Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1738289
Name of medicinal product: ACIC 400 MG
Active substances:
Aciclovir
Estonian, English, Latin
ATC code: J05AB01
Dosage form: tablet
Route of administration: oral use
Strengh: 400mg
Amount in package: 35TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Herpes simplex and Varicella zoster viral infection.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated July 29, 2019)
Package information leaflet (PIL): EST  (last updated July 29, 2019)
Labelling:  (last updated July 23, 2019)
Last imported to Estonia: June 21, 2018
Marketing authorization holder: Globalex Pharma OÜ 
Marketing authorization number: 936817 
Marketing authorization issued on: May 9, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Secondary marketing authorization: Yes 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  01.10.2022     Yes      No      
100  01.10.2022     Yes  D60-D64  Pediaater, Hematoloog  No  until 4 years   
100  01.10.2022     Yes  D60-D64  Pediaater, Hematoloog  No      
100  01.10.2022     Yes  Z94-Z94; T86-T86    No      
100  01.10.2022     Yes  Z94-Z94; T86-T86    No  until 4 years   
100  01.10.2022     Yes      No  until 4 years   
Reference price: 21,18 EUR 
Under reference price: Yes 
Reference price of daily dose: 6,05 EUR 
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: July 8, 2019
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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