Ocaliva 5 mg, Filmtabletten

7680665300016 CH-66530 Filmtabletten
Ocaliva 5 mg, Filmtabletten
Ocaliva 5 mg, Filmtabletten
Ocaliva 5 mg, Filmtabletten
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Article details

Package size
30
Selling units
30
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
24/11/2022
Patient information leaflet
Français
24/11/2022
Patient information leaflet
Italien
24/11/2022
Summary of Product Characteristics
Allemand
24/11/2022
Summary of Product Characteristics
Français
24/11/2022
Summary of Product Characteristics
Italien
24/11/2022

Detailed composition

Substance Quantity Type Category
(N/A)
5.0 MG Substance Wirkstoff (Principe actif)

Authorization holder

Advanz Pharma Specialty Medicine

8048 Zürich

Authorization information

Swissmedic authorization number
66530
Drug name
Ocaliva, Filmtabletten
Galenic form
FILM
ATC Code
A05AA04
Authorization status
Revoked/Withdrawn
Dispensing category
B
First authorization
01/06/2018
Authorization expiration date
19/08/2025
IT Number
04.99.0.
Domain
Human medicine
Field of application
Primäre biliäre Cholangitis (PBC)

Package details

Description (FR)
OCALIVA cpr pell 5 mg bte 30 pce
Description (DE)
OCALIVA Filmtabl 5 mg Ds 30 Stk
Market launch
01/06/2018
Market withdrawal
19/08/2025
Narcotic (BTM)
No

Other package sizes (1)

OCALIVA cpr pell 10 mg bte 30 pce
30 TABL
GTIN: 7680665300023
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