Inijaq (tofacitinib)

Where it stands

Inijaq (tofacitinib), from Gedeon Richter Plc., received a positive CHMP opinion on 2026-09-17. The records show no approval date, so the European Commission (EC) has not yet issued a decision on the record. The status is "Opinion".

The proposed indication covers adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis, and children from 2 years old with juvenile idiopathic arthritis (JIA).

The records give an expected EC decision date of 2026-11-23. This is an estimate, not an official date. It is calculated as the CHMP opinion date plus 67 days, the standard Commission decision period.

Regulatory pathway and designations

The only designation recorded is "Generic". A CHMP opinion means the product went through the EU centralised procedure. In general terms, a generic application relies on the reference medicine's established data rather than a full independent clinical programme. It usually needs to show comparability, typically through bioequivalence. The records do not state the reference product, the formulation or strengths, or the legal basis of the application.

The records list two entries for the same substance under the name Xeljanz in the EU: one "Authorised" and one "Refused". They do not say how these relate to each other, which application each refers to, or why one was refused. This should be checked against the primary EU sources before anyone draws conclusions about the reference product.

The positive opinion is a recommendation. Marketing authorisation in the EU is only granted by the EC decision, which normally follows the CHMP opinion. Until then the product cannot be marketed in the EU on this basis.

Safety and pharmacovigilance

The records contain no safety data, risk management plan details, post-authorisation commitments or product-information content for Inijaq. This analysis therefore makes no statement on its safety profile.

As general procedure, a generic's product information and risk-minimisation measures are normally aligned with those of the reference medicine. Reviewers should consult the final SmPC and EPAR once published, and the current Xeljanz product information, for any warnings, restrictions or monitoring requirements.

What to watch

The main near-term event is the EC decision, estimated for 2026-11-23. That date is an estimate based on the standard 67-day period and could differ. Confirm it against the Union Register of medicinal products.

Once authorised, check the final wording of the indications, in particular the paediatric JIA population from 2 years old, and the published product information. Also clarify the "Refused" Xeljanz entry in the records, and watch for national launch timing, which the records do not cover.