The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


Octanate 500 IU powder and solvent for solution for injection

500 international unit(s) Powder and solvent for solution for injection

Octapharma (IP) SPRLPA2219/004/002

Main Information

Trade NameOctanate 500 IU powder and solvent for solution for injection
Active SubstancesHuman coagulation factor viii
Strength500 international unit(s)
Dosage FormPowder and solvent for solution for injection
Licence HolderOctapharma (IP) SPRL
Licence NumberPA2219/004/002

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD02 coagulation factor VIII

Status

Authorised/WithdrawnAuthorised
Licence Issued28/11/2014
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 StatusNot marketed

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletNo document available
Public Assessment ReportNo document available
« Back