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Medicines
Croatia
Flumazenil

HALMED 2018

Flumazenil

Flumazenil B. Braun 0,1 mg/ml otopina za injekciju/infuziju

otopina za injekciju/infuzijuCroatiaMarketedAuthorised 22 Jan 2018

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On this page

In other countries
Packs
Sources and licences

In other countries

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

ANEXATE 0,5 mg/5 ml SOLUCION INYECTABLESpain · 0,1 mg · solución inyectable · Cheplapharm Arzneimittel GmbhSame form
ANEXATE 1 mg/10 ml SOLUCION INYECTABLESpain · 1 mg · solución inyectable · Cheplapharm Arzneimittel GmbhSame form
Flumazenil Altan 0,1 MG/ML Solucion Inyectable EfgSpain · 0,10 mg · solución inyectable · Altan Pharmaceuticals SaSame form
AnexateItaly · Soluzione iniettabile · Cheplapharm Arzneimittel GMBHSame form
Flumazenil B. BraunItaly · Soluzione iniettabile · B. Braun Melsungen AGSame form
Flumazenil HamelnItaly · Soluzione iniettabile · Hameln Pharma GMBHSame form

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.

🇳🇱

Anexate, 0,5 mg/5 ml en 1,0 mg/ 10 ml oplossing voor injectieNetherlands · Oplossing voor injectie · CHEPLAPHARM Arzneimittel GmbH

Same form

🇳🇱Flumazenil B. Braun 0,1 mg/ml, oplossing voor injectie 0,5 mg/5 ml en 1,0 mg/10 mlNetherlands · Oplossing voor injectie · B. Braun Melsungen AG (Melsungen)Same form

🇳🇱Flumazenil hameln 0,1 mg/ml, oplossing voor injectie/infusieNetherlands · Oplossing voor injectie, Concentraat voor oplossing voor infusie · hameln pharma gmbhSame form

🇳🇿Flumazenil-BaxterNew Zealand · Inj 0.1 mg per ml, 5 ml ampouleSame form

🇷🇴ANEXATE 0,1 mg/mlRomania · 0,1mg/ml · sol. inj. · Cheplapharm Arzneimittel GMBHSame form

🇷🇴FLUMAZENIL PANPHARMA 0.1 mg/mlRomania · 0.1 mg/ml · sol. inj./perf. · PanpharmaSame form

🇷🇸Anexate®Serbia · 1mg/10mL · rastvor za injekciju/infuziju · Clinres Farmacija D.O.O. BeogradSame form

🇷🇸Anexate®Serbia · 0.5mg/5mL · rastvor za injekciju/infuziju · Clinres Farmacija D.O.O. BeogradSame form

🇸🇬ANEXATE INJECTION 0.5 mg/5 mlSingapore · 0.5 mg/5 ml · injection · DKSH Singapore Pte. LTD.Same form

🇸🇬Flumazenil-Baxter Solution for Injection 0.5 MG/5 MLSingapore · 0.1 mg/mL · injection, solution · Baxter Healthcare (Asia) Pte LTDSame form

🇸🇬Flumazenil-Baxter Solution for Injection 1 MG/10 MLSingapore · 0.1 mg/mL · injection, solution · Baxter Healthcare (Asia) Pte LTDSame form

🇺🇸FlumazenilUnited States · 0.5MG/5ML, 1MG/10ML · injectable · SandozSame form

🇺🇸RomaziconUnited States · 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable · Hoffmann LA RocheSame form

🇧🇷flumazenilBrazil · União Química Farmacêutica Nacional S/ASame substance

🇧🇷flumazenilBrazil · Newcom Farmaceutica Ltda.Same substance

🇧🇷flumazenilBrazil · Hipolabor Farmaceutica LtdaSame substance

🇨🇦Flumazenil InjectionCanada · 0.1 MG / ML · Solution · Sandoz Canada IncorporatedSame substance

🇨🇦Flumazenil Injection, USPCanada · 0.1 MG / ML · Solution · Fresenius Kabi Canada LTDSame substance

🇨🇦Jamp-FlumazenilCanada · 0.1 MG / ML · Solution · Jamp Pharma CorporationSame substance

🇸🇦Anexate 0.5MG Amp 5MLSaudi Arabia · CenexiSame substance

🇸🇦ExitineSaudi Arabia · MS PharmaSame substance

🇸🇦Flumazenil PSISaudi Arabia · Pharmaceutical Solutions IndustrySame substance

🇹🇼Anexate AmpouleTaiwan · 注射劑 · 裕利股份有限公司Same substance

Packs

Pack	Code	Status
5 ampula s 5 ml otopine, u kutiji	HR-H-035174914-01	stavljeno u promet
10 ampula s 5 ml otopine, u kutiji	HR-H-035174914-02	nije stavljeno u promet

Sources and licences

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

HALMED — Agencija za lijekove i medicinske proizvode RH

HALMED, Baza lijekova, source export 08.10.2026., acquired 2026-10-08; factual structured adaptation; Otvorena dozvola RH, NN 67/2017.

Licence: Otvorena dozvola RH NN 67/2017 · Added 8 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: Flumazenil
Dosage form: otopina za injekciju/infuziju
Register: Croatia (HALMED)
Status: Marketed
Status in the register: stavljeno u promet; nema nestašice
Authorised: 22 Jan 2018
Registration: HR-H-035174914
Marketing authorisation holder: B. Braun Adria d.o.o., Hondlova 2/9, Zagreb
Manufacturer: B. Braun Melsungen AG, Melsungen, Njemačka
ATC code: V03AB25
Group: Various
Procedure: National, MRP or DCP
Supply: na recept; u ljekarni