REGAFFAIRS AI
ANSWERS · 4 OCT 2026

Is apixaban (Eliquis) approved in Switzerland, Japan and Canada? Give the authorisation holder, approval date and product or registration numbers from Swissmedic, PMDA and Health Canada, with citations.

Yes. Apixaban is approved in all three countries, and the originator Eliquis is held by Bristol-Myers Squibb companies. The first approvals were Switzerland on 26 August 2011, Canada on 16 December 2011 and Japan on 25 December 2012.

Approach: I searched the Swissmedic register of authorised medicinal products, PMDA's English list of approved new drugs, and Health Canada's Drug Product Database (DPD) and Notice of Compliance (NOC) database. The PMDA list does not include the Japanese marketing approval numbers.

Switzerland (Swissmedic)Japan (PMDA/MHLW)Canada (Health Canada)
ProductEliquis, Filmtabletten (film-coated tablets), ATC B01AF02, human medicine, dispensing category B [1]Eliquis Tablets 2.5 mg and 5 mg [2]ELIQUIS, film-coated, human [3][4]
HolderHolder ID 1100488 (the register gives only an ID, not the company name) [1]Bristol-Myers K.K. [2]Bristol-Myers Squibb Canada [3]
First approval26 August 2011; status "Z" (authorised); validity open-ended (9999-12-31) [1]25 December 2012, as a new active ingredient for preventing ischaemic stroke and systemic embolism in non-valvular atrial fibrillation [2]NOC 16 December 2011: New Drug Submission, New Active Substance, anticoagulant [5]
NumbersAuthorisation number 61549 [1]Entry No. 29 in the PMDA approval list (a row number in the list, not the marketing approval number) [2]DIN 02377233 (drug code 86287) [3]; DIN 02397714 (drug code 88264) [4]; original NOC record 12881 [5]

Indications and later changes

  • Switzerland: Eliquis is authorised for three uses: preventing blood clots after surgery, preventing stroke and systemic embolism, and treating and preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) [1].
  • Japan: On 21 December 2015, PMDA's list records a new indication and dosage for treating venous thromboembolism (DVT and PE) and preventing its recurrence (entry No. 19) [6].
  • Canada: Bristol-Myers Squibb Canada received two indication supplements:
    • 5 December 2012: stroke and systemic embolism prevention in atrial fibrillation, together with a new 5 mg strength [7].
    • 10 November 2014: treatment of DVT and PE and prevention of their recurrence [8].
    • The latest supplement found is a product monograph safety update on 10 January 2025 [9].
  • The DPD records do not say which DIN is which strength.

Generics

  • Switzerland: I found 10 generic apixaban film-coated tablets authorised in the register. The earliest are Apixaban Spirig HC (no. 69317, 15 December 2023) [10] and Apixaban Sandoz (no. 68875, 3 August 2023) [11]. The most recent is Apixax (no. 70406, 26 May 2026) [12].
  • Canada: Generic submissions citing Eliquis as the Canadian reference product received NOCs from June 2022 onwards. Examples are Apotex (20 June 2022) [13] and Teva and Sandoz (20 September 2022) [14][15].

I can list every generic holder in Switzerland and Canada if that's useful.

SOURCES · 15

  1. [1]Eliquis, FilmtablettenSwissmedic
  2. [2]current-register-2012-12-25-no-0029 · p.138PMDA
  3. [3]86287Health Canada
  4. [4]88264Health Canada
  5. [5]NOC 12881Health Canada
  6. [6]current-register-2015-12-21-no-0019 · p.111PMDA
  7. [7]NOC 13925Health Canada
  8. [8]NOC 16273Health Canada
  9. [9]NOC 34680Health Canada
  10. [10]Apixaban Spirig HC, FilmtablettenSwissmedic
  11. [11]Apixaban Sandoz, FilmtablettenSwissmedic
  12. [12]Apixax, FilmtablettenSwissmedic
  13. [13]ELIQUISHealth Canada
  14. [14]ELIQUISHealth Canada
  15. [15]ELIQUISHealth Canada
Continue this research.
Ask a follow-up; this answer comes along as context.
More published answers →