Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1109876
Name of medicinal product: AGEN 5MG
Active substances:
Amlodipine
Estonian, English, Latin
ATC code: C08CA01
Dosage form: tablet
Route of administration: oral use
Strengh: 5mg
Amount in package: 10TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication:
Safety features: Yes
Summary of product characteristics (SPC):  (last updated August 24, 2022)
Package information leaflet (PIL): EST  (last updated August 24, 2022)
Translation of package information leaflet into Russian: RUS  (last updated August 24, 2022)
Translation of package information leaflet into English: ENG  (last updated August 24, 2022)
Labelling:  (last updated January 8, 2018)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Zentiva k.s. 
Marketing authorization number: 418303 
Marketing authorization issued on: August 8, 2003 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Entry/Changing date: October 11, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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