Spiolto Respimat

Medicinal product

(Invented) name

Spiolto Respimat

Active substance (s)

Tiotropis/Olodaterolis

Strength

2,5 µg/2,5 µg/išpurškime

Pharmaceutical form

įkvepiamasis tirpalas

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03AL06, Olodaterol and tiotropium bromide

Marketing authorisation holder

UAB Niromed, Lietuva

Date of authorisation

2026-09-24

Date of renewal

Documents

3614_Spiolto Respimat įkv_tirp_PL_2026-09-24.docx

3614_Spiolto Respimat įkv_tirp_PZ_2026-09-24.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Viename išpurškime (išpurškiamoje dozėje) yra	1 išpurškime
Tiotropis	2,5 µg
Olodaterolis	2,5 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
122367	108479	1108479	užtaisas	60 išpurškimų N1 ir kartotinio naudojimo inhaliatorius		Receptinis	LT/L/26/3614/001	Netiekiama	-	-	No	-	-	Download
122368	108480	1108480	užtaisas	60 išpurškimų N3 ir kartotinio naudojimo inhaliatorius		Receptinis	LT/L/26/3614/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-09-24	Registruotas