In other countries
The same active substances on other registers, the same brand first.
- Siklos 1.000 MG Comprimidos Recubiertos con PeliculaSpain · 1000 mg · comprimido recubierto con película · TheraviaSame brand
- Siklos 100 MG Comprimidos Recubiertos con PeliculaSpain · 100 mg · comprimido recubierto con película · TheraviaSame brand
- SiklosEuropean Union · TheraviaSame brand
- SiklosCroatiaSame brand
- Siklos filmomhulde tabletten, 100 mgNetherlands · Filmomhulde tablet · TheraviaSame brand
- Siklos, filmomhulde tabletten 1000 mgNetherlands · Filmomhulde tablet · TheraviaSame brand
- SiklosUnited States · 100MG, 1GM · tablet · TheraviaSame brand
- HydroxyureaUnited States · 1GM · tablet · BarrSame form
- Apo-HydroxyureaCanada · 500 MG · Capsule · Apotex INCSame substance
- HydreaCanada · 500 MG · Capsule · Cheplapharm Arzneimittel GMBHSame substance
- Mylan-HydroxyureaCanada · 500 MG · Capsule · Mylan Pharmaceuticals UlcSame substance
- HYDREA 500 mg CAPSULAS DURASSpain · 500 mg · cápsula dura · Cheplapharm Arzneimittel GmbhSame substance
- XromiEuropean Union · Lipomed GmbHSame substance
- Litalir 500 mg tvrde kapsuleCroatia · kapsula, tvrda · Cheplapharm Arzneimittel GmbH, Ziegelhof 24, Greifswald, NjemačkaSame substance
- Xybaid 500 mg tvrde kapsuleCroatia · kapsula, tvrda · Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, HrvatskaSame substance
- Hydroxycarbamide Devatis 500mg, harde capsulesNetherlands · Capsule, hard · Devatis GmbHSame substance
- DevatisNew Zealand · Cap 500 mgSame substance
- HYDREA 500 mgRomania · 500mg · caps. · Bristol Myers Squibb KFTSame substance
- Litalir®Serbia · 500mg · kapsula, tvrda · Clinres Farmacija D.O.O. BeogradSame substance
- Litalir®Serbia · 500mg · kapsula, tvrda · Clinres Farmacija D.O.O. BeogradSame substance
- CUREAML 500 mg CapsulesSaudi Arabia · The Arab Pharmaceutical Manufacturing PSC SultSame substance
- XromiSaudi Arabia · Nova Laboratories LtdSame substance
- HYDRINE CAPSULES 500 mgSingapore · 500 mg · capsule · Shoei Universal Corporation Pte LTDSame substance
- Hydrea Capsules 500MGTaiwan · 膠囊劑 · 台灣大昌華嘉股份有限公司Same substance
- HydreaUnited States · 500MG · capsule · Waylis TherapSame substance
Packs
| Pack | Code | Status |
|---|---|---|
| 1000 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE RIVESTITE CON FILM | 045338011 | Autorizzata |
| 100 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 60 COMPRESSE RIVESTITE CON FILM | 045338023 | Autorizzata |
| 100 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 90 COMPRESSE RIVESTITE CON FILM | 045338035 | Autorizzata |
| 100 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 120 COMPRESSE RIVESTITE CON FILM | 045338047 | Autorizzata |
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Agenzia Italiana del Farmaco (AIFA); https://drive.aifa.gov.it/farmaci/confezioni_fornitura.csv; HTTP Last-Modified Mon, 12 Oct 2026 23:02:44 GMT; acquired 2026-10-13T17:21:16.224007+00:00; native fields retained, source identifier and role projections are adaptations.
Licence: CC BY 4.0; AIFA published open-data catalog · Added 13 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
- Hydroxycarbamide
- Dosage form
- Compressa rivestita con film
- Register
- Italy (AIFA)
- Status
- Authorised
- Status in the register
- Autorizzata
- Registration
- AIC 045338
- Marketing authorisation holder
- Theravia
- ATC code
- L01XX05
- Procedure
- Procedura Centralizzata
- Supply
- Medicinali soggetti a prescrizione medica limitativa, da rinnovare volta per volta, vendibili al pubblico su prescrizione di centri ospedalieri o di specialisti



