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Gammanorm, 165 mg/mL, solution for injection



Octapharma (IP) SPRLPA2219/006/001

Main Information

Trade NameGammanorm, 165 mg/mL, solution for injection
Active SubstancesHuman normal immunoglobulin
Dosage FormSolution for injection
Licence HolderOctapharma (IP) SPRL
Licence NumberPA2219/006/001

Group Information

ATC CodeJ06BA Immunoglobulins, normal human
J06BA02 immunoglobulins, normal human, for intravascular adm.

Status

License statusAuthorised
Licence Issued01/06/2007
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceBatches of blood 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.
Marketing StatusNot marketed

Documents

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