MILDRONATE

Medicinal product

(Invented) name

MILDRONATE

Active substance (s)

Meldonio dihidratas

Strength

500 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01EB22, Meldonium

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

2004-02-10

Date of renewal

2011-06-15

Documents

2519 Pakuotės lapelis kaps 2024 10 16, VRA_19535.docx

2519 MILDRONATE kaps PL 2024 10 16, VRA_19535.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Meldonio dihidratas	500 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
11538	15992	1015992	lizdinė plokštelė	N60		Receptinis	LT/1/97/2519/002	Tiekiama	-	-	No	-	-	Download
105413	91513	1091513	lizdinė plokštelė	N90		Receptinis	LT/1/97/2519/005	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-06-15	Perregistruotas
2004-02-10	Registruotas