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GAMMANORM
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1638356
Name of medicinal product:
GAMMANORM
Active substances:
Immunoglobulins, normal human, for extravascular a
Estonian
,
English
,
Latin
ATC code:
J06BA01
Dosage form:
solution for injection
Route of administration:
subcutaneous use; intramuscular use
Strengh:
165mg 1ml
Amount in package:
6ml 20TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
Indications for subcutaneous administration (SCIg) Replacement therapy in adults, children and adolescents (0-18 years) in: Primary immunodeficiency syndromes such with impaired antibody production (see section 4.4) Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated. Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients Hypogammaglobulinaemia in patients pre- and post- allogenic haematopoietic stem cell transplantation (HSCT)
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated June 8, 2022)
Package information leaflet (PIL):
EST
(last updated June 8, 2022)
Labelling:
(last updated June 8, 2022)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Octapharma (Ip)
Marketing authorization number:
501705
Marketing authorization issued on:
November 11, 2005
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Mutual recognition
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: June 8, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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