RegulatoryOfficial

Estonia lists human and veterinary marketing authorisations that ended on 26 October 2026

🇪🇪 Ravimiamet · Tue 27 Oct 2026

Ravimiamet has published an overview of authorisations that lapsed at holders' request, and every product shown in the available text is marked as not marketed.

The Estonian State Agency of Medicines (Ravimiamet) published on 27 October 2026 an overview of human and veterinary marketing authorisations that ended in October. The listed authorisations expired on 26 October 2026 at the request of the marketing authorisation holders.

The human medicines table has 17 entries. They include two Proctolax macrogol sachet strengths (Casen Recordati), Aknefug-Oxid Mild (Dr. August Wolff), Vertimed 8 mg (Medochemie), Ipraalox 20 mg (Opella Healthcare France) and Fulvestrant Stada 250 mg/ml solution for injection in a syringe. Teva's Fluconazole Actavis 150 mg and Teriflunomide Teva 14 mg are also listed.

Zentiva has the largest group of human products, with five entries: Bisoprolol Zentiva 5 mg and 10 mg, Sorafenib Zentiva 200 mg, Jamesi (metformin plus sitagliptin) and Dutrozen (tamsulosin plus dutasteride). Venus Pharma accounts for four powder-for-injection products: cefuroxime 750 mg and 1.5 g, and ceftriaxone 1 g and 2 g.

The veterinary table, as far as the available text goes, covers products from Dechra Regulatory, Intervet International and Le Vet. Beheer. Entries include Laxatract, Sympagesic, two Tiasol strengths, Duplocillin LA, Nafpenzal DC, Porceptal and Cepralock, plus several vaccines such as Porcilis Ery, Bovilis BVD, Nobilis IB+ND+EDS, Nobivac Pi, Nobivac Respira Bb and Nobilis Rismavac + CA126. The source text is cut off at the Le Vet. Beheer entry for Histodine, so the full veterinary list cannot be confirmed here.

Each entry gives the authorisation number, strength, pharmaceutical form and active substances. All products shown carry "Ei" (no) in the column on whether they were marketed.

What it means for your team

  • Regulatory affairs teams should check the full Ravimiamet list against their Estonian portfolio and confirm that each lapse was an intended, holder-requested withdrawal.
  • The available entries are all flagged as not marketed, so supply impact looks limited, but market-access teams should verify this for any product they hold.
  • Quality and pharmacovigilance teams should update product registers, labelling and any national contact or reporting records for the affected authorisation numbers.
  • The available source text is truncated in the veterinary section, so veterinary teams should consult the original Ravimiamet document for the complete list.

Official source: Ravimiamet ↗

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

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