Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1792874
Name of medicinal product: DEXAMETHASON KRKA
Active substances:
Dexamethasone
Estonian, English, Latin
ATC code: H02AB02
Dosage form: tablet
Route of administration: oral use
Strengh: 20mg
Amount in package: 20TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: Rumeenia pakend
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 March 1, 2022)
Package information leaflet (PIL): EST  (last updated May 23, 2022)
Labelling:  (last updated May 23, 2022)
Last imported to Estonia: February 29, 2024
Marketing authorization holder: First Pharma OÜ 
Marketing authorization number: 989519 
Marketing authorization issued on: June 3, 2019 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Secondary marketing authorization: Yes 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05.04.2024     Yes  C00-D48    No  until 4 years   
100  05.04.2024     Yes  E89.6-E89.6; E27-E27; E89.3-E89.3; E23-E23; E25-E25  Pediaater, Endokrinoloog  Yes      
100  05.04.2024     Yes  Z94-Z94; T86-T86    No  until 4 years   
90  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Dermatoveneroloog, Pediaater, Allergoloog-immunoloog  No  from 63 years   
75  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Allergoloog-immunoloog, Pediaater, Dermatoveneroloog  No      
90  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Dermatoveneroloog, Allergoloog-immunoloog, Pediaater  No      
100  05.04.2024     Yes  E89.6-E89.6; E27-E27; E89.3-E89.3; E23-E23; E25-E25  Pediaater, Endokrinoloog  Yes  until 4 years   
100  05.04.2024     Yes  C00-D48    No      
100  05.04.2024     Yes  Z94-Z94; T86-T86    No      
100  05.04.2024     Yes      No  until 4 years   
50  05.04.2024     Yes      No      
100  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Allergoloog-immunoloog, Dermatoveneroloog, Pediaater  No  until 4 years   
90  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Dermatoveneroloog, Pediaater, Allergoloog-immunoloog  No  4 years - 17 years   
90  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Allergoloog-immunoloog, Dermatoveneroloog, Pediaater  No      
Reference price: 74,67 EUR 
Under reference price: Yes 
Reference price of daily dose: 0,28 EUR 
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: May 23, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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