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Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1862669
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: Rumeenia pakend
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 December 28, 2021)
Package information leaflet (PIL): EST  (last updated December 28, 2021)
Labelling:  (last updated December 28, 2021)
Last imported to Estonia: March 6, 2024
Marketing authorization holder: Lex Ano UAB 
Marketing authorization number: 1048421 
Marketing authorization issued on: December 28, 2021 
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  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Pediaater, Dermatoveneroloog, Allergoloog-immunoloog  No  until 4 years   
50  05.04.2024     Yes      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   
75  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  T86-T86; C00-D48; Z94-Z94    No  until 4 years   
90  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Dermatoveneroloog, Allergoloog-immunoloog, Pediaater  No      
90  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Dermatoveneroloog, Allergoloog-immunoloog, Pediaater  No      
90  05.04.2024     Yes  L12-L12; L23-L23; L13.0-L13.0; L10-L10; L20-L20  Pediaater, Allergoloog-immunoloog, Dermatoveneroloog  No  from 63 years   
100  05.04.2024     Yes  T86-T86; C00-D48; Z94-Z94    No      
100  05.04.2024     Yes  E89.6-E89.6; E27-E27; E89.3-E89.3; E23-E23; E25-E25  Endokrinoloog, Pediaater  Yes      
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   
100  05.04.2024     Yes      No  until 4 years   
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: July 5, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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