Malarone

Medicinal product

(Invented) name

Malarone

Active substance (s)

Atovakvonas/Proguanilo hidrochloridas

Strength

250 mg/100 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

P01BB51, proguanil and atovaquone

Marketing authorisation holder

UAB Niromed, Lietuva

Date of authorisation

2024-12-02

Date of renewal

Documents

2264_Malarone 250-100mg_pl_d_tab_PZ_2024-12-02.docx

2264_Malarone 250-100mg_pl_d_tab_PL_2024-12-02.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Atovakvonas	250 mg
Proguanilo hidrochloridas	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
115894	101999	1101999	lizdinė plokštelė	N12		Receptinis	LT/L/24/2264/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-12-02	Registruotas