Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1671858
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Name of medicinal product:
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DEXAMETHASON KRKA
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Active substances:
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|
ATC code:
|
H02AB02
|
Dosage form:
|
tablet
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Route of administration:
|
oral use
|
Strengh:
|
40mg
|
Amount in package:
|
30TK
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
|
Dermatology
Pemphigus vulgaris.
Autoimmune disorders/rheumatology
Myositis.
Haematological disorder
Idiopathic thrombocytopenic purpura in adults.
Oncology
Metastatic spinal cord compression.
Prophylaxis and treatment of emesis induced by cytostatics, emetogenic chemotherapy within antiemetic treatment.
Treatment of symptomatic multiple myeloma, acute lymphoblastic leukemia, Hodgkin's disease and non-Hodgkin's lymphoma in combination with other medicinal products.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated April 6, 2023)
|
Package information leaflet (PIL):
|
EST (last updated April 6, 2023)
|
Labelling:
|
(last updated September 10, 2021)
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Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
KRKA, d.d., Novo mesto
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Marketing authorization number:
|
915216
|
Marketing authorization issued on:
|
September 13, 2016
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Decentralised
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Description
|
Additional condition
|
Hambaarstil on õigus välja kirjutada
|
|
Entry/Changing date:
September 13, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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