DAPLOXIN

Medicinal product

(Invented) name

DAPLOXIN

Active substance (s)

Dapoksetino hidrochloridas

Strength

60 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)

G04BX14, Dapoxetine

Marketing authorisation holder

Medochemie Ltd., Kipras

Date of authorisation

2020-04-29

Date of renewal

2024-12-13

Documents

4544-5_pakuotes lapelis_2024-12-13.docx

4544-5_Daploxin_perr2024-12-13.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2260/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Dapoksetino hidrochloridas	60 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
103950	90052	1090052	lizdinė plokštelė	N2		Receptinis	LT/1/20/4545/001	Netiekiama	-	-	No	-	-
103951	90053	1090053	lizdinė plokštelė	N3		Receptinis	LT/1/20/4545/002	Netiekiama	-	-	No	-	-
103952	90054	1090054	lizdinė plokštelė	N4		Receptinis	LT/1/20/4545/003	Netiekiama	-	-	No	-	-
103953	90055	1090055	lizdinė plokštelė	N6		Receptinis	LT/1/20/4545/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-12-13	Perregistruotas
2020-04-29	Registruotas