DHPC – Tecentriq (ATEZOLIZUMAB)

Medicinal products may only be distributed in Switzerland if they are authorised by Swissmedic. The Swiss Agency for Therapeutic Products, is involved in the entire life cycle of a medicinal products because of its mandated areas of responsibility in the sectors of licensing and the authorisation and monitoring of medicinal products.

The Veterinary Medicines Department is responsible for authorisation of veterinary medicines.

It deals with the quality, safety and efficacy of veterinary medicines in the context of new applications, extensions and variations.

Authorisation documentation for veterinary medicines is assessed by internal and external experts as well as the VMEC.

The Department regularly coordinates regulatory issues and similar concerning the supply of veterinary medicines in roundtable meetings with the Swiss veterinary pharmaceuticals industry, representatives of veterinarians and the Swiss authorities, such as the Federal Food Safety and Veterinary Office (FSVO).

Exchanging views with national and international authorities on veterinary medicine-specific issues is important, so use is made of this dialogue whenever required.

The Veterinary Medicines Department performs further monitoring in the area of veterinary medicines, processes notifications of adverse reactions and comments on safety-relevant topics such as illegal imports and delimitation questions.

Complementary and herbal medicines are very popular and widely used in Switzerland. These medicinal products can be authorised using a simplified procedure on the basis of the legislation governing therapeutic products in Switzerland and the Ordinance on Complementary and Herbal Medicinal Products (SR 812.212.24) in particular. Swissmedic ensures that the fundamental requirements for authorisation of these medicines are fulfilled.

Unlike medicinal products, medical devices do not undergo an official authorisation procedure. Swissmedic's focus in the area of medical devices is thus on effective market surveillance.

Swissmedic is the national authorisation and supervisory authority for drugs and medical products. The agency ensures that only high-quality, safe and effective medical products are available in Switzerland, thus making an important contribution to the protection of human and animal health.

immunbedingte Myokarditis

28.07.2017 - In Absprache mit Swissmedic informiert die Zulassungsinhaberin, Roche Pharma (Schweiz) AG:

Bei Krebspatienten, die in klinischen Studien eine Behandlung mit Tecentriq® erhalten haben, wurde über Fälle von Myokarditis berichtet. In einer kumulativen Analyse der Sicherheitsdatenbank des Unternehmens wurden 2 nicht-tödliche Fälle von Myokarditis identifiziert; bei einem Patienten wurde die Diagnose einer immun-vermittelten Myokarditis durch eine Biopsie bestätigt. Die Analyse umfasste Daten aus klinischen Studien und aus der Anwendungsbeobachtung nach der Markteinführung, die bis zum 20. Februar 2017 erfasst wurden. Bislang sind ungefähr 8'000 Patienten in klinischen Studien und 5'000 Patienten nach der Markteinführung mit Tecentriq® behandelt worden.
Es wird empfohlen, Tecentriq® bei Auftreten einer Myokarditis jeglichen Grades dauerhaft abzusetzen. Falls klinisch indiziert, sollten Kortikosteroide und/oder weitere Immunsuppressiva verabreicht werden.

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DHPC – Tecentriq (ATEZOLIZUMAB)

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