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ADYNOVI
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1762488
Name of medicinal product:
ADYNOVI
Active substances:
Human coagulation factor VIII
Estonian
,
English
,
Latin
ATC code:
B02BD02
Dosage form:
powder and solvent for solution for injection
Route of administration:
intravenous use
Strengh:
1000RÜ
Amount in package:
1TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
lahusti 5 ml
Indication:
Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).
Safety features:
Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL):
EST
Labelling:
Last imported to Estonia:
Never imported to Estonia
:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions
to State Agency of Medicines
.
State Agency of Medicines
Marketing authorization
Marketing authorization holder:
Baxalta Innovations GmbH
Marketing authorization number:
EU/1/17/1247
Marketing authorization issued on:
January 8, 2018
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Centralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Perscription conditions and restrictions
Description
Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: December 19, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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