RegulatoryOfficial

PEI allows Scandinavian-labelled Hukyndra adalimumab pens on German market until January 2027

🇩🇪 Paul-Ehrlich-Institut · Fri 30 Oct 2026

The Paul-Ehrlich-Institut has let STADA supply Hukyndra 40 mg pre-filled pens in Finnish, Swedish, Norwegian and Danish packs in Germany to secure patient supply.

The Paul-Ehrlich-Institut (PEI) has permitted STADA, the marketing authorisation holder, to place Hukyndra 40 mg solution for injection in pre-filled pens on the German market with Scandinavian-language labelling. The permission runs until 20 January 2027 and rests on sections 10(1a) and 11(1c) of the German Medicines Act (AMG). The stated aim is to secure patient supply.

Hukyndra contains adalimumab, a human monoclonal antibody. The PEI lists its uses as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and non-infectious uveitis.

According to the PEI, the imported product is pharmaceutically identical to the German-labelled version and differs only in its packaging materials. The primary packaging and the leaflet are in Swedish, Finnish, Norwegian and Danish, while the pack still carries the trade name Hukyndra. A German-language package leaflet is attached to each unopened original pack with a rubber band. The German package leaflet and the summary of product characteristics can be downloaded from the PEI page.

The PEI identifies two batches: IL260085, with an expiry date of May 2029, and IL260054, expiring in April 2029. The product carries a special pharmacy central number (Sonder-PZN) of 21117976.

What it means for your team

  • QA and distribution teams should be aware that non-German packs, identified by special PZN 21117976 and batches IL260085 and IL260054, may legitimately be in the German supply chain until 20 January 2027.
  • Pharmacovigilance teams may wish to make sure that adverse event reports can be traced to these batches and the special PZN, since the packs differ from the standard German presentation.
  • Regulatory staff should note that the German package leaflet is supplied separately and attached to the pack, and that the German SmPC and leaflet are available on the PEI site.

Official source: Paul-Ehrlich-Institut ↗

Article written by VigiEye from the official source (Paul-Ehrlich-Institut). AI-assisted; check the source before acting.

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