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PALFORZIA
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1836996
Name of medicinal product:
PALFORZIA
Active substances:
peanut protein
Estonian
,
English
,
Latin
ATC code:
V01AA86
Dosage form:
oral powder in single-dose container
Route of administration:
oral use
Strengh:
1mg/10mg
Amount in package:
32TK / 16TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
PALFORZIA is indicated for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. PALFORZIA may be continued in patients 18 years of age and older. PALFORZIA should be used in conjunction with a peanut-avoidant diet.
Safety features:
No
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:
Aimmune Therapeutics Ireland Limited
Marketing authorization number:
EU/1/20/1495
Marketing authorization issued on:
December 17, 2020
Marketing authorization expires on:
December 21, 2025
Marketing authorization procedure type:
Centralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: January 6, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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