Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: AGEN 5MG
Active substances:
Amlodipine
Estonian, English, Latin
ATC code: C08CA01
Dosage form: tablet
Strength: 5mg
Legal status for supply*: Subject to medicinal prescription
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)
Indication:
Safety features: Yes
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 
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
1109876  AGEN 5MG  tablet  5mg 10TK  Prescription           
1109887  AGEN 5MG  tablet  5mg 30TK  Prescription  90% 100% 50% 75%  1,20  31.05.2024     
1207066  AGEN 5MG  tablet  5mg 90TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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