SAI - Detailed view

POSACONAZOL Accord Susp 40 mg/ml zum Einneh 105 ml

Drug

Name

Posaconazol Accord, Suspension zum Einnehmen

Field of application

Antimykotikum

ATC

J02AC04 - POSACONAZOLE

08.06.0. – antifungals

Use

HAM – Human medicine

pharmaceutical form

SUOR – Oral suspension

Remedy code

S – synthetic products for human use

Dispensing categories

B – Dispensed on prescription by a physician or veterinarian (B)

Authorisation status

Z – approved

Authorisation number

67366

Initial registration date

1/30/2020

Expiry date

12/31/9999

Dosage strength

Name

Posaconazol Accord 40 mg/ml, Suspension zum Einnehmen

Field of application

Antimykotikum

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680673660010

Trade status*

In trade from / since 1/30/2020

Status

A/R – Authorised / referenced

Package size

105 ml

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

200 mg posaconazolum

Excipient

25 mg macrogolglyceroli hydroxystearas
natrii citras dihydricus
acidum citricum monohydricum
dimeticonum
silica colloidalis hydrica
methylcellulosum
acidum sorbicum
polysorbatum 65
macrogoli stearas
xanthani gummi
1.75 g glucosum liquidum
glycerolum
< 12 µg acidum benzoicum
acidum sulfuricum
aromatica
10.86 mg propylenglycolum
E 171
11.4 mg E 211
aqua purificata
2.52 mg natrium