Swiss Public Assessment Report (SwissPAR)

Dall’entrata in vigore della nuova legge sugli agenti terapeutici, Swissmedic pubblica informazioni supplementari di interesse generale in materia di agenti terapeutici. Conformemente all’art. 67 cpv. 1 LATer e alle disposizioni d’esecuzione dell’art. 68 cpv. 1 lett. e OM, Swissmedic pubblica un rapporto d’esame sintetico SwissPar per tutti i medicamenti per uso umano con nuovo principio attivo e per tutti gli espianti standardizzati la cui omologazione è stata approvata o respinta. Per le domande approvate o respinte relative all’estensione dell’indicazione dei medicamenti per uso umano, per i quali è stato pubblicato uno SwissPAR in occasione della nuova omologazione, Swissmedic pubblica un rapporto complementare. Lo SwissPAR contiene i risultati dell’esame, ma non contiene segreti commerciali o di fabbricazione del richiedente né dati personali.

Lo SwissPAR si rivolge in particolare ai professionisti del settore medico, ai rappresentanti dell’industria nonché ad altre autorità nazionali e internazionali. Viene pubblicato esclusivamente in inglese.

Il seguente elenco comprende anche SwissPAR relativi a medicamenti che nel frattempo non sono più omologati. Questi SwissPAR sono contrassegnati nella rispettiva descrizione con «non più omologati». Per un riepilogo dei medicamenti attualmente omologati cliccare qui.

Attualità

SwissPAR – Bimzelx (PDF, 829 kB, 11.12.2024)Extension of therapeutic indication (01)

SwissPAR – Bimzelx (PDF, 841 kB, 11.12.2024)Extension of therapeutic indication (02)

SwissPAR – Ervebo (PDF, 394 kB, 10.12.2024)Extension of therapeutic indication (01)

In aggiunta a SwissPAR, Swissmedic pubblica una versione breve di SwissPAR, il rapporto sintetico di omologazione. Lo scopo del rapporto sintetico di omologazione è di rendere le decisioni di omologazione di Swissmedic comprensibili e trasparenti per un vasto pubblico e di ampliare l’accesso alle informazioni rilevanti sui medicamenti.

Ordinato...

Ordinato per denominazione del medicamenti

A - C


SwissPAR – Beovu (PDF, 833 kB, 03.08.2022)Extension of therapeutic indication (01)



SwissPAR – Bimzelx (PDF, 829 kB, 11.12.2024)Extension of therapeutic indication (01)

SwissPAR – Bimzelx (PDF, 841 kB, 11.12.2024)Extension of therapeutic indication (02)


SwissPAR – Blenrep (PDF, 969 kB, 26.08.2022)First authorisation – no longer authorised


SwissPAR – Brukinsa (PDF, 896 kB, 03.11.2023)Extension of therapeutic indication (01)

SwissPAR – Brukinsa (PDF, 725 kB, 08.04.2024)Extension of therapeutic indication (02)


SwissPAR – Cablivi (PDF, 903 kB, 03.09.2021)Extension of therapeutic indication (01)


SwissPAR – COVID-19 Vaccine Janssen (PDF, 1 MB, 28.07.2022)First authorisation – no longer authorised

D - F


SwissPAR – Enhertu (PDF, 447 kB, 20.09.2022)Extension of therapeutic indication (01)

SwissPAR – Enhertu (PDF, 618 kB, 18.11.2024)Extension of therapeutic indication (02)

SwissPAR – Enhertu (PDF, 645 kB, 19.11.2024)Extension of therapeutic indication (03)



SwissPAR – Epidyolex (PDF, 1 MB, 19.10.2022)Extension of therapeutic indication (01)


SwissPAR – Ervebo (PDF, 394 kB, 10.12.2024)Extension of therapeutic indication (01)


SwissPAR – Evrysdi (PDF, 1 MB, 30.01.2023)Extension of therapeutic indication (01)


SwissPAR – Evusheld (PDF, 758 kB, 02.02.2024)Extension of therapeutic indication (01)


SwissPAR – Exkivity (PDF, 1 MB, 03.08.2022)First authorisation – no longer authorised

L - N

SwissPAR – Lumykras (PDF, 1 MB, 16.02.2022)First authorisation – no longer authorised


SwissPAR – MOUNJARO (PDF, 1 MB, 28.08.2024)Extension of therapeutic indication (01)



SwissPAR – Nubeqa (PDF, 408 kB, 30.03.2023)Extension of therapeutic indication (01)



SwissPAR – Nuvaxovid (PDF, 459 kB, 05.01.2023)Extension of therapeutic indication (01)

O - R


SwissPAR – Padcev (PDF, 700 kB, 14.11.2024)Extension of therapeutic indication (01)


SwissPAR – REGKIRONA (PDF, 1006 kB, 15.08.2022)First authorisation – no longer authorised


SwissPAR – Rinvoq (PDF, 760 kB, 31.05.2021)Extension of therapeutic indication (01)

SwissPAR – Rinvoq (PDF, 781 kB, 31.05.2021)Extension of therapeutic indication (02)

SwissPAR – Rinvoq (PDF, 1 MB, 20.01.2022)Extension of therapeutic indication (03)

SwissPAR – Rinvoq (PDF, 1 MB, 24.09.2024)Extension of therapeutic indication (04)

SwissPAR Rinvoq (PDF, 1 MB, 24.09.2024)Extension of therapeutic indication (05)


S - U


SwissPAR – Sarclisa (PDF, 779 kB, 06.09.2023)Extension of therapeutic indication (01)



SwissPAR – Spravato (PDF, 1017 kB, 20.10.2021)Extension of therapeutic indication (01)



SwissPAR – Tecartus (PDF, 442 kB, 26.09.2024)Extension of therapeutic indication (01)



SwissPAR – TEGSEDI® (PDF, 1 MB, 08.10.2024)First authorisation - no longer authorised


SwissPAR – Tenkasi (PDF, 824 kB, 24.01.2024)Extension of therapeutic indication (01)



SwissPAR – Trikafta (PDF, 849 kB, 18.11.2021)Extension of therapeutic indication (01)

SwissPAR – Trikafta (PDF, 649 kB, 30.03.2022)Extension of therapeutic indication (02)

SwissPAR – Trikafta (PDF, 1 MB, 02.10.2024)Extension of therapeutic indication (03)



SwissPAR – Trodelvy (PDF, 797 kB, 09.10.2023)Extension of therapeutic indication (01)


SwissPAR – Ultomiris (PDF, 624 kB, 16.09.2021)Extension of therapeutic indication (01)

SwissPAR – Ultomiris (PDF, 573 kB, 22.08.2022)Extension of therapeutic indication (02)

SwissPAR – Ultomiris (PDF, 814 kB, 13.12.2023)Extension of therapeutic indication (03)

V - Z


SwissPAR – Vabysmo (PDF, 1 MB, 06.08.2024)Extension of therapeutic indication (01)



SwissPAR – Vaxneuvance (PDF, 878 kB, 16.04.2024)Extension of therapeutic indication (01)



SwissPAR – Veklury (PDF, 513 kB, 18.10.2023)Extension of therapeutic indication (01)

SwissPAR – Veklury (PDF, 1 MB, 19.09.2023)Extension of therapeutic indication (02)



SwissPAR – Xofluza (PDF, 1 MB, 18.02.2022)Extension of therapeutic indication (01)

SwissPAR – Xofluza (PDF, 527 kB, 05.03.2024)Extension of therapeutic indication (02)



SwissPAR – Zeposia (PDF, 2 MB, 24.10.2022)Extension of therapeutic indication (01)