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


Colobreathe



Teva B.V.EU/1/11/747/001

Main Information

Trade NameColobreathe
Active SubstancesColistimethate sodium (r inn)
Dosage FormInhalation powder, hard capsule
Licence HolderTeva B.V.
Licence NumberEU/1/11/747/001

Group Information

ATC CodeJ01XB Polymyxins
J01XB01 colistin

Status

License statusAuthorised
Licence Issued13/02/2012
Legal statusNot applicable
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusUnknown

Documents

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

Educational Materials - HCP

Educational Materials - Patient

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