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


Instanyl



Istituto Gentili S.r.l.EU/1/09/531/4-6

Main Information

Trade NameInstanyl
Active SubstancesFENTANYL CITRATE
Dosage FormNasal spray, solution
Licence HolderIstituto Gentili S.r.l.
Licence NumberEU/1/09/531/4-6

Group Information

ATC CodeN02AB Phenylpiperidine derivatives
N02AB03 fentanyl

Status

License statusAuthorised
Licence Issued20/07/2009
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). This product contains a substance listed in schedule 2 to the Misuse of Drugs Regulations 2017.
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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