Register of Medicinal Products

ACICLOVIR ACCORD

Product class:	Authorized package
Medicinal product class:	For human use
Package code:	1782198
Name of medicinal product:	ACICLOVIR ACCORD
Active substances:	Aciclovir Estonian, English, Latin
ATC code:	J05AB01
Dosage form:	concentrate for solution for infusion
Route of administration:	intravenous use
Strengh:	25mg 1ml
Amount in package:	10ml 1TK
Legal status for supply*:	Subject to medicinal prescription
Class of active substance:
Additional information:
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
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)
Last imported to Estonia:	Never imported to Estonia

Marketing authorization

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

Reference price:
Under reference price:
Reference price of daily dose:

Perscription conditions and restrictions

Description	Additional condition
Hambaarstil on õigus välja kirjutada

Entry/Changing date: June 6, 2022

Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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