Product class: Authorized package
Medicinal product class: For human use
Package code: 1836918
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
Amount in package: 96TK
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 holder: Aimmune Therapeutics Ireland Limited 
Marketing authorization number: EU/1/20/1495 
Marketing authorization issued on: 17 December 2020 
Marketing authorization expires on: 21 December 2025 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 06 January 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription