Budenofalk Uno

Medicinal product

(Invented) name

Budenofalk Uno

Active substance (s)

Budezonidas

Strength

9 mg

Pharmaceutical form

skrandyje neirios granulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A07EA06, Budesonide

Marketing authorisation holder

Dr.Falk Pharma GmbH, Vokietija

Date of authorisation

2012-10-19

Date of renewal

Documents

3103_1_5 Budenofalk Uno_PCS PL 170808.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

UK/H/2778/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename paketėlyje yra	1 vnt.
Budezonidas	9 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
36505	38837	1038837	paketėlis	N15		Receptinis	LT/1/12/3103/001	Netiekiama	-	-	No	-	-
54078	68066	1068066	paketėlis	N20		Receptinis	LT/1/12/3103/002	Netiekiama	-	-	No	-	-
54079	68067	1068067	paketėlis	N30		Receptinis	LT/1/12/3103/003	Netiekiama	-	-	No	-	-
54080	68068	1068068	paketėlis	N50		Receptinis	LT/1/12/3103/004	Netiekiama	-	-	No	-	-
54081	68069	1068069	paketėlis	N60		Receptinis	LT/1/12/3103/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-05	Išregistruotas
2012-10-19	Registruotas