SAI - Detailed view

PROSTIN VR Inf Konz 500 mcg/ml 5 Amp 1 ml

Drug

Name

Prostin VR, Konzentrat zur Herstellung einer Infusionslösung

Field of application

Zur temporären Oeffnung des Ductus arteriosus bei Neugeborenen mit angeborenen Herzfehlern

ATC

C01EA01 - ALPROSTADIL

02.99.0. – various

Use

HAM – Human medicine

pharmaceutical form

KOINF – Concentrate for solution for 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

45333

Initial registration date

12/27/1983

Expiry date

12/31/9999

Dosage strength

Name

Prostin VR, Konzentrat zur Herstellung einer Infusionslösung

Field of application

Zur temporären Oeffnung des Ductus arteriosus bei Neugeborenen mit angeborenen Herzfehlern

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680453330195

Trade status*

No information made available

Status

A/R – Authorised / referenced

Package size

5 ampoule(s)

Package code

019

Authorisation status

Z – approved

Declaration

Component

Active substance

0.5 mg alprostadilum

Excipient

789 mg ethanolum

Authorisation holder

GLN**

7601001010604

Address

Pfizer AG
Schärenmoosstrasse 99
8052 Zürich (ZH)

Date of revision of the text

8/1/2022

Information for prof.

Leaflet

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