TEPKINLY conc inj 4 mg/0.8ml flac 0.8 ml

7680691610011 CH-69161 L01FX27 07.16.1.
TEPKINLY conc inj 4 mg/0.8ml flac 0.8 ml
TEPKINLY conc inj 4 mg/0.8ml flac 0.8 ml
TEPKINLY conc inj 4 mg/0.8ml flac 0.8 ml
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Details

Product number
6916101
CPT
-
Packaging group
1
Unit
Durchstechflasche(n)
Composition
epcoritamabum 4 mg, natrii acetas trihydricus, acidum aceticum glaciale, sorbitolum 21.84 mg, polysorbatum 80, aqua ad iniectabile q.s. ad solutionem pro 0.8 ml corresp. natrium 0.48 mg.

Articles (1)

Tepkinly 4 mg/0.8 ml, Konzentrat zur Herstellung einer Injektionslösung
Konzentrat zur Herstellung einer Injektionslösung
1
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Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
20/09/2025
Professional SmPC
Français
20/09/2025
Professional SmPC
Italien
20/09/2025

Detailed composition

Substance Quantity Type Category
(N/A)
4.0 MG Substance Wirkstoff (Principe actif)
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
21.84 MG Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
- Substance HNIDK
(N/A)
0.48 MG Substance HBESI

Authorization holder

AbbVie AG

6330 Cham

Authorization information

Swissmedic authorization number
69161
Drug name
Tepkinly 4 mg/0,8 ml, Injektionslösung
Galenic form
KOINJ
ATC Code
L01FX27
Authorization status
B
Dispensation category
A
First authorization
15/02/2024
Authorization expiration date
15/02/2026
IT number
07.16.1.
Domain
Human medicine
Field of application
Diffuses grosszelliges B-Zell-Lymphom; Follikuläres Lymphom

Packaging details

Description (FR)
TEPKINLY conc inj 4 mg/0.8ml flac 0.8 ml
Description (DE)
TEPKINLY Inj Konz 4 mg/0.8ml Durchstf 0.8 ml
Market launch
15/02/2024
Narcotic (BTM)
No

Other packaging sizes