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CUTAQUIG
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1787104
Name of medicinal product:
CUTAQUIG
Active substances:
Immunoglobulins, normal human, for extravascular a
Estonian
,
English
,
Latin
ATC code:
J06BA01
Dosage form:
solution for injection
Route of administration:
subcutaneous use
Strengh:
165mg 1ml
Amount in package:
48ml 10TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Replacement therapy in adults, children and adolescents (0-18 years) in Primary immunodeficiency (PID) syndromes with impaired antibody production (see section 4.4). Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4g/l. *PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated December 12, 2023)
Package information leaflet (PIL):
EST
(last updated December 12, 2023)
Labelling:
(last updated January 12, 2023)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Octapharma (Ip)
Marketing authorization number:
983219
Marketing authorization issued on:
April 2, 2019
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Perscription conditions and restrictions
Description
Additional condition
Ei ole lubatud väljastada korduvretsepti
Entry/Changing date: February 21, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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