In other countries
The same active substances on other registers, the same brand first.
- BosulifCanada · 500 MG · Tablet · Pfizer Canada UlcSame form
- BosulifCanada · 100 MG · Tablet · Pfizer Canada UlcSame form
- Reddy-BosutinibCanada · 100 MG · Tablet · DR Reddy'S Laboratories LTDSame form
- Bosulif 100 MG Comprimidos Recubiertos con PeliculaSpain · 100 mg · comprimido recubierto con película · Pfizer Europe Ma EeigSame form
- Bosulif 400 MG Comprimidos Recubiertos con PeliculaSpain · 413,6 mg · comprimido recubierto con película · Pfizer Europe Ma EeigSame form
- Bosulif 500 MG Comprimidos Recubiertos con PeliculaSpain · 500 mg · comprimido recubierto con película · Pfizer Europe Ma EeigSame form
- BosulifItaly · Compressa rivestita con film · Pfizer Europe Ma EeigSame form
- Bosutinib DR. Reddy?SItaly · Compressa rivestita con film · DR. Reddy'S S.R.L.Same form
- Bosutinib EgItaly · Compressa rivestita con film · Eg S.P.A.Same form
- Bosulif 100 mg, Filmomhulde tabletNetherlands · Filmomhulde tablet · Pfizer Europe MA EEIGSame form
- Bosulif 400 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Pfizer Europe MA EEIGSame form
- Bosulif 500 mg, Filmomhulde tabletNetherlands · Filmomhulde tablet · Pfizer Europe MA EEIGSame form
- BosulifUnited States · 100MG BASE, 400MG BASE, 500MG BASE · tablet · PF Prism CVSame form
- Bosutinib MonohydrateUnited States · 100MG BASE, 500MG BASE · tablet · AlembicSame form
- BosutinibUnited States · 100MG BASE, 400MG, 500MG BASE · tablet · MSN Laboratories Private LTDSame form
- BosulifBrazil · Pfizer Brasil LtdaSame substance
- BosulifEuropean Union · Pfizer Europe MA EEIGSame substance
- BOSULIF 100 mgRomania · 100mg · compr. film. · Pfizer LimitedSame substance
- BOSULIF 100 mgRomania · 100 mg · compr. film. · Pfizer Europe Ma EeigSame substance
- BOSULIF 500 mgRomania · 500 mg · compr. film. · Pfizer Europe Ma EeigSame substance
- BosulifSaudi Arabia · Pfizer Manufacturing Deutschland GmbHSame substance
- VolopemSaudi Arabia · The Arab Pharmaceutical Manufacturing PSC (Sahab) Co LtdSame substance
- Bostini Film-coated Tablets 100 mgTaiwan · 膜衣錠 · 美時化學製藥股份有限公司Same substance
- Bostini Film-coated Tablets 400 mgTaiwan · 膜衣錠 · 美時化學製藥股份有限公司Same substance
- Bostini Film-coated Tablets 500 mgTaiwan · 膜衣錠 · 美時化學製藥股份有限公司Same substance
Packs
| Pack | Code | Status |
|---|---|---|
| 28 tableta u blisteru, u kutiji | HR-H-052134264-01 | nije stavljeno u promet |
| 30 tableta u blisteru, u kutiji | HR-H-052134264-02 | nije stavljeno u promet |
| 112 tableta u blisteru, u kutiji | HR-H-052134264-03 | nije stavljeno u promet |
| 28 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-052134264-04 | nije stavljeno u promet |
| 30 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-052134264-05 | nije stavljeno u promet |
| 112 tableta u blisteru s jediničnom dozom, u kutiji | HR-H-052134264-06 | 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
- Bosutinib
- Dosage form
- Filmom obložena tableta
- Register
- Croatia (HALMED)
- Status
- Not marketed
- Status in the register
- nije stavljeno u promet
- Authorised
- 20 Aug 2025
- Registration
- HR-H-052134264
- Marketing authorisation holder
- Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska
- Manufacturer
- Salutas Pharma GmbH, Barleben, Njemačka Pharmadox Healthcare Limited, Paola, Malta Lek Pharmaceuticals d.d., Ljubljana, Slovenija
- ATC code
- L01EA04
- Procedure
- National, MRP or DCP
- Supply
- na recept; u ljekarni