oral solution
Licence number
EU/1/23/1781/001
Licence holder
Novartis Europharm Limited

Product documents

Licence information

ATC code
L01EE01 trametinib
Legal supply status
Product subject to prescription which may not be renewed (A)
Place of sale
Supply through pharmacies only
Conditions of Licence
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing availability
Unknown
Advertising conditions
Advertising to healthcare professionals only
Licence issued
05/01/2024