Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: PALFORZIA
Active substances:
peanut protein
Estonian, English, Latin
ATC code: V01AA86
Dosage form: oral powder in single-dose container
Strength: 1mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
: 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: December 17, 2020 
Marketing authorization expires on: December 21, 2025 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1836907  PALFORZIA  oral powder in single-dose container  1mg 48TK  Prescription           
1836918  PALFORZIA  oral powder in single-dose container  1mg 96TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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