In other countries
The same active substances on other registers, the same brand first.
- Auro-BetahistineCanada · 24 MG · Tablet · Auro Pharma INCSame form
- Auro-BetahistineCanada · 8 MG · Tablet · Auro Pharma INCSame form
- Auro-BetahistineCanada · 16 MG · Tablet · Auro Pharma INCSame form
- FIDIUM 8 mg COMPRIMIDOSSpain · 8 mg · comprimido · Meda Pharma S.L.Same form
- AverbetItaly · Compressa · Tecnigen S.R.L.Same form
- Betaistina AccordItaly · Compressa · Accord Healthcare, S.L.U.Same form
- Betaistina AurobindoItaly · Compressa · Aurobindo Pharma (Italia) S.R.L.Same form
- Betahistine 2 HCl Accord 16 mg tablettenNetherlands · Tablet · Accord Healthcare B.V.Same form
- Betahistine 2 HCl Accord 8 mg tablettenNetherlands · Tablet · Accord Healthcare B.V.Same form
- Betahistine 2HCl 16 mg, tablettenNetherlands · Tablet · GenRx B.V.Same form
- SercNew Zealand · Tab 16 mgSame form
- BETASERC 24 mgRomania · 24 mg · compr. orodispersabile · Mylan Ire Healthcare LimitedSame form
- BETASERC 24mgRomania · 24mg · compr. orodispersabile · Mylan Healthcare GMBHSame form
- Betahistin-dihidrohlorid AccordSerbia · 24mg · tableta · Evropa Lek Pharma D.O.O. BeogradSame form
- Betahistin-dihidrohlorid AccordSerbia · 8mg · tableta · Evropa Lek Pharma D.O.O. BeogradSame form
- Betahistin-dihidrohlorid AccordSerbia · 8mg · tableta · Evropa Lek Pharma D.O.O. BeogradSame form
- Bertigo 16 MG TabletSaudi Arabia · Jazeera Pharmaceutical Industries (JPI)Same form
- Bertigo 24 MG TabletSaudi Arabia · Jazeera Pharmaceutical Industries (JPI)Same form
- Bertigo 8 MG TabletSaudi Arabia · Jazeera Pharmaceutical Industries (JPI)Same form
- BETASERC 24 TABLET 24 mgSingapore · 24 mg · tablet · Abbott Laboratories (Singapore ) Private LimitedSame form
- BETASERC TABLETS 16 mgSingapore · 16 mg · tablet · Abbott Laboratories (Singapore ) Private LimitedSame form
- GP-Betahistine Tablets 24MGSingapore · 24mg · tablet · Goldplus Universal Pte LTDSame form
- BelnoaBrazil · Prati Donaduzzi & Cia LtdaSame substance
- BetadineBrazil · Aché Laboratórios Farmacêuticos S.ASame substance
- Betadine XRBrazil · Aché Laboratórios Farmacêuticos S.ASame substance
- BETAHISTIN MCC 24 mgRomania · 24mg · compr. · Magistra C&C SRLSame substance
- Meginalisk TabletsTaiwan · 錠劑 · 全益貿易股份有限公司Same substance
- Mellite Tablets "Mitsui"Taiwan · 錠劑 · 中信貿易股份有限公司Same substance
Packs
| Pack | Code | Status |
|---|---|---|
| 32 tablete u blisteru, u kutiji | HR-H-398555791-01 | nije stavljeno u promet |
| 60 tableta u blisteru, u kutiji | HR-H-398555791-02 | nije stavljeno u promet |
| 100 tableta u blisteru, u kutiji | HR-H-398555791-03 | 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
- Betahistine
- Dosage form
- Tableta
- Register
- Croatia (HALMED)
- Status
- Not marketed
- Status in the register
- nije stavljeno u promet
- Authorised
- 3 Aug 2026
- Registration
- HR-H-398555791
- Marketing authorisation holder
- PharmaS d.o.o., Radnička cesta 47, Zagreb, Hrvatska
- Manufacturer
- Terapia S.A., Cluj-Napoca, Rumunjska Emona Biopharma razvoj proizvodnja in prodaja d.o.o., Ljubljana, Slovenija
- ATC code
- N07CA01
- Group
- Nervous system
- Procedure
- National, MRP or DCP
- Supply
- na recept; u ljekarni