Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1681668
Name of medicinal product: PREPARATION H
Active substances:
Yeast extract+Shark-liver oil
Estonian, English, Latin
ATC code: C05AX83
Dosage form: suppository
Route of administration: rectal use
Strengh: 23mg+69mg
Amount in package: 48TK
Legal status for supply*: Not subject to medicinal prescription
Class of active substance:  
Additional information: Tšehhi pakend
Indication: Symptomatic treatment of haemorrhoids.
Summary of product characteristics (SPC):  (last updated December 7, 2020)
Package information leaflet (PIL): EST  (last updated December 7, 2020)
Translation of package information leaflet into Russian: RUS  (last updated December 7, 2020)
Translation of package information leaflet into English: ENG  (last updated December 7, 2020)
Labelling:  (last updated December 7, 2020)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: First Pharma OÜ 
Marketing authorization number: 872215 
Marketing authorization issued on: June 8, 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Secondary marketing authorization: Yes 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ämmaemandal on õigus välja kirjutada Välja arvatud glükokortikosteroidi sisaldavad ravimid
Entry/Changing date: December 4, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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