Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1552845
|
Name of medicinal product:
|
ADVATE
|
Active substances:
|
|
ATC code:
|
B02BD02
|
Dosage form:
|
powder and solvent for solution for injection
|
Route of administration:
|
intravenous use
|
Strengh:
|
500RÜ
|
Amount in package:
|
1TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
lahusti 2 ml
|
Indication:
|
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII
deficiency). ADVATE is indicated in all age groups.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Last imported to Estonia:
|
December 6, 2016
|
Marketing authorization holder:
|
Takeda Manufacturing Austria AG
|
Marketing authorization number:
|
EU/1/03/271
|
Marketing authorization issued on:
|
December 19, 2011
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
D66-D66
|
Hematoloog, Pediaater, Pediaater – hematoloog-onkoloog
|
No
|
|
|
100
|
01.01.2024
|
01.04.2024
|
Yes
|
D66-D66
|
Pediaater – hematoloog-onkoloog, Pediaater, Hematoloog
|
No
|
until 4 years
|
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Description
|
Additional condition
|
Hambaarstil on õigus välja kirjutada
|
|
Entry/Changing date:
April 17, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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