Swissmedic Vigilance News

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21.06.2023 Medicinal products with a medical device component (combination products) Implementation of the transitional provisions for medical devices 15.06.2023 Modification of the Guidance document Authorisation of homeopathics, anthroposophics and other complementary medicinal products Content-related clarifications and additions to the guidance document, including on the declaration, on packaging texts and on details in the patient information 13.06.2023 Swissmedic publishes its Annual Report for 2022 On 9 June 2023 the Federal Council approved Swissmedic's Annual Report for 2022 01.06.2023 Delayed implementation time limits for replacement changes Changes to the guidance documents Variations and Extensions HMP and Variations VMP 01.06.2023 Changes to guidance document Fast-track authorisation procedure and guidance document Temporary authorisation for human medicinal products Exchange of documentation for the AAA now possible via the eGov portal The complete list is available at the following web address: www.swissmedic.ch/updates-en Swissmedic Vigilance News | Edition 31 – November 2023 50
Schweizerisches Heilmittelinstitut Institut suisse des produits thérapeutiques Istituto svizzero per gli agenti terapeutici Swiss Agency for Therapeutic Products Swissmedic, Swiss Agency for Therapeutic Products Safety of Medicines Division Hallerstrasse 7 3012 Bern Schweiz www.swissmedic.ch
Page 1 and 2: Vigilance News Edition 31 - Novembe
Page 3 and 4: In this edition 5 Editorial 6 Safet
Page 5 and 6: Editorial Dear Reader Recently, a r
Page 7 and 8: exposed to non-teratogenic drugs. D
Page 9 and 10: Results Between January 2022 and Ju
Page 11 and 12: Among those cases in which drug cau
Page 13 and 14: (7) Swissmedic. Drug-induced pancre
Page 15 and 16: hyperlipidaemia, diabetes, coronary
Page 17 and 18: when treated with IVT is high, all
Page 19 and 20: Febuxostat and azathioprine: A rare
Page 21 and 22: professionals for Imurek ® does no
Page 23 and 24: COVID-19 vaccines: Is the seriousne
Page 25 and 26: A total of 4,125 reports (37% of al
Page 27 and 28: proportion of serious cases (12, 13
Page 29 and 30: Kounis syndrome: A less familiar ad
Page 31 and 32: Conclusion Diagnosing Kounis syndro
Page 33 and 34: As an example, we calculated the RO
Page 35 and 36: In summary, Swissmedic would like t
Page 37 and 38: Update to the guidance document “
Page 39 and 40: Vaccinovigilance Valeriu Toma Safet
Page 41 and 42: Serious Medically important/Serious
Page 43 and 44: 140 130 120 110 Non-serious Serious
Page 45 and 46: Vigilance for veterinary medicinal
Page 47 and 48: Healthcare Professional Communicati
Page 49: 22.09.2023 Swissmedic approves Pfiz

Swissmedic Vigilance News

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