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Medicines
Spain
Fentanyl

AEMPS 2019

Fentanyl

Fentanilo Aristo 100 Microgramos Comprimidos Bucales Efg

0.16 mg comprimido bucalSpainMarketedAuthorised 2 Dec 2019

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

FentoraCanada · 400 MCG · Tablet (Effervescent) · Phoenix Labs Unlimited CompanySame form
FentoraCanada · 200 MCG · Tablet (Effervescent) · Phoenix Labs Unlimited CompanySame form
FentoraCanada · 100 MCG · Tablet (Effervescent) · Phoenix Labs Unlimited CompanySame form
AbstralItaly · Compressa sublinguale · Grunenthal Italia S.R.L.Same form
DogeticItaly · Compressa sublinguale · Sandoz S.P.A.Same form
EffentoraItaly · Compressa orosolubile · BB Farma S.R.L.Same form
Abstral 100 microgram, tabletten voor sublinguaal gebruikNetherlands · Tablet voor sublinguaal gebruik · Grünenthal B.V.Same form

More with the same substance on this register

Abattra 100 Microgramos/Hora Parches Transdermicos EfgFentanyl · 20,4 mg · parche transdérmicoSpain
Abattra 12 Microgramos/Hora Parches Transdermicos EfgFentanyl · 2,55 mg · parche transdérmico

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

🇳🇱Abstral 200 microgram, tabletten voor sublinguaal gebruikNetherlands · Tablet voor sublinguaal gebruik · Grünenthal B.V.Same form

🇳🇱Abstral 300 microgram, tabletten voor sublinguaal gebruikNetherlands · Tablet voor sublinguaal gebruik · Grünenthal B.V.Same form

🇸🇦Abstral 100MCG Sublingual TabletSaudi Arabia · Recipharm ParetsSame form

🇸🇦Abstral 200MCG Sublingual TabletSaudi Arabia · Recipharm ParetsSame form

🇸🇬ABSTRAL SUBLINGUAL TABLET 100 mcgSingapore · 100 µg · tablet · A. Menarini Singapore Pte. LTD.Same form

🇸🇬ABSTRAL SUBLINGUAL TABLET 200 mcgSingapore · 200 µg · tablet · A. Menarini Singapore Pte. LTD.Same form

🇸🇬ABSTRAL SUBLINGUAL TABLET 300 mcgSingapore · 300 µg · tablet · A. Menarini Singapore Pte. LTD.Same form

🇺🇸ActiqUnited States · 0.2MG BASE, 0.4MG BASE, 0.6MG BASE … · troche/lozenge · CephalonSame form

🇺🇸AbstralUnited States · 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** … · tablet · Sentynl Theraps INCSame form

🇺🇸FentanylUnited States · 0.1MG BASE, 0.2MG BASE, 0.3MG BASE … · troche/lozenge · CephalonSame form

🇧🇷AnesfentBrazil · Laboratório Teuto Brasileiro S/ASame substance

🇧🇷citrato de fentanilaBrazil · Newcom Farmaceutica Ltda.Same substance

🇧🇷citrato de fentanilaBrazil · Laboratório Teuto Brasileiro S/ASame substance

🇪🇺EffentoraEuropean Union · Phoenix Labs Unlimited CompanySame substance

🇪🇺InstanylEuropean Union · Istituto Gentili S.r.l.Same substance

🇪🇺PecFentEuropean Union · Gruenenthal GmbHSame substance

🇭🇷Durogesic 100 mikrograma/sat transdermalni flasterCroatia · transdermalni flaster · Johnson & Johnson S.E. d.o.o., Oreškovićeva 6h, Zagreb, HrvatskaSame substance

🇭🇷Durogesic 25 mikrograma/sat transdermalni flasterCroatia · transdermalni flaster · Johnson & Johnson S.E. d.o.o., Oreškovićeva 6h, Zagreb, HrvatskaSame substance

🇭🇷Durogesic 50 mikrograma/sat transdermalni flasterCroatia · transdermalni flaster · Johnson & Johnson S.E. d.o.o., Oreškovićeva 6h, Zagreb, HrvatskaSame substance

🇳🇿AnyNew Zealand · Inj 20 mcg per ml, 100 ml bagSame substance

🇳🇿BiomedNew Zealand · Inj 10 mcg per ml, 100 ml bagSame substance

🇳🇿BiomedNew Zealand · Inj 20 mcg per ml, 50 ml syringeSame substance

🇷🇴ALGOGESIC 100 micrograme/oraRomania · 100micrograme/ora · plasture transdermic · Zentiva K.S.Same substance

🇷🇴ALGOGESIC 25 micrograme/oraRomania · 25micrograme/ora · plasture transdermic · Zentiva K.S.Same substance

🇷🇴ALGOGESIC 50 micrograme/oraRomania · 50micrograme/ora · plasture transdermic · Zentiva K.S.Same substance

🇷🇸Durogesic®Serbia · 75mcg/h · transdermalni flaster · PredstavniŠTvo Janssen-Cilag KFT BeogradSame substance

🇷🇸Durogesic®Serbia · 25mcg/h · transdermalni flaster · PredstavniŠTvo Janssen-Cilag KFT BeogradSame substance

🇷🇸Durogesic®Serbia · 100mcg/h · transdermalni flaster · PredstavniŠTvo Janssen-Cilag KFT BeogradSame substance

🇸🇦Durogesic 12MCG-H Trasdermal PatchesSaudi Arabia · Janssen Pharmaceutica N.V.Same substance

Packs

Pack	Code	Status
FENTANILO ARISTO 100 MICROGRAMOS COMPRIMIDOS BUCALES EFG, 4 comprimidos	727486
FENTANILO ARISTO 100 MICROGRAMOS COMPRIMIDOS BUCALES EFG, 28 comprimidos	727488

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Fentanyl
Strength: 0.16 mg
Dosage form: comprimido bucal
Route: Vía bucal (buccal use)
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 2 Dec 2019
Registration: 84694
Marketing authorisation holder: Aristo Pharma Gmbh
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica. Estupefacientes

🇪🇸Spain

AEMPSAbattra 25 Microgramos/Hora Parches Transdermicos EfgFentanyl · 5,1 mg · parche transdérmico🇪🇸Spain

AEMPSAbattra 50 Microgramos/Hora Parches Transdermicos EfgFentanyl · 10,2 mg · parche transdérmico🇪🇸Spain

AEMPSAbattra 75 Microgramos/Hora Parches Transdermicos EfgFentanyl · 15,3 mg · parche transdérmico🇪🇸Spain

AEMPSAbfentiq 200 Microgramos Comprimidos Para Chupar EfgFentanyl · 0,3142 mg · comprimido para chupar🇪🇸Spain

AEMPSAbfentiq 400 Microgramos Comprimidos Para Chupar EfgFentanyl · 0,6284 mg · comprimido para chupar🇪🇸Spain

AEMPSAbfentiq 600 Microgramos Comprimidos Para Chupar EfgFentanyl · 0,9425 mg · comprimido para chupar🇪🇸Spain

AEMPSAbfentiq 800 Microgramos Comprimidos Para Chupar EfgFentanyl · 1,2567 mg · comprimido para chupar🇪🇸Spain

AEMPSABSTRAL 100 microgramos COMPRIMIDOS SUBLINGUALESFentanyl · 0,1571 mg · comprimido sublingual🇪🇸Spain

AEMPSABSTRAL 200 microgramos COMPRIMIDOS SUBLINGUALESFentanyl · 0,3142 mg · comprimido sublingual🇪🇸Spain

AEMPSABSTRAL 300 microgramos COMPRIMIDOS SUBLINGUALESFentanyl · 0,47113 mg · comprimido sublingual🇪🇸Spain