Althera Laboratories Receives Positive Outcome in Decentralized Procedure for Alrofen® (Rosuvastatin/Fenofibrate) in EU

Innovative Fixed-Dose Combination Recommended for Approval for the Treatment of Mixed Dyslipidaemia

DUBLIN, DUBLIN, IRELAND, February 10, 2026 /EINPresswire.com/ -- Althera Laboratories announces it has received a positive recommendation from the Dutch Medicines Evaluation Board (MEB), acting as the Reference Member State (RMS) in the European Decentralized Procedure (DCP), for Alrofen^® (Rosuvastatin/Fenofibrate 10mg/160mg and 20mg/160mg film-coated tablets).

This milestone marks the successful conclusion of the regulatory procedure, with the RMS and all Concerned Member States (CMS) supporting the approval of Alrofen^®.

Addressing a Critical Need in Cardiovascular Care - Alrofen^® is indicated as adjunct to diet and other non-pharmacological treatments (e.g., exercise, weight reduction) for the treatment of mixed dyslipidaemia as substitution therapy in adult patients at high cardiovascular risk adequately controlled with the individual substances given concurrently at the same dose level as in the fixed dose combination, but as separate products

Executive Commentary - "We are delighted to receive this positive outcome from the European health authorities," said Sanjeev Agarwal, CEO. "Mixed dyslipidaemia remains a challenging condition to manage, particularly in patients with high cardiovascular risk. The approval of Alrofen^® will provide physicians with a streamlined, single-pill option to manage complex lipid profiles, addressing both LDL cholesterol and triglycerides simultaneously."

About the Product - Alrofen^® combines two active mechanisms of action:
• Rosuvastatin: A statin that primarily lowers low-density lipoprotein (LDL) cholesterol.
• Fenofibrate: A fibrate that effectively reduces triglycerides and increases high-density lipoprotein (HDL).
The positive conclusion of the DCP allows Althera Labs to proceed immediately to the National Phase, where Marketing Authorizations will be issued by the individual national agencies in the coming months.

About Althera Laboratories:
Founded in 2010, Althera focuses on developing, out-licensing, manufacturing and supplying high value branded and select complex generic medicines. Althera pioneers innovative value added combinations fostering benefits throughout the value chain resulting in benefits for our partners, payers, prescribers and patients particularly in heart disease, diabetes and obesity management. Althera is headquartered in Dublin, Ireland.
Note: Above communication is a business communication and is not intended for Healthcare Professionals.

Da Luz Mathieu
Althera Laboratories
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