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Medicines
Spain
Lidocaine

AEMPS 2016

Lidocaine, Prilocaine

Fortacin 150 MG/ML + 50 MG/ML Solucion Para Pulverizacion Cutanea

150 ml + 50 ml solución para pulverización cutáneaSpainAuthorisedAuthorised 27 Oct 2016

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.

FortacinEuropean Union · Recordati Ireland Ltd.Same brand
FortacinCroatiaSame brand
FortacinItaly · spray · Recordati Ireland LTDSame brand
Fortacin 150 mg/ml + 50 mg/ml huidspray, oplossingNetherlands · Huidspray, oplossing · Recordati Ireland Ltd. (Co. Cork)Same brand
FORTACIN 150 mg/ml+50 mg/mlRomania · 150mg/ml+50mg/ml · spray cut. sol. · Recordati Ireland LTD.Same brand
FORTACIN CUTANEOUS SPRAY SOLUTION 7.5MG/dose + 2.5MG/doseSingapore · 7.5 mg/dose + 2.5mg/dose · spray, metered · Orient Europharma Pte LTDSame brand
Emla CreamCanada · 2.5 % + 2.5 % · Cream · Aspen Pharmacare Canada INC.

More with the same substance on this register

Anamap 25 MG/G + 25 MG/G CremaLidocaine + Prilocaine · 25 mg + 25 mg · cremaSpain
Anestderma 25 MG/G + 25 MG/G CremaLidocaine + Prilocaine · 25 mg + 25 mg · cremaSpain

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.

Same form

🇨🇦OraqixCanada · 2.5 % + 2.5 % · Gel · Dentsply Canada LimitedSame form

🇨🇦Odan Lidocaine-Prilocaine CreamCanada · 2.5 % + 2.5 % · Cream · Odan LaboratoriesltdSame form

🇮🇹EmlaItaly · Crema · Farma 1000 S.R.L.Same form

🇮🇹EmlaItaly · Crema · GMM Farma S.R.L.Same form

🇳🇱Emla, hydrofiele creme 5%Netherlands · Crème · Eureco-Pharma B.V.Same form

🇳🇱emla, hydrofiele creme 5%Netherlands · Crème · Aspen Pharma Trading LimitedSame form

🇸🇦ENNLA 5% CreamSaudi Arabia · Deef Pharmaceutical IndustriesSame form

🇸🇦ENNLA 5% CreamSaudi Arabia · Deef Pharmaceutical IndustriesSame form

🇸🇦ENNLA 5% CreamSaudi Arabia · Deef Pharmaceutical IndustriesSame form

🇸🇬Emla Cream 5%Singapore · 25 mg/g + 25 mg/g · cream · DCH Auriga SingaporeSame form

🇸🇬Racser Cream 5%Singapore · 2.5%w/w + 2.5%w/w · cream · Euro Asia Medico Pte. LTD.Same form

🇺🇸Lidocaine and PrilocaineUnited States · 2.5%; 2.5% · cream · Fougera PharmsSame form

🇺🇸OraqixUnited States · 2.5%; 2.5% · gel · Dentsply PharmSame form

🇺🇸EmlaUnited States · 2.5%; 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · cream · Teva Branded PharmSame form

🇧🇷EmlaBrazil · Aspen Pharma Indústria Farmacêutica LtdaSame substance

🇧🇷MedicaínaBrazil · Cristália Produtos Químicos Farmacêuticos Ltda.Same substance

🇧🇷EmlaBrazil · Astrazeneca do Brasil LtdaSame substance

🇪🇺SenstendEuropean Union · Plethora Pharma Solutions LimitedSame substance

🇳🇿EmlaNew Zealand · Crm 2.5% with prilocaine 2.5%, 5 gSame substance

🇳🇿EmlaNew Zealand · Crm 2.5% with prilocaine 2.5%Same substance

🇳🇿EmlaNew Zealand · Crm 2.5% with prilocaine 2.5% (5 g tubes)Same substance

🇷🇸Rebelia®Serbia · 25mg/g+25mg/g · krem · Hemofarm Ad VRŠAcSame substance

Packs

Pack	Code	Status
FORTACIN 150 MG/ML + 50 MG/ML SOLUCION PARA PULVERIZACION CUTANEA, 1 aerosol de 5,0 ml	713325

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 substances: Lidocaine, Prilocaine
Strength: 150 ml + 50 ml
Dosage form: solución para pulverización cutánea
Route: uso cutáneo
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 27 Oct 2016
Registration: 113881002
Marketing authorisation holder: Recordati Ireland Limited
Procedure: EU centralised
Supply: Sin Receta

AEMPSAnestopic 25 MG/G + 25 MG/G CremaLidocaine + Prilocaine · 2,5 g + 2,5 g · crema🇪🇸Spain

AEMPSEMLA 25 mg/g + 25 mg/g CREMALidocaine + Prilocaine · 25 mg + 25 mg · crema🇪🇸Spain

AEMPSOraqix Gel PeriodontalLidocaine + Prilocaine · 25 mg + 25 mg · gel periodontal🇪🇸Spain

AEMPSAnesteal 25MG/G + 25MG/G CremaLidocaine + Prilocaine · 2,5 g + 2,5 g · crema🇪🇸SpainWithdrawn

AEMPSLidocaina/Prilocaina Ratiopharm 25MG/G + 25MG/G CremaLidocaine + Prilocaine · 2,5 % + 2,5 % · crema🇪🇸SpainWithdrawn