In other countries
The same active substances on other registers, the same brand first.
- DimtruzicItaly · Capsula rigida gastroresistente · Sandoz S.P.A.Same brand
- Dimtruzic®Serbia · 240mg · gastrorezistentna kapsula, tvrda · PredstavniŠTvo Sandoz Pharmaceuticals D.D. BeogradSame brand
- Dimtruzic®Serbia · 120mg · gastrorezistentna kapsula, tvrda · PredstavniŠTvo Sandoz Pharmaceuticals D.D. BeogradSame brand
- Catira 120Argentina · 120 MG · cápsula gastrorresistentes · MS Synthon Bago S.A.Same form
- Apo-Dimethyl FumarateCanada · 120 MG · Capsule (Delayed-Release) · Apotex INCSame form
- Apo-Dimethyl FumarateCanada · 240 MG · Capsule (Delayed-Release) · Apotex INCSame form
- Auro-Dimethyl FumarateCanada · 240 MG · Capsule (Delayed-Release) · Auro Pharma INCSame form
- Fumarato de Dimetilo Accord 120 MG Capsulas Duras Gastrorresistentes EfgSpain · 120 mg · cápsula dura gastrorresistente · Accord Healthcare S.L.U.Same form
- Fumarato de Dimetilo Accord 240 MG Capsulas Duras Gastrorresistentes EfgSpain · 240 mg · cápsula dura gastrorresistente · Accord Healthcare S.L.U.Same form
- Fumarato de Dimetilo Aurovitas 240 MG Cápsulas Duras Gastrorresistentes EfgSpain · 240 mg · cápsula dura gastrorresistente · Aurovitas Spain, S.A.U.Same form
- BerbiraItaly · Capsula rigida gastroresistente · Adalvo LimitedSame form
- Dimetilfumarato AbdiItaly · Capsula rigida gastroresistente · Abdi Farma GmbHSame form
- Dimethylfumaraat Abdi 120 mg maagsapresistente capsules, hardNetherlands · Maagsapresistente capsule, hard · Abdi Farma GmbHSame form
- Dimethylfumaraat Abdi 240 mg maagsapresistente capsules, hardNetherlands · Maagsapresistente capsule, hard · Abdi Farma GmbHSame form
- Dimethylfumaraat Accord 120 mg harde maagsapresistente capsulesNetherlands · Maagsapresistente capsule, hard · Accord Healthcare S.L.U.Same form
- TecfideraNew Zealand · Cap 120 mgSame form
- TecfideraNew Zealand · Cap 240 mgSame form
- TECFIDERA 120 mgRomania · 120 mg · caps. gastrorez. · Biogen Netherlands B.V.Same form
- TECFIDERA 240 mgRomania · 240 mg · caps. gastrorez. · Biogen Netherlands B.V.Same form
- Difumarez®Serbia · 240mg · gastrorezistentna kapsula, tvrda · Galenika Ad BeogradSame form
- Defra 120MG Delayed Release CapsulesSaudi Arabia · Macleods Pharmaceuticals Ltd.Same form
- Defra 240MG Delayed Release CapsulesSaudi Arabia · Macleods Pharmaceuticals Ltd.Same form
- Sclera 120 MG CapsuleSaudi Arabia · Hikma Pharmaceuticals PLCSame form
- Tecfidera Gastro-Resistant Hard Capsules 120 MGSingapore · 120.0mg · capsule, enteric coated · Eisai (Singapore) Pte. LTD.Same form
- Tecfidera Gastro-Resistant Hard Capsules 240 MGSingapore · 240.0 mg · capsule, enteric coated · Eisai (Singapore) Pte. LTD.Same form
- Dimethyl FumarateUnited States · 120MG, 240MG · capsule, delayed release · Macleods Pharms LTDSame form
- TecfideraUnited States · 120MG, 240MG · capsule, delayed release · BiogenSame form
- DyfucertBrazil · DR. Reddys Farmacêutica do Brasil LtdaSame substance
- fumarato de dimetilaBrazil · Accord Farmacêutica LtdaSame substance
- fumarato de dimetilaBrazil · DR. Reddys Farmacêutica do Brasil LtdaSame substance
- Dimethyl fumarate AccordEuropean Union · Accord Healthcare LtdSame substance
- Dimethyl fumarate MylanEuropean Union · Mylan Pharmaceuticals LimitedSame substance
- Dimethyl fumarate NeuraxpharmEuropean Union · Neuraxpharm Pharmaceuticals S.L.Same substance
Packs
| Pack | Code | Status |
|---|---|---|
| 56 kapsula u blisteru, u kutiji | HR-H-631343747-01 | privremeni prekid opskrbe |
| 56 kapsula u blisteru s jediničnom dozom, u kutiji | HR-H-631343747-02 | nije stavljeno u promet |
| 168 kapsula u blisteru s jediničnom dozom, u kutiji | HR-H-631343747-03 | 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
- Dimethyl
- Dosage form
- Želučanootporna kapsula, tvrda
- Register
- Croatia (HALMED)
- Status
- Marketed
- Status in the register
- privremeni prekid opskrbe
- Authorised
- 30 Sept 2022
- Registration
- HR-H-631343747
- Marketing authorisation holder
- Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska
- Manufacturer
- Zakłady Farmaceutyczne Polpharma S.A., Nowa Dęba, Poljska Lek Pharmaceuticals d.d., Ljubljana, Slovenija
- ATC code
- L04AX07
- Procedure
- National, MRP or DCP
- Supply
- na recept; u ljekarni