|
Product class:
|
Authorized package
|
|
Medicinal product class:
|
For human use
|
|
Package code:
|
1836413
|
|
Name of medicinal product:
|
ACIC 400 MG
|
|
Active substances:
|
|
|
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:
|
Saksamaa pakend
|
|
Indication:
|
Herpes simplex and Varicella zoster viral infection.
|
|
Safety features:
|
Yes
|
|
Summary of product characteristics (SPC):
|
 (last updated May 5, 2021)
|
|
Package information leaflet (PIL):
|
EST (last updated May 5, 2021)
|
|
Labelling:
|
(last updated May 5, 2021)
|
|
Last imported to Estonia:
|
April 18, 2023
|
|
Marketing authorization holder:
|
Lex Ano UAB
|
|
Marketing authorization number:
|
1028821
|
|
Marketing authorization issued on:
|
May 5, 2021
|
|
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
|
01.04.2023
|
|
Yes
|
|
|
No
|
|
|
|
100
|
01.04.2023
|
|
Yes
|
Z94-Z94; T86-T86
|
|
No
|
|
|
|
100
|
01.04.2023
|
|
Yes
|
D60-D64
|
Hematoloog, Pediaater
|
No
|
until 4 years
|
|
|
100
|
01.04.2023
|
|
Yes
|
D60-D64
|
Pediaater, Hematoloog
|
No
|
|
|
|
100
|
01.04.2023
|
|
Yes
|
|
|
No
|
until 4 years
|
|
|
100
|
01.04.2023
|
|
Yes
|
Z94-Z94; T86-T86
|
|
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:
May 5, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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