RegulatoryOfficial

Estonia records two marketing authorisation holder changes for human medicines in October 2026

🇪🇪 Ravimiamet · Tue 03 Nov 2026

Ravimiamet's October overview lists transfers of Diclofex-type spray DICLOFLEX to Giuliani and of MIGARD tablets to Phoenix Labs Unlimited Company.

The Estonian State Agency of Medicines (Ravimiamet) has published its overview of changes to marketing authorisation holders (MAHs) for human medicines in October 2026. The list, dated 3 November 2026, contains two entries.

The first concerns DICLOFLEX, a 40 mg/g cutaneous spray solution. Ravimiamet records the MAH as changing from MIKA Pharma GmbH to Giuliani S.p.A.

The second concerns MIGARD, 2.5 mg film-coated tablets. The listed change is from Menarini International Operations Luxembourg S.A. to Phoenix Labs Unlimited Company.

The overview gives only the product name, pharmaceutical form, strength and the former and new holder. It does not state effective dates, reasons for the changes or any follow-up requirements, such as updates to packaging or product information.

What it means for your team

  • Teams handling DICLOFLEX or MIGARD in Estonia should confirm the new MAH details against their own records and the Ravimiamet list.
  • Regulatory and PV teams should check whether contact points, pharmacovigilance system documentation and safety data exchange arrangements need updating for the new holders.
  • Quality and labelling teams should check whether packaging and product information in Estonia must reflect the new MAH name, as the source gives no timelines.

Official source: Ravimiamet ↗

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

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