ZEPZELCA subst sèche 4 mg flac

7680677290015 CH-67729 L01XX69 07.16.1.

Active substances:

ZEPZELCA subst sèche 4 mg flac
ZEPZELCA subst sèche 4 mg flac
ZEPZELCA subst sèche 4 mg flac
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Details

Product number
6772901
CPT
-
Packaging group
-
Unit
Durchstechflasche(n)
Composition
lurbinectedinum 4 mg, saccharum, acidum lacticum, natrii hydroxidum corresp. natrium 2.94 mg, pro vitro.

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Professional SmPC
Allemand
05/02/2026
Professional SmPC
Français
05/02/2026
Professional SmPC
Italien
05/02/2026

Detailed composition

Substance Quantity Type Category
lurbinectedinum
4.0 MG Substance Wirkstoff (Principe actif)
saccharum
- Substance HNIDK
acidum lacticum
- Substance HNIDK
natrii hydroxidum
- Substance HNIDK
natrium
2.94 MG Substance HBESI

Reimbursement information

Public price
CHF 5790.50
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/09/2023

Authorization holder

PharmaMar AG

4051 Basel

Authorization information

Swissmedic authorization number
67729
Drug name
Zepzelca, Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Galenic form
PULPI
ATC Code
L01XX69
Authorization status
Z
Dispensation category
A
First authorization
07/03/2023
Authorization expiration date
19/11/2030
IT number
07.16.1.
Domain
Human medicine
Field of application
ZEPZELCA ist zur Behandlung von erwachsenen Patienten mit metastasiertem kleinzelligem Lungenkarzinom (SCLC) und als Erhaltungstherapie bei erwachsenen Patienten mit kleinzelligem Lungenkarzinom im extensiven Stadium (ES-SCLC) indiziert.

Packaging details

Description (FR)
ZEPZELCA subst sèche 4 mg flac
Description (DE)
ZEPZELCA Trockensub 4 mg Durchstf
Market launch
07/03/2023
Narcotic (BTM)
No
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