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


PROSTAP 6 DCS 30 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe



Takeda Products Ireland LtdPA2229/009/002

Main Information

Trade NamePROSTAP 6 DCS 30 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe
Active SubstancesLeuprorelin acetate
Dosage FormPowder and solvent for prolonged-release suspension for injection in pre-filled syringe
Licence HolderTakeda Products Ireland Ltd
Licence NumberPA2229/009/002

Group Information

ATC CodeL02AE Gonadotropin releasing hormone analogues
L02AE02 leuprorelin

Status

License statusAuthorised
Licence Issued08/04/2011
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

Documents

Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportPDF Version
« Back