SAI - Detailed view

LINEZOLID Pfizer Gran 20 mg/ml f Susp Fl 150 ml

Drug

Name

Linezolid Pfizer, Granulat zur Herstellung einer Suspension zum Einnehmen

Field of application

Infektionskrankheiten

ATC

J01XX08 - LINEZOLID

08.01.9. – other antibaterial pathogen agents

Use

HAM – Human medicine

pharmaceutical form

GRAS – Granules for oral suspension

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 category

C – NA Co-Marketing

Authorisation number

66250

Basic authorisation number

55559

Initial registration date

6/9/2016

Expiry date

12/31/9999

Dosage strength

Name

Linezolid Pfizer 20 mg/ml, Granulat zur Herstellung einer Suspension zum Einnehmen

Field of application

Infektionskrankheiten

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680662500013

Trade status*

In trade from / since 6/9/2016

Status

A/R – Authorised / referenced

Package size

150 ml

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

20 mg linezolidum

Excipient

210.58 mg saccharum
acidum citricum
natrii citras anhydricus
cellulosum microcristallinum
carmellosum natricum
7 mg aspartamum
xanthani gummi
mannitolum
2 mg E 211
aromatica
0.2 mg ethanolum
maltodextrinum
silica colloidalis anhydrica
aromatica
aromatica
propylenglycolum
alcohol benzylicus
maltodextrinum
natrii chloridum
8.76 mg sorbitolum
3.36 mg fructosum
maltodextrinum
acidum glycyrrhizinicum
ammonii glycyrrhizas
triglycerida media
aromatica
ethanolum
amylum modificatum
maltodextrinum
2.279 mg natrium