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Roaccutane 10 mg soft capsules

Roche Products (Ireland) Ltd PA2307/007/001

Main Information

Trade NameRoaccutane 10 mg soft capsules
Active SubstancesIsotretinoin
Dosage FormCapsule, soft
Licence HolderRoche Products (Ireland) Ltd
Licence NumberPA2307/007/001

Group Information

ATC CodeD10BA Retinoids for treatment of acne
D10BA01 isotretinoin


License statusAuthorised
Licence Issued20/11/2006
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusMarketed


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available

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