SAI - Detailed view

FLUDARABIN Accord Inf Konz 50 mg/2ml Durchstf

Drug

Name

Fludarabin Accord, Konzentrat zur Herstellung einer Injektions-/Infusionslösung

Field of application

Zytostatikum

ATC

L01BB05 - FLUDARABINE

07.16.1. – cytostatics

Use

HAM – Human medicine

pharmaceutical form

KOIN – Concentrate for solution for injection/infusion

Remedy code

S – synthetic products for human use

Dispensing categories

A – Dispensed once only on prescription by a physician or veterinarian (A)

Authorisation status

Z – approved

Authorisation number

66750

Initial registration date

8/15/2018

Expiry date

12/31/9999

Dosage strength

Name

Fludarabin Accord 25 mg/ml, Konzentrat zur Herstellung einer Injektions- /Infusionslösung

Field of application

Zytostatikum

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680667500018

Trade status*

No information made available

Status

A/R – Authorised / referenced

Package size

1 vial(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

50 mg fludarabini phosphas

Excipient

mannitolum
dinatrii phosphas dihydricus
16.15 mg natrium
aqua ad iniectabile

Spezialitätenliste***

Status

Date of deletion

Compulsory until

Public price (CHF)

163.70

Limitation points

None

Limitation

Yes

SB Deductible

10%

Generic

Yes

Authorisation holder

GLN**

7601001405677

Address

Accord Healthcare AG
Wuhrmattstrasse 23
4103 Bottmingen (BL)

Date of revision of the text

7/4/2024

Information for prof.

Leaflet

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Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.