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15.07.2026

DHPC – Primovist 0.25 mmol/ml (dinatrii gadoxetas)

Zusätzliche visuelle Kontrolle

14.07.2026

DHPC – Fungizone, Injektionspräparat (i.v.) (amphotericinum B)

Verzögerte Implementierung der zuletzt genehmigten Packungsbeilage (Stand Februar 2025) mit neuem Warnhinweis zu Hyperkaliämie

14.07.2026

New information on the introduction of eCTD v4.0

Swissmedic will complete technical implementation of eCTD v4.0 by the end of 2026 and is now publishing version 1.1 of the package for the Swiss Implementation Guide

13.07.2026

Out-of-Stock – Voranigo 10 mg, Filmtabletten

Befristete Bewilligung zum Vertrieb in irischer Aufmachung

10.07.2026

DHPC – Domperidon axapharm lingual®, Domperidon lingual Spirig HC®, Domperidon-Mepha® oro, Motilium®, Motilium lingual®, Motilium lingual Gastrosan® (Domperidon)

Domperidonhaltige Arzneimittel: Neue Kontraindikation Phäochromozytom

10.07.2026

Summary report on authorisation – Enflonsia®

First authorisation

09.07.2026

DHPC – Ontozry (Cenobamat)

Risiko für schweren Leberschaden und neue Empfehlungen zur Überwachung der Leberfunktion

09.07.2026

DHPC – Konakion MM paediatric / Konakion MM (phytomenadionum)

Glasartige Partikel nach dem Öffnen von Konakion MM-Ampullen

09.07.2026

Out-of-Stock – Opdualag 240mg/80mg, Konzentrat zur Herstellung einer Infusionslösung

Befristete Bewilligung zum Vertrieb in französischer Aufmachung

08.07.2026

Swissmedic Journal

Latest edition
Swissmedic Journal June 2026

07.07.2026

Leiterin / Leiter Direktionsstab (80 - 100%)

Job advertisement | Direktionsstab

06.07.2026

CIRS study on authorisation times for human medicinal products with new active substances confirms Swissmedic’s competitiveness internationally

International authorisation times for human medicinal products with new active substances during the period 2016–2025

03.07.2026

Summary report on authorisation – Ezmekly®

First authorisation

03.07.2026

Summary report on authorisation – Paxlovid®

Indication extension (01)

01.07.2026

Revision of the Guidance document Packaging texts for veterinary medicinal products

ZL000_00_029e

01.07.2026

TPLRO, TPLO: Update of annexes

Update of the TPLRO and TPLO annexes

01.07.2026

swissdamed: As of 1 July 2026, mandatory registration applies to medical devices and in vitro diagnostic medical devices

New requirements for manufacturers and authorised representatives

01.07.2026

Patient information and Information for healthcare professionals for human medicinal products: Change to the templates

Change to the Patient information and Information for healthcare professionals templates

01.07.2026

Fassung 12.3 der Europäischen Pharmakopöe in Kraft

Der Institutsrat hat die Fassung 12.3 der Europäischen Pharmakopöe auf den 1. Juli 2026 in Kraft gesetzt

01.07.2026

Safety Update – product information updates

Important new safety information in professional information – overview July 2026

30.06.2026

Cross-agency targeted campaign "Peptides 2026"

Swissmedic and SSI warn of the health risks associated with illegally imported peptides and conduct a joint campaign with FOCBS

25.06.2026

DHPC – Miostat (carbacholum)

Abweichung in den Packungsmaterialien (Faltschachtel, Blister; Etikette, Packungsbeilage)

25.06.2026

Chargenrückruf – Mycostatin, Suspension zum Einnehmen 100'000 I.E./ml

Rückzug der Charge 55234 bis auf Stufe Patient

23.06.2026

Out-of-Stock – Betaseptic, alkoholische Povidon-Iod-Lösung 1000 ml

Befristete Bewilligung zum Vertrieb in deutscher Aufmachung

23.06.2026

Summary report on authorisation - Enhertu®

Extension of therapeutic indication (06)

22.06.2026

DHPC – MisoOne (misoprostolum)

Wichtige Sicherheitsinformation

22.06.2026

Summary report on authorisation – Winrevair®

Indication extension (01)

22.06.2026

Summary report on authorisation – Breyanzi®

Extension of therapeutic indication (02)

22.06.2026

Summary report on authorisation – mRESVIA®

Extension of therapeutic indication (01)

22.06.2026

Meeting of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

The Assembly of the ICH met in person on 2–3 June 2026 in Rio de Janeiro, Brazil, for its biannual meeting

19.06.2026

New options for registering devices in swissdamed: Online editor, Machine-to-Machine (M2M) interface, and Master UDI-DI registration

Thanks to a user-friendly online editor and a M2M interface, the registration process in the UDI Devices module is simpler, faster, and better adapted to different user needs. The registration of contact lenses that require a Master UDI-DI is now also supported.

19.06.2026

Revision of the Swissmedic Fees Ordinance on 1 July 2026

New fee schedule for charging by time

19.06.2026

Chargenrückruf – Fixaprost, Augentropfen Einzeldosen

Rückzug der Charge 3X74 bis auf Stufe Patient

18.06.2026

Updated information sheet about the requirements for the maintenance of sterilization containers

The information sheet on the requirements for the maintenance of sterilization containers has been updated and further detailed

18.06.2026

Revised annex 3a TPLRO

Polysorbates as excipients of particular interest

15.06.2026

Senior Controller/in (80 - 100%)

Stellenausschreibung | Finanzen und Controlling

15.06.2026

DHPC – Menopur Multidose (menotropinum)

Wichtige Mitteilung zur Arzneimittelsicherheit

15.06.2026

SEND datasets for new authorisation applications for human medicinal products with new active substances

Submission will be mandatory from 15 June 2026

12.06.2026

Swissmedic publishes its Annual Report and financial statements for 2025

Federal Council approves Swissmedic’s Annual Report and financial statements

09.06.2026

DHPC – Tigecyclin Leman (tigecyclinum)

Abweichung zwischen dem im 2D-Barcode auf der Umverpackung kodierten Verfallsdatum und dem lesbaren Verfallsdatum
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