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PECFENT

400 Microgram Nasal Spray Solution

Archimedes Development LimitedEU/1/10/644/003-004

Main Information

Trade NamePECFENT
Active SubstancesFENTANYL, AS CITRATE SALT
Strength400 Microgram
Dosage FormNasal Spray Solution
Licence HolderArchimedes Development Limited
Licence NumberEU/1/10/644/003-004

Group Information

ATC CodeN02AB03 Phenylpiperidine derivatives

Status

Authorised/WithdrawnAuthorised
Licence Issued31/08/2010
Supply StatusSupply through pharmacies only
Dispensing StatusProduct subject to prescription which may not be renewed (A)
Marketing StatusNot Marketed
Promotion StatusPromotion to Healthcare Professionals only
Conditions of LicenceMedicinal product subject to special and 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 1988 (S.I. No. 328 of 1988), as amended.

Documents

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