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Switzerland updates on medical device regulation and quality.

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Ocrevus Liver Damage: Swissmedic Update on Ocrelizumab Risks

On January 28, 2026, Swissmedic released a statement regarding Ocrevus (ocrelizumab), a medication used to treat multiple sclerosis. The update…

Europe

Swissmedic Approves Extension of Therapeutic Indication for Hepcludex

On January 27, 2026, Swissmedic announced the extension of the therapeutic indication for Hepcludex, a medication used to treat a…

Europe

Swissmedic Expands Indication for Amvuttra

Published January 26, 2026 The Swiss Agency for Therapeutic Products (Swissmedic) announced an extension of the therapeutic indication for Amvuttra,…

Europe

Swissmedic Introduces New Requirements for Integral Combination Products

On January 21, 2026, Swissmedic announced new requirements for the authorization of medicinal products with integral medical device components, also…

Europe

Swissmedic Batch Recall of Risperidon-Mepha LA Injection

What Changed? As of January 22, 2026, Swissmedic announced a batch recall of Risperidon-Mepha LA Pulver und Lösungsmittel zur Herstellung…

Europe

Breaking Swissmedic News: Critical Quality Issue with Arixtra® Fondaparinux Sodium Prefilled Syringe Needles

Europe

Swissmedic Approves Redundancy Plan for Headcount Reduction

Swissmedic has finalized a redundancy scheme in response to an announced staff reduction at the organization. The plan has been…

Europe

Swissmedic Expands Approval for Calquence® Therapeutic Indication

On January 15, 2026, Swissmedic officially approved an extension of the therapeutic indication for Calquence®, marking a significant regulatory development…

Europe

Temporary Authorization for Abilify i.m. Injection Solution Due to Supply Shortage

Swissmedic, Switzerland’s authority for therapeutic products, has announced the temporary authorization for the distribution of Abilify i.m. injection solution (7.5mg/ml)…

Europe

Swissmedic Confirms New Blood Donation Guidelines to Address vCJD Concerns

On February 1, 2026, new blood donation criteria from Swiss Transfusion SRC will take effect, marking a critical update in…

Europe

Swissmedic welcomes Vincenza Trivigno as new Executive Director

On January 12, 2026, Swissmedic, the Swiss agency responsible for the authorization and monitoring of therapeutic products, announced a significant…

Europe

Streamline Medical Device Registration with Swissmedic: Free Webinar Highlights swissdamed Tools

Swissmedic, Switzerland’s national agency for therapeutic products, is offering a complimentary webinar on May 28, 2026. This online session will…

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