Skip to content

Sign in Start free

Create your free account

Loading your page…

We care for the people who care.

No ads. No selling of your data. No third-party trackers.

Apps

Prognia
Ward
Suture
Osler

Library

Guidelines
Medicines
Articles
Calculators
Explore decks
Institutions
Pharmaceutical companies
Blog

Prognia

About
Pricing
Contact

Support us

Founders Wall

© 2026 Prognia · Amsterdam, the NetherlandsPrivacy TermsExchangeRate-API

Loading…

Medicines
Spain
Tranexamic acid

AEMPS 2022

Tranexamic acid

Medsamic 100 MG/ML Solucion Inyectable Efg

100 mg/ml solución inyectableSpainMarketedAuthorised 21 Mar 2022

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.

Medsamic 500 mg filmom obložene tableteCroatia · Filmom obložena tableta · Medochemie Ltd., Constatinoupoleos Str. 1-10, Limassol, CiparSame brand
Medsamic Solution for Injection 100MG/MLSingapore · 100mg/ml · injection, solution · Medochemie Singapore Pte. LTD.Same brand
CYKLOKAPRON INJECTION 100 mg/mlSingapore · 100 mg/ml · injection · Pfizer Private LimitedSame strength and form
Haemostop Injection 100MG/MLSingapore · 100mg/ml · injection, solution · Goldplus Universal Pte LTDSame strength and form
CyklokapronUnited States · 100MG/ML · injectable · PfizerSame strength and form
Tranexamic AcidUnited States · 100MG/ML · injectable · Mylan InstitutionalSame strength and form

More with the same substance on this register

Acido Tranexamico Viatris 100 MG/ML Solucion Inyectable EfgTranexamic acid · 500 mg · solución inyectableSpain
ACIDO TRANEXAMICO ZENTIVA 500 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFGTranexamic acid · 500 mg · comprimido recubierto con película

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.

🇭🇷

Trenolk 100 mg/ml otopina za injekcijuCroatia · otopina za injekciju · Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, Hrvatska

Same form

🇮🇹Acido Tranexamico AurobindoItaly · Soluzione iniettabile · Eugia Pharma (Malta) LimitedSame form

🇮🇹Acido Tranexamico Bioindustria L.I.M.Italy · Soluzione iniettabile · Bioindustria Laboratorio Italiano Medicinali S.P.A.Same form

🇮🇹UgurolItaly · Soluzione iniettabile · Viatris Italia S.R.L.Same form

🇳🇱Tranexaminezuur Accord 100 mg/ml oplossing voor injectieNetherlands · Oplossing voor injectie · Accord Healthcare B.V.Same form

🇳🇱Tranexaminezuur Baxter 100 mg/ml, oplossing voor injectie/infusieNetherlands · Oplossing voor injectie of infusie · Baxter B.V.Same form

🇳🇱Tranexaminezuur Kabi 10 mg/ml oplossing voor infusieNetherlands · Oplossing voor infusie · Fresenius Kabi Nederland B.V.Same form

🇳🇿Tranexamic-AFTNew Zealand · Inj 100 mg per ml, 5 ml ampouleSame form

🇳🇿Tranexamic-AFTNew Zealand · Inj 100 mg per ml, 10 ml ampouleSame form

🇷🇸Tranexamic Medochemie®Serbia · 500mg/5mL · rastvor za injekciju · Farmalogist D.O.O. BeogradSame form

🇸🇦Azeptil 100 mg/ml InjectionSaudi Arabia · Medochemie LTD Pharmaceutical IndustrySame form

🇸🇦Cyklokapron Inj 100MG-ML 5MLSaudi Arabia · OctapharmaSame form

🇸🇦Cyklokapron Inj 100MG-ML InjectionSaudi Arabia · Pfizer Manufacturing Belgium N.V.Same form

🇧🇷Ácido TranexâmicoBrazil · Hipolabor Farmaceutica LtdaSame substance

🇧🇷ácido tranexâmicoBrazil · Ems S/ASame substance

🇧🇷ácido tranexâmicoBrazil · Legrand Pharma Indústria Farmacêutica LtdaSame substance

🇨🇦Cyklokapron 100 MG/MLCanada · 100 MG / ML · Solution · Pfizer Canada UlcSame substance

🇨🇦Tranexamic Acid InjectionCanada · 100 MG / ML · Solution · Omega Laboratories LimitedSame substance

🇨🇦Tranexamic Acid InjectionCanada · 100 MG / ML · Solution · Auro Pharma INCSame substance

🇭🇷Trenolk 500 mg filmom obložene tableteCroatia · Filmom obložena tableta · Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, HrvatskaSame substance

🇳🇿Mercury PharmaNew Zealand · Tab 500 mgSame substance

🇷🇸Trenolk®Serbia · 500mg · film tableta · Makpharm D.O.O.Same substance

🇹🇼Tranexamic Capsules 250MG "Jinup"Taiwan · 膠囊劑 · 瑞人企業股份有限公司Same substance

🇺🇸LystedaUnited States · 650MG · tablet · Amring PharmsSame substance

Packs

Pack	Code	Status
MEDSAMIC 100 MG/ML SOLUCION INYECTABLE EFG, 10 ampollas de 5 ml	733089
MEDSAMIC 100 MG/ML SOLUCION INYECTABLE EFG, 10 ampollas de 10 ml	733090

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: Tranexamic acid
Strength: 100 mg/ml
Dosage form: solución inyectable
Route: vía intravenosa
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 21 Mar 2022
Registration: 86353
Marketing authorisation holder: Medochemie Limited
Procedure: National, MRP or DCP
Supply: Medicamento Sujeto A Prescripción Médica

🇪🇸Spain

AEMPSAmchafibrin 500 MG Comprimidos Recubiertos con PeliculaTranexamic acid · 500 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAMCHAFIBRIN 500 mg SOLUCION INYECTABLETranexamic acid · 500 mg · solución inyectable🇪🇸Spain

AEMPSAcido Tranexamico Baxter 100 MG/ML Solucion Inyectable EfgTranexamic acid · 100 mg/ml · solucion inyectable y para perfusion🇪🇸Spain

AEMPSNexag 1.000 MG Granulado Recubierto en SobresTranexamic acid · 1.000 mg · granulado recubierto en sobre🇪🇸Spain

AEMPSTantiramix 500 MG Comprimidos Recubiertos con PeliculaTranexamic acid · 500 mg · comprimido recubierto con película🇪🇸Spain

AEMPSAcido Tranexamico Aurovitas 100 MG/ML Solucion Inyectable EfgTranexamic acid · 100 mg · solución inyectable🇪🇸SpainWithdrawn

AEMPSAMCHAFIBRIN 500 mg COMPRIMIDOSTranexamic acid · 500 mg · comprimido🇪🇸SpainWithdrawn