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Pombiliti 105 mg powder for concentrate for solution for infusion

Licence status
Authorised: 20/03/2023
Active substances
Cipaglucosidase alfa
Dosage Form
Powder for concentrate for solution for injection/infusion
Licence number
EU/1/22/1714/001-003
Licence holder
Amicus Therapeutics Europe Limited

Licence information

ATC code
A16AB Enzymes, A16AB23 cipaglucosidase alfa
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
20/03/2023