Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1087871
Name of medicinal product: AMLOCARD 5 MG
Active substances:
Amlodipine
Estonian, English, Latin
ATC code: C08CA01
Dosage form: tablet
Route of administration: oral use
Strengh: 5mg
Amount in package: 30TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Hypertension Chronic stable angina pectoris Vasospastic (Prinzmetal's) angina
Safety features: Yes
Summary of product characteristics (SPC):  (last updated October 24, 2022)
Package information leaflet (PIL): EST  (last updated October 24, 2022)
Translation of package information leaflet into Russian: RUS  (last updated November 2, 2020)
Translation of package information leaflet into English: ENG  (last updated November 2, 2020)
Labelling:  (last updated October 24, 2022)
Last imported to Estonia: June 14, 2017
Marketing authorization holder: Hexal AG 
Marketing authorization number: 538507 
Marketing authorization issued on: February 12, 2007 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
90  05.04.2024     Yes  I15-I15; I10-I13; I20-I20    No  from 63 years   
90  05.04.2024     Yes  I15-I15; I10-I13; I20-I20    No      
90  05.04.2024     Yes  I15-I15; I10-I13; I20-I20    No      
100  05.04.2024     Yes  I15-I15; I10-I13; I20-I20    No  until 4 years   
100  05.04.2024     Yes      No  until 4 years   
75  05.04.2024     Yes  I15-I15; I10-I13; I20-I20    No      
50  05.04.2024     Yes      No      
90  05.04.2024     Yes  I15-I15; I10-I13; I20-I20    No  4 years - 17 years   
Reference price: 1,20 EUR 
Under reference price: No 
Reference price of daily dose: 0,04 EUR 
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Entry/Changing date: April 23, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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