Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1889376
Name of medicinal product: DEXAMETHASON KRKA
Active substances:
Dexamethasone
Estonian, English, Latin
ATC code: H02AB02
Dosage form: tablet
Route of administration: oral use
Strengh: 4mg
Amount in package: 20TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Neurology Cerebral oedema (only with symptoms of intracranial pressure evidenced by computerised tomography) caused by a brain tumour, neuro-surgical intervention, cerebral abscess. Pulmonary and respiratory diseases Acute asthma exacerbations when use of an oral corticosteroid (OCS) is appropriate, croup. Dermatology Initial treatment of extensive, severe, acute, skin diseases responding to glucocorticoids, e.g. erythroderma, pemphigus vulgaris. Autoimmune disorders/rheumatology Initial treatment of autoimmune disorders like systemic lupus erythematodes. Active phases of systemic vasculitides like panarteritis nodosa (treatment duration should be limited to two weeks in cases of concomitant positive hepatitis B serology). Severe progressive course of active rheumatoid arthritis, e.g. fast proceeding destructive forms and/or extraarticular manifestations. Severe systemic course of juvenile idiopathic arthritis (Still’s disease). Haematological disorder Idiopathic thrombocytopenic purpura in adults. Infectology Tuberculous meningitis only in conjunction with anti-infective therapy. 4 mg tablets is indicated in the treatment of coronavirus disease 2019 (COVID-19) in adult and adolescent patients (aged 12 years and older with body weight at least 40 kg) who require supplemental oxygen therapy. Oncology Palliative treatment of neoplastic diseases. 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. Various Prevention and treatment of postoperative vomiting, within antiemetic treatment.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated November 30, 2022)
Package information leaflet (PIL): EST  (last updated January 8, 2024)
Labelling:  (last updated January 8, 2024)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Ideal Trade Links UAB 
Marketing authorization number: 1088022 
Marketing authorization issued on: November 30, 2022 
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
90  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Dermatoveneroloog, Allergoloog-immunoloog, Pediaater  No  4 years - 17 years   
100  05.04.2024     Yes  C00-D48    No  until 4 years   
90  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Allergoloog-immunoloog, Dermatoveneroloog, Pediaater  No      
50  05.04.2024     Yes      No      
90  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Allergoloog-immunoloog, Dermatoveneroloog, Pediaater  No      
100  05.04.2024     Yes  E89.6-E89.6; E27-E27; E89.3-E89.3; E23-E23; E25-E25  Endokrinoloog, Pediaater  Yes  until 4 years   
100  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Allergoloog-immunoloog, Pediaater, Dermatoveneroloog  No  until 4 years   
100  05.04.2024     Yes  Z94-Z94; T86-T86    No      
100  05.04.2024     Yes  Z94-Z94; T86-T86    No  until 4 years   
75  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Dermatoveneroloog, Pediaater, Allergoloog-immunoloog  No      
100  05.04.2024     Yes      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   
100  05.04.2024     Yes  C00-D48    No      
100  05.04.2024     Yes  E89.6-E89.6; E27-E27; E89.3-E89.3; E23-E23; E25-E25  Endokrinoloog, Pediaater  Yes      
Reference price: 14,93 EUR 
Under reference price: Yes 
Reference price of daily dose: 0,28 EUR 
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: January 8, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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