MILDRONATE

Medicinal product

(Invented) name

MILDRONATE

Active substance (s)

Meldonio dihidratas

Strength

100 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01EB22, Meldonium

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

1997-06-06

Date of renewal

2011-06-15

Documents

2519 MILDRONATE inj PL 2024 11 04, VRA.docx

2519 Pakuotės lapelis inj 2024 11 04, VRA.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo	1 ml
Meldonio dihidratas	100 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
11534	15988	1015988	ampulė	5 ml N10		Receptinis	LT/1/97/2519/003	Tiekiama	-	-	No	-	-	Download
64846	79336	1079336	ampulė	5 ml N20		Receptinis	LT/1/97/2519/004	Tiekiama	-	-	No	-	-
113872	99989	1099989	ampulė	10 ml N5		Receptinis	LT/1/97/2519/006	Tiekiama	2025-01-16	-	No	-	-
113873	99990	1099990	ampulė	10 ml N10		Receptinis	LT/1/97/2519/007	Tiekiama	2025-01-16	-	No	-	-

Stadijos

Data	Stadija
2011-06-15	Perregistruotas
1997-06-06	Registruotas