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KALYDECO

50 Milligram Granules

Vertex Pharmaceuticals (U.K.) LimitedEU/1/12/782/003

Main Information

Trade NameKALYDECO
Active SubstancesIVACAFTOR
Strength50 Milligram
Dosage FormGranules
Licence HolderVertex Pharmaceuticals (U.K.) Limited
Licence NumberEU/1/12/782/003

Group Information

ATC CodeR07AX02 Other respiratory system products

Status

Authorised/WithdrawnAuthorised
Licence Issued16/11/2015
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing Status--Unknown--
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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