|
Product class:
|
Medicinal product with marketing authorization
|
|
Medicinal product class:
|
Human medicine
|
|
Name of medicinal product:
|
ACICLOVIR ACCORD
|
|
Active substances:
|
|
|
ATC code:
|
J05AB01
|
|
Dosage form:
|
concentrate for solution for infusion
|
|
Strength:
|
25mg 1ml
|
|
Legal status for supply*:
|
Subject to medicinal prescription
|
|
Summary of product characteristics (SPC):
|
 (last updated June 6, 2022)
|
|
Package information leaflet (PIL):
|
EST (last updated June 6, 2022)
|
|
Labelling:
|
(last updated May 19, 2020)
|
|
Indication:
|
is indicated for:
• the treatment and prophylaxis of herpes simplex infections
- in patients undergoing bone marrow transplantations
- during remission-induction therapy of patients with acute leukemia
• the treatment of
- primary and recurring varicella zoster infections in immunocompromised patients
- severe shingles (recurring varicella zoster infections) in patients with a normal immune response.
- Severe initial genital herpes
- Herpes simplex encephalitis
- Herpes neonatorum
|
|
Safety features:
|
Yes
|
|
Marketing authorization holder:
|
Accord Healthcare B.V.
|
|
Marketing authorization number:
|
1005720
|
|
Marketing authorization issued on:
|
May 19, 2020
|
|
Marketing authorization expires on:
|
May 19, 2025
|
|
Marketing authorization procedure type:
|
Decentralised
|
|
Assessment report:
|
|
|
Description
|
Additional condition
|
|
Hambaarstil on õigus välja kirjutada
|
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
|
1782198
|
ACICLOVIR ACCORD
|
concentrate for solution for infusion
|
25mg 1ml 10ml 1TK
|
Prescription
|
|
|
|
|
|
|
1782200
|
ACICLOVIR ACCORD
|
concentrate for solution for infusion
|
25mg 1ml 10ml 5TK
|
Prescription
|
|
|
|
|
|
|
1782211
|
ACICLOVIR ACCORD
|
concentrate for solution for infusion
|
25mg 1ml 10ml 10TK
|
Prescription
|
|
|
|
|
|
|
1782233
|
ACICLOVIR ACCORD
|
concentrate for solution for infusion
|
25mg 1ml 20ml 1TK
|
Prescription
|
|
|
|
|
|
|
1782244
|
ACICLOVIR ACCORD
|
concentrate for solution for infusion
|
25mg 1ml 20ml 5TK
|
Prescription
|
|
|
|
|
|
|
1782255
|
ACICLOVIR ACCORD
|
concentrate for solution for infusion
|
25mg 1ml 20ml 10TK
|
Prescription
|
|
|
|
|
|
|
1782266
|
ACICLOVIR ACCORD
|
concentrate for solution for infusion
|
25mg 1ml 40ml 1TK
|
Prescription
|
|
|
|
|
|
|
1782277
|
ACICLOVIR ACCORD
|
concentrate for solution for infusion
|
25mg 1ml 40ml 5TK
|
Prescription
|
|
|
|
|
|
|
1782288
|
ACICLOVIR ACCORD
|
concentrate for solution for infusion
|
25mg 1ml 40ml 10TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere