TOBI Podhaler

Medicinal product

(Invented) name

TOBI Podhaler

Active substance (s)

Tobramicinas

Strength

28 mg

Pharmaceutical form

įkvepiamieji milteliai (kietosios kapsulės)

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01GB01, Tobramycin

Marketing authorisation holder

Viatris Healthcare Limited, Airija

Date of authorisation

2011-07-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Inhalation powder, hard capsule	1 vnt.
Tobramicinas	28 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
48139	61964	1061964	lizdinė plokštelė	N56+1 inhaliatorius		Receptinis	EU/1/10/652/001	Netiekiama	-	-	No	-	-
48140	61965	1061965	lizdinė plokštelė	N224 (4 x 56) ir 5 inhaliatoriai (mėn. pakuotė)		Receptinis	EU/1/10/652/002	Netiekiama	2025-01-01	2026-01-02	Yes	2025-07-01	2025-12-31
48141	61966	1061966	lizdinė plokštelė	N448 (8 x 56) ir 10 inhaliatorių (2 mėn. pak., įpakuotos i foliją)		Receptinis	EU/1/10/652/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-07-20	Registruotas