Balversa 4 mg, Filmtabletten

7680676600037 CH-67660 Filmtabletten
Balversa 4 mg, Filmtabletten
Fiches Amavita / Sun Store / Coop Vitality

Article details

Package size
28
Selling units
28
Measure
Tablette(n)
Galenic form
Filmtabletten
Galenic group
Tabletten

Official Swissmedic V2 data

Additional information from the official database

Official medical documents

Patient information leaflet
Allemand
18/11/2025
Patient information leaflet
Français
18/11/2025
Patient information leaflet
Italien
18/11/2025
Summary of Product Characteristics
Allemand
13/11/2025
Summary of Product Characteristics
Français
13/11/2025
Summary of Product Characteristics
Italien
13/11/2025

Detailed composition

Substance Quantity Type Category
erdafitinibum
4.0 MG Substance Wirkstoff (Principe actif)
mannitolum
- Substance HNIDK
cellulosum microcristallinum
- Substance HNIDK
megluminum
- Substance HNIDK
carmellosum natricum conexum
- Substance HNIDK
magnesii stearas
- Substance HNIDK
poly(alcohol vinylicus)
- Substance HNIDK
E 171
- Substance FNIDK
talcum
- Substance HNIDK
E 172 (flavum)
- Substance FTODK
E 172 (rubrum)
- Substance FTODK
glyceroli monocaprylocapras
- Substance HNIDK
natrii laurilsulfas
- Substance Hilfsstoff ohne Deklarationspflicht (Excipient sans obligation de déclaration)
natrium
0.44 MG Substance HBESI

Reimbursement information

Public price
CHF 9209.20
Specialties list
Yes
Generic
No

Reimbursement limitation

SL addition date: 01/07/2025

Authorization holder

Janssen-Cilag AG

6300 Zug

Authorization information

Swissmedic authorization number
67660
Drug name
Balversa, Filmtabletten
Galenic form
FILM
ATC Code
L01EN01
Authorization status
Z
Dispensing category
A
First authorization
14/01/2025
Authorization expiration date
13/01/2030
IT Number
07.16.1.
Domain
Human medicine
Field of application
Behandlung erwachsener Patienten mit Urothelkarzinom (UC)

Package details

Description (FR)
BALVERSA cpr pell 4 mg bte 28 pce
Description (DE)
BALVERSA Filmtabl 4 mg Ds 28 Stk
Market launch
24/04/2025
Narcotic (BTM)
No

Other package sizes (4)

BALVERSA cpr pell 3 mg bte 56 pce
56 TABL
GTIN: 7680676600013
View
BALVERSA cpr pell 3 mg bte 84 pce
84 TABL
GTIN: 7680676600020
View
BALVERSA cpr pell 4 mg bte 56 pce
56 TABL
GTIN: 7680676600044
View
BALVERSA cpr pell 5 mg bte 28 pce
28 TABL
GTIN: 7680676600051
View
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