Tiotropium bromide Viatris [Tiotropium bromide Mylan]

Medicinal product

(Invented) name

Active substance (s)

Tiotropis

Strength

18 µg

Pharmaceutical form

įkvepiamieji milteliai (kietosios kapsulės)

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

R03BB04, Tiotropium bromide

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2019-03-04

Date of renewal

2024-05-09

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/1710/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Tiotropis	18 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
101030	87141	1087141	lizdinė plokštelė	N30 ir NeumoHaler inhaliatorius	Receptinis	LT/1/19/4340/001	Netiekiama	-	-	No	-	-
101031	87142	1087142	lizdinė plokštelė	N60 ir NeumoHaler inhaliatorius	Receptinis	LT/1/19/4340/002	Netiekiama	-	-	No	-	-
101032	87143	1087143	lizdinė plokštelė	N90 ir NeumoHaler inhaliatorius	Receptinis	LT/1/19/4340/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-09	Perregistruotas
2019-03-04	Registruotas