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OCTOSTIM
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1022050
Name of medicinal product:
OCTOSTIM
Active substances:
Desmopressin
Estonian
,
English
,
Latin
ATC code:
H01BA02
Dosage form:
solution for injection
Route of administration:
intravenous use; subcutaneous use
Strengh:
15mcg 1ml
Amount in package:
1ml 5TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Shortening or normaliation of prolonged bleeding time in invasive therapeutic or diagnostic procedures, uremia, hepatic cirrhosis, congenital or drug-induced thrombocyte dysfunction or in patients with prolonged bleeding time of unknown origin. Prophylaxis of blood loss in minor surgical procedures in patients with haemophilia A and von Willebrand disease mild to moderate forms, if patients react positively to test-dose.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated October 30, 2018)
Package information leaflet (PIL):
EST
(last updated October 30, 2018)
Labelling:
(last updated October 22, 2018)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Ferring GmbH
Marketing authorization number:
145296
Marketing authorization issued on:
August 30, 1996
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
National
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: September 15, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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