Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: KETOCONAZOL-RATIOPHARM 20 MG/ML
Active substances:
Ketoconazole
Estonian, English, Latin
ATC code: D01AC08
Dosage form: shampoo
Strength: 20mg 1ml
Legal status for supply*: Not subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated August 19, 2022)
Package information leaflet (PIL): EST  (last updated August 19, 2022)
Translation of package information leaflet into Russian: RUS  (last updated October 30, 2020)
Translation of package information leaflet into English: ENG  (last updated October 30, 2020)
Labelling:  (last updated August 19, 2022)
Indication: Seborrheic dermatitis of the scalp and pityriasis capitis (dandruff).
Marketing authorization holder: Ratiopharm GmbH 
Marketing authorization number: 537407 
Marketing authorization issued on: February 12, 2007 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported Additional information
1255395  KETOCONAZOL-RATIOPHARM 20 MG/ML  shampoo  20mg 1ml 60ml 1TK  OTC      02.12.2021   
1255407  KETOCONAZOL-RATIOPHARM 20 MG/ML  shampoo  20mg 1ml 100ml 1TK  OTC      11.02.2009   
1287514  KETOCONAZOL-RATIOPHARM 20 MG/ML  shampoo  20mg 1ml 120ml 1TK  OTC      31.03.2020   
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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