Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: LEVOTHYROXINE ACCORD
Active substances:
Levothyroxine sodium
Estonian, English, Latin
ATC code: H03AA01
Dosage form: tablet
Strength: 50mcg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated October 17, 2023)
Package information leaflet (PIL): EST  (last updated October 17, 2023)
Labelling:  (last updated March 24, 2020)
Indication: * Treatment of benign euthyroid goitre * Prophylaxis of relapse after surgery for euthyroid goitre, depending on the post-operative hormone status * Substitution therapy in hypothyroidism * Suppression therapy in thyroid cancer * Concomitant supplementation during anti-thyroid drug treatment of hyperthyroidism
Safety features: Yes
Marketing authorization holder: Accord Healthcare B.V. 
Marketing authorization number: 1003120 
Marketing authorization issued on: March 24, 2020 
Marketing authorization expires on: March 24, 2025 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1775820  LEVOTHYROXINE ACCORD  tablet  50mcg 10TK  Prescription           
1775831  LEVOTHYROXINE ACCORD  tablet  50mcg 30TK  Prescription           
1775842  LEVOTHYROXINE ACCORD  tablet  50mcg 50TK  Prescription           
1775853  LEVOTHYROXINE ACCORD  tablet  50mcg 56TK  Prescription           
1775864  LEVOTHYROXINE ACCORD  tablet  50mcg 90TK  Prescription           
1775875  LEVOTHYROXINE ACCORD  tablet  50mcg 100TK  Prescription           
1775886  LEVOTHYROXINE ACCORD  tablet  50mcg 200TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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