Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Veterinary medicine
Name of medicinal product: Dophexine
Active substances:
Bromhexine
Estonian, English, Latin
ATC code: QR05CB02
Dosage form: powder for use in drinking water/milk
Strength: 18,2mg 1g
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated September 1, 2020)
Package information leaflet (PIL): EST  (last updated September 1, 2020)
Labelling:  (last updated September 1, 2020)
Indication: Mucolytic treatment of congested respiratory tract.
Safety features: No
Marketing authorization holder: Dopharma Research B.V. 
Marketing authorization number: 2246 
Marketing authorization issued on: August 31, 2020 
Marketing authorization expires on: August 31, 2025 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1796430  Dophexine  powder for use in drinking water/milk  18,2mg 1g 1000g 1TK  Prescription      20.05.2024     
1796441  Dophexine  powder for use in drinking water/milk  18,2mg 1g 2500g 1TK  Prescription           
1796452  Dophexine  powder for use in drinking water/milk  18,2mg 1g 5000g 1TK  Prescription      18.04.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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