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Salofalk 1.5g prolonged-release granules



Dr. Falk Pharma GmbHPA0573/003/007

Main Information

Trade NameSalofalk 1.5g prolonged-release granules
Active SubstancesMesalazine
Dosage FormProlonged-release granules
Licence HolderDr. Falk Pharma GmbH
Licence NumberPA0573/003/007

Group Information

ATC CodeA07EC Aminosalicylic acid and similar agents
A07EC02 mesalazine

Status

License statusAuthorised
Licence Issued23/08/2013
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceFor products containing human albumin Batches of human albumin in medicinal products marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC as amended. For vaccines Batches of vaccine marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.1 of Directive 2001/83/EC as amended. For products derived from plasma Batches of plasma derived medicinal products marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.2 of Directive 2001/83/EC. For immunological medicinal products Batches of medicinal product marketed in Ireland shall be subject to control authority batch release in accordance with Article 114.1 of Directive 2001/83/EC as amended.
Marketing StatusMarketed

Documents

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