Tibsovo 250 mg Tablet (Immediate Release) is a Health Canada–registered human drug (DIN 02549980) held by Servier Canada Inc, containing Ivosidenib. Health Canada lists its status as Marketed (status date 28 Oct 2024). Nexara Health has matched 28 registrations of Ivosidenib across 24 other regulated markets, 16 of them in the same strength and dosage form.
Health Canada registration
| DIN | 02549980 |
|---|---|
| Brand name | Tibsovo |
| Active ingredient | Ivosidenib |
| Strength | 250 mg |
| Dosage form | Tablet (Immediate Release) |
| Route | Oral |
| Company | Servier Canada Inc |
| Status | Marketed — 28 Oct 2024 |
| Class | Human |
| ATC | |
| AHFS | |
| Regulator record | Health Canada DPD entry · Product monograph |
Ivosidenib registered in other markets
28 registrations of the same molecule in 24 national registries outside Canada. Each row is taken from the regulator's own published list; status is shown as the registry reports it.
| Country | Product | Marketing authorisation holder | Strength | Form | Status | Registry |
|---|---|---|---|---|---|---|
| Czech Republic | Tibsovo | — | 250MG | Tbl Flm | R | SUKL DLP |
| Denmark | Tibsovo | Les Laboratoires Servier | 250 mg | filmovertrukne tabletter | Central | Laegemiddelstyrelsen |
| Finland | Tibsovo | Les Laboratoires Servier | 250 mg | tabletti, kalvopäällysteinen | Myyntilupa myönnetty | Fimea Perusrekisteri |
| Hong Kong | Tibsovo Film-Coated Tablets 250mg | Servier Hong Kong Limited | Registered | DH Drug Office | ||
| Hungary | Tibsovo 250 mg Filmtabletta | Les Laboratories Servier | 60x hdpe tartályban | NEAK PUPHA | ||
| Ireland | Tibsovo 250 mg Film-coated tablet | Les Laboratoires Servier | Film-coated tablet | Unknown | HPRA | |
| Netherlands | Tibsovo 250 mg, filmomhulde tabletten | Les Laboratoires Servier | Filmomhulde tablet | Uitsluitend recept | EU national register | |
| Norway | Tibsovo tab 250 mg | Les Laboratoires Servier | 60 | Tablett | Aktiv oppføring | FEST (DMP) |
| Poland | Tibsovo | Les Laboratoires Servier | 250 mg | Tabletki powlekane | URPL RPL | |
| Romania | TIBSOVO 250 mg | — | 250mg | Compr. Film. | PR | ANMDMR nomenclator |
| Singapore | Tibsovo Film-Coated Tablet 250mg | Servier (S) Pte Ltd | 250.0mg | Tablet, Film Coated | Prescription Only | HSA |
| Slovakia | Tibsovo 250 mg filmom obalené tablety | Sve-2 | tbl flm 60x250 mg (fľ.HDPE) | O | MZ SR kategorizacia | |
| Slovenia | Tibsovo 250 mg film.obl.tbl. 60x | — | P* | CBZ | ||
| Taiwan | TIBSOVO film-coated tablets 250mg | 裕利股份有限公司 | 膜衣錠 | Registered | TFDA | |
| United Arab Emirates | TIBSOVO® 250 mg | LES LABORATOIRES SERVIER INDUSTRIE, France, Gidy | 250 mg/tablet | Tablet | Active | EDE |
| United Kingdom | Ivosidenib 250mg tablets | — | 0001 | NHS dm+d VMP | ||
| Australia | Tibsovo | Se | Tablet 250 mg | GE | PBS | |
| European Union (EMA) | Tibsovo | Les Laboratoires Servier | Authorised | EMA centrally authorised | ||
| European Union (EMA) | Tibsovo | Agios Netherlands B.V. | Application withdrawn | EMA centrally authorised | ||
| European Union (EMA) | Tidhesco | Les Laboratoires Servier | Application withdrawn | EMA centrally authorised | ||
| Greece | Tibsovo F.c.tab 250mg/Ταβ Φιαλη (Hdpe) Χ 60 Δισκια | Les Laboratoires Servier France | reimbursed | MoH deltio timwn | ||
| Iceland | Tibsovo | Icepharma - óskráð | 250 mg | töflur | 0 | Lyfjastofnun lyfjaverdskra |
| Italy | TIBSOVO*60 cpr rivestite 250 mg flacone | Les Laboratoires Servier | IVOSIDENIB 250MG 60 UNITA' USO ORALE | Classe H | AIFA liste A/H | |
| Luxembourg | Tibsovo CPR.PELLIC. 250 mg 1*60 cpr.(flacon PEHD) | — | RR | CNS liste positive | ||
| Saudi Arabia | Tibsovo | — | 250 | Inactive | SFDA | |
| United States | ivosidenib | Patheon Inc. | Tablet, Film Coated | FDA NDC | ||
| United States | Ivosidenib | Dottikon Exclusive Synthesis AG | Powder | FDA NDC | ||
| United States | Tibsovo | Servier Pharmaceutical LLC | Tablet, Film Coated | listed | FDA NDC |
See every manufacturer of Ivosidenib worldwide →
Regulator price references for Ivosidenib
Published list or reimbursement prices for Ivosidenib presentations, in local currency, as at the date each registry last published. These are public reference prices, not Nexara Health quotes; strength and pack differ by row.
| Country | Product | Strength | Pack | Price | Type | Source | As of |
|---|---|---|---|---|---|---|---|
| Hungary | Tibsovo 250 mg Filmtabletta | 250mg | 60x hdpe tartályban | 4,250,338.00 HUF | producer price (ex-factory) | NEAK PUPHA | 2026-09-03 |
| Norway | Tibsovo | 250mg | 60 stk | 210,773.90 NOK | max AUP (pharmacy retail) | DMP (Statens legemiddelverk) maksimalpris | 2026-09-07 |
| Slovakia | Tibsovo 250 mg filmom obalené tablety | 250mg | tbl flm 60x250 mg (fľ.HDPE) | 11,591.14 EUR | categorised final price | MZ SR kategorizacia | 2026-09-02 |
| United Arab Emirates | TIBSOVO® 250 mg | 250mg | 60's HDPE Bottle | 149,041.00 AED | public | EDE | 2026-08-31 |
| Australia | Tibsovo | Tablet 250 mg | 19,920.00 AUD | ex-manufacturer | PBS | 2026-09-08 | |
| Greece | Tibsovo F.c.tab 250mg/Ταβ Φιαλη (Hdpe) Χ 60 Δισκια | 250mg | 13,238.24 EUR | producer price (ex-factory) | MoH deltio timwn | 2026-09-03 | |
| Iceland | Tibsovo | 250mg | glas | 2,306,525.00 ISK | max wholesale | Lyfjastofnun lyfjaverdskra | 2026-09-02 |
| Italy | TIBSOVO*60 cpr rivestite 250 mg flacone | 250mg | IVOSIDENIB 250MG 60 UNITA' USO ORALE | 12,454.50 EUR | ex-factory (classe H) | AIFA liste A/H | 2026-09-02 |
| Luxembourg | Tibsovo CPR.PELLIC. 250 mg 1*60 cpr.(flacon PEHD) | 250mg | 14,214.00 EUR | reimbursement | CNS liste positive | 2026-09-05 | |
| Saudi Arabia | Tibsovo | 78,081.35 SAR | public | SFDA | 2026-09-01 |
Sourcing through Nexara Health
Nexara Health is a Health Canada–licensed wholesaler (DEL #3-002896) in Winnipeg. Because this DIN is marketed in Canada, supply normally comes through the Canadian channel; where the Canadian presentation is short or discontinued, the registrations above show which regulated markets hold an equivalent that can be imported under the Special Access Programme or for clinical comparator use. Request a quote or read how named-patient and foreign-pack supply works in Canada.
Frequently asked questions
Is Tibsovo (DIN 02549980) marketed in Canada?
Yes. Health Canada lists DIN 02549980 as Marketed as of 28 Oct 2024.
Who holds the Canadian licence for this product?
Servier Canada Inc is the company of record in the Health Canada Drug Product Database.
Is Ivosidenib registered outside Canada?
Yes — Nexara Health has matched 28 registrations in 24 other markets, including 16 in the same strength and dosage form (see the table above).
Where does this data come from?
Health Canada Drug Product Database (DPD), DIN 02549980, status date 2024-10-28; national medicine registries: AIFA liste A/H, ANMDMR nomenclator, CBZ, CNS liste positive, DH Drug Office, EDE, EMA centrally authorised, EU national register, FDA NDC, FEST (DMP), Fimea Perusrekisteri, HPRA, HSA, Laegemiddelstyrelsen, Lyfjastofnun lyfjaverdskra, MoH deltio timwn, MZ SR kategorizacia, NEAK PUPHA, NHS dm+d VMP, PBS, SFDA, SUKL DLP, TFDA, URPL RPL; price sources: AIFA liste A/H, CNS liste positive, DMP (Statens legemiddelverk) maksimalpris, EDE, Lyfjastofnun lyfjaverdskra, MoH deltio timwn, MZ SR kategorizacia, NEAK PUPHA, PBS, SFDA. Nexara Health re-checks these sources weekly and shows the last verification date at the top of the page.
Source: Health Canada Drug Product Database (DPD), DIN 02549980, status date 2024-10-28; national medicine registries: AIFA liste A/H, ANMDMR nomenclator, CBZ, CNS liste positive, DH Drug Office, EDE, EMA centrally authorised, EU national register, FDA NDC, FEST (DMP), Fimea Perusrekisteri, HPRA, HSA, Laegemiddelstyrelsen, Lyfjastofnun lyfjaverdskra, MoH deltio timwn, MZ SR kategorizacia, NEAK PUPHA, NHS dm+d VMP, PBS, SFDA, SUKL DLP, TFDA, URPL RPL; price sources: AIFA liste A/H, CNS liste positive, DMP (Statens legemiddelverk) maksimalpris, EDE, Lyfjastofnun lyfjaverdskra, MoH deltio timwn, MZ SR kategorizacia, NEAK PUPHA, PBS, SFDA.
Health Canada Drug Product Database (DPD), DIN 02549980, status date 2024-10-28; national medicine registries: AIFA liste A/H, ANMDMR nomenclator, CBZ, CNS liste positive, DH Drug Office, EDE, EMA centrally authorised, EU national register, FDA NDC, FEST (DMP), Fimea Perusrekisteri, HPRA, HSA, Laegemiddelstyrelsen, Lyfjastofnun lyfjaverdskra, MoH deltio timwn, MZ SR kategorizacia, NEAK PUPHA, NHS dm+d VMP, PBS, SFDA, SUKL DLP, TFDA, URPL RPL; price sources: AIFA liste A/H, CNS liste positive, DMP (Statens legemiddelverk) maksimalpris, EDE, Lyfjastofnun lyfjaverdskra, MoH deltio timwn, MZ SR kategorizacia, NEAK PUPHA, PBS, SFDA. Last reviewed 2026-09-16. Nexara Health is a licensed wholesaler and supplies licensed entities only; consumer orders are routed to a partner pharmacy.