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


Spectrila

10.000 international unit(s) Powder and solvent for solution for injection/infusion

Medac Gesellschaft fur Klinische Spezialpraparate mbH EU/1/15/1072/001-002

Main Information

Trade NameSpectrila
Active SubstancesRecombinant l-asparaginase
Strength10.000 international unit(s)
Dosage FormPowder and solvent for solution for injection/infusion
Licence HolderMedac Gesellschaft fur Klinische Spezialpraparate mbH
Licence NumberEU/1/15/1072/001-002

Group Information

ATC CodeL01XX Other antineoplastic agents
L01XX02 asparaginase

Status

Authorised/WithdrawnAuthorised
Licence Issued14/01/2016
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing Status

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back