Budesonide Teva

Medicinal product

(Invented) name

Budesonide Teva

Active substance (s)

Budezonidas

Strength

0,5 mg/2 ml

Pharmaceutical form

purškiamoji įkvepiamoji suspensija

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03BA02, Budesonide

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2022-07-15

Date of renewal

Documents

4985 Budesonide Teva PZ 2023 03 23.docx

4985 Pakuotės lapelis 2022 10 03.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/2714/002/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Ampulėje (2 ml) suspensijos yra:	2 ml
Budezonidas	0,5 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
108979	95085	1095085	ampulė	2 ml N5		Receptinis	LT/1/22/4985/001	Netiekiama	-	-	No	-	-
108980	95086	1095086	ampulė	2 ml N10		Receptinis	LT/1/22/4985/002	Netiekiama	-	-	No	-	-
108981	95087	1095087	ampulė	2 ml N15		Receptinis	LT/1/22/4985/003	Netiekiama	-	-	No	-	-
108982	95088	1095088	ampulė	2 ml N20		Receptinis	LT/1/22/4985/004	Netiekiama	-	-	No	-	-	Download
108983	95089	1095089	ampulė	2 ml N25		Receptinis	LT/1/22/4985/005	Netiekiama	-	-	No	-	-
108984	95090	1095090	ampulė	2 ml N30		Receptinis	LT/1/22/4985/006	Netiekiama	-	-	No	-	-
108985	95091	1095091	ampulė	2 ml N40		Receptinis	LT/1/22/4985/007	Netiekiama	-	-	No	-	-
108986	95092	1095092	ampulė	2 ml N50		Receptinis	LT/1/22/4985/008	Netiekiama	-	-	No	-	-
108987	95093	1095093	ampulė	2 ml N60		Receptinis	LT/1/22/4985/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-07-15	Registruotas