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SAI - Detailed view
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TEGSEDI Inj Lös 284 mg/1.5ml 4 Fertspr 1.5 ml
Drug
Tegsedi, Injektionslösung in einer Fertigspritze
Tegsedi ist zur Behandlung von Polyneuropathie der Stadien 1 oder 2 bei erwachsenen Patienten mit hereditärer Transthyretin-Amyloidose (hATTR) indiziert
01.99.0. – various
HAM – Human medicine
INLFS – Solution for injection in pre-filled syringe
TGT – transplant product: gene therapy product
B – Dispensed on prescription by a physician or veterinarian (B)
D – no longer approved
5/31/2021
6/20/2024
Dosage strength
Tegsedi 284 mg, Injektionslösung in einer Fertigspritze
Tegsedi ist zur Behandlung von Polyneuropathie der Stadien 1 oder 2 bei erwachsenen Patienten mit hereditärer Transthyretin-Amyloidose (hATTR) indiziert
01
D – no longer approved
6/20/2024
Package
7680674510017
Out of trade from / since 6/20/2024
NA – No longer authorised
4 pre-filled syringe(s)
SUBC – Subcutaneous use
001
D – no longer approved
6/20/2024
Declaration
Component Solution
200 mg/ml inotersenum
natrii hydroxidum
acidum hydrochloridum
aqua ad iniectabile
acidum hydrochloridum
aqua ad iniectabile
Spezialitätenliste***
This package has been removed from the list of specialties. The displayed data correspond to the latest status.
SL
12/1/2024
2/28/2025
21638.60
None
Yes
10%
No
Authorisation holder
7601001403192
Swedish Orphan Biovitrum AG
Riehenring 182
4058 Basel (LU)
Riehenring 182
4058 Basel (LU)
Date of revision of the text
12/4/2024
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Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.