Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
ICATIBANT AUXILIA
|
Active substances:
|
|
ATC code:
|
B06AC02
|
Dosage form:
|
solution for injection in pre-filled syringe
|
Strength:
|
30mg 3ml
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
(last updated May 9, 2022)
|
Package information leaflet (PIL):
|
EST (last updated May 9, 2022)
|
Labelling:
|
(last updated May 9, 2022)
|
Indication:
|
|
Safety features:
|
Yes
|
Marketing authorization holder:
|
Auxilia Pharma OÜ
|
Marketing authorization number:
|
1062122
|
Marketing authorization issued on:
|
May 9, 2022
|
Marketing authorization expires on:
|
May 9, 2027
|
Marketing authorization procedure type:
|
National
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1823330
|
ICATIBANT AUXILIA
|
solution for injection in pre-filled syringe
|
30mg 3ml 3ml 1TK
|
Prescription
|
|
|
|
|
|
1823341
|
ICATIBANT AUXILIA
|
solution for injection in pre-filled syringe
|
30mg 3ml 3ml 3TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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