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New on this website

20.02.2026

New in the swissdamed playground: Machine-to-Machine product registration

M2M registration can be tested on the swissdamed playground environment starting end of March 2026

20.02.2026

Authorisation of complementary and herbal medicinal products 2025

First-time authorisation of a herbal medicinal product with orphan drug status

18.02.2026

DHPC – Cytosar (cytarabinum)

Diskrepanz Barcode

17.02.2026

Authorisations of human medicinal products with a new active substance and additional indications 2025

40 human medicinal products with new active substances authorised

16.02.2026

Batch recall – Verkazia Augentropfen Emulsion

Rückzug der Charge 4T98H bis auf Stufe Detailhandel

16.02.2026

Software-Architect (80-100%)

Job advertisement | Abteilung Informatik

16.02.2026

Cloud Engineer (80-100%)

Stellenausschreibung | Abteilung Informatik

16.02.2026

Illegal imports of medicinal products in 2025: more consignments, new products trends and increasing shipments from the EU

17 percent more illegal imports of medicinal products recorded than in 2024

13.02.2026

Summary report on authorisation – Ekterly®

First authorisation

11.02.2026

DHPC – Irbesartan Spirig HC (irbesartanum)

Textfehler auf der Faltschachtel

10.02.2026

New in swissdamed

“Legacy devices” registration now available

09.02.2026

Batch recall – Benocten Tropfen zum Einnehmen, Lösung

Rückzug der Chargen 210013, 210023, 210014, 210024 und 2100125 bis auf Stufe Detailhandel

09.02.2026

Summary report on authorisation – Fabhalta®

Extension of therapeutic indication (01)

06.02.2026

Jarisch-Herxheimer reaction during antibiotic treatment of spirochaetal infections

Learning from adverse reaction reports – cases from pharmacovigilance

05.02.2026

Batch recall – Similasan Schlafstörungen Globuli

Rückzug der Charge 17911 bis auf Stufe Patient

05.02.2026

Out-of-Stock – Nemluvio Pulver und Lösungsmittel zur Herstellung einer Injektionslösung im Fertigpen

Befristete Bewilligung zum Vertrieb in deutscher Aufmachung

04.02.2026

Swissmedic Journal

Latest edition
Swissmedic Journal Januar 2026

02.02.2026

Significant violations in the use of medical devices for wrinkle treatment (‘fillers’)

The results of this year's focus campaign by the cantonal therapeutic products authorities and Swissmedic clearly demonstrate how important qualified medical professionals and product conformity are for consumer safety.

01.02.2026

Updating of Annex 7 TPLRO – Revised list of variations

A revised list of variations according to Articles 21-24 TPO comes into force on 1 February 2026

01.02.2026

Changes to the Guidance document Drug Safety Signals HMP and the Signal Notification Form

The Guidance document Drug Safety Signals HMP has been comprehensively revised, its structure has been modified and its content has been clarified; in parallel, the Signal Notification Form has been revised and adapted to the new requirements

01.02.2026

Archiving of information sheets on specimen texts for medicinal product information for analgesics

The information sheets on specimen texts for medicinal product information for paracetamol, acetylsalicylic acid and NSAIDs are to be archived

30.01.2026

Swiss Pharmacopoeia

from recipe book to mandatory quality standard

30.01.2026

Market surveillance of medical devices

Results of a Swissmedic focus campaign of importers

30.01.2026

Summary report on authorisation – Alyftrek®

First authorisation

30.01.2026

Summary report on authorisation – Obgemsa®

First authorisation

30.01.2026

Version 2.1 of the «Schweizerische Gute Praxis für die Instandhaltung von Medizinprodukten» (GPI)

GPI version 2.0 have been updated to Version 2.1. This revision clearly reflects the requirements set out in Art. 71 para. 2 MedDO and Art. 64 para. 2 IvDO. Details can be found in the document's change history.

29.01.2026

Summary report on authorisation – Nubeqa®

Extension of therapeutic indication (02)

28.01.2026

DHPC – Ocrevus® (Ocrelizumab)

Leberschädigung mit Ocrelizumab

27.01.2026

Summary report on authorisation – Hepcludex®

Extension of therapeutic indication (01)

23.01.2026

DHPC – Arixtra® (fondaparinuxum natricum)

Ernsthafter Qualitätsmangel im Zusammenhang mit der Nadel der vorgefüllten Spritze

22.01.2026

Batch recall – Risperidon-Mepha LA Pulver und Lösungsmittel zur Herstellung einer Suspension zur i.m. Injektion

Rückzug der Chargen 4400869, 4400443, 4400446 und 4401766 bis auf Stufe Detailhandel

21.01.2026

Application for authorisation of a medicinal product with integral medical device component (integral combination product)

Requirements regarding a Notified Body Opinion

19.01.2026

Summary report on authorisation – Amvuttra®

Extension of therapeutic indication (01)

15.01.2026

Summary report on authorisation – Calquence®

Extension of therapeutic indication (01)

15.01.2026

Redundancy scheme for announced headcount reduction at Swissmedic approved

Agreement will permit socially acceptable implementation of staff reduction

13.01.2026

Reassessment of the safety of blood transfusions with regard to vCJD

New blood donation criteria from Swiss Transfusion SRC effective 1 February 2026

13.01.2026

Out-of-Stock – Abilify i.m. Injektionslösung 7.5mg/ml

Befristete Bewilligung zum Vertrieb in deutscher Aufmachung

12.01.2026

swissdamed Webinar: How to register and manage medical device data in swissdamed

On 28 May 2026, Swissmedic is hosting a free online training on how to register medical devices in swissdamed

12.01.2026

Change in Swissmedic top management: Executive Director Vincenza Trivigno takes up her post

On 12 January 2026, Vincenza Trivigno will take up her post as Executive Director of Swissmedic

08.01.2026

Batch recall – Locametz 25 mcg Mehrfachdosis-Kit für ein radioaktives Arzneimittel

Rückzug der Chargen PG21CH2507 und PG21CH2508 / Bulk Batch ID: F0392504 bis auf Stufe Detailhandel (Klinik / Spital)
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