Serkep

Medicinal product

(Invented) name

Serkep

Active substance (s)

Salmeterolis/Flutikazono propionatas

Strength

25 µg/125 µg/dozėje

Pharmaceutical form

suslėgtoji įkvepiamoji suspensija

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AK06, Salmeterol and fluticasone

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2016-12-08

Date of renewal

2021-02-10

Documents

4018 Serkep PZ PL 2025 01 01.docx

4018 Pakuotės lapelis 2025 01 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/5724/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Dozėje (išpurškiamoje per vožtuvą) yra:	1 dozėje
Salmeterolis	25 µg
Flutikazono propionatas	125 µg

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
67267	81813	1081813	inhaliatorius	120 dozių N1		Receptinis	LT/1/16/4018/001	Netiekiama	2025-01-30	2025-05-15	No	-	-	Download

Stadijos

Data	Stadija
2021-02-10	Perregistruotas
2016-12-08	Registruotas