Bedikertal

Medicinal product

(Invented) name

Bedikertal

Active substance (s)

Betametazonas/Salicilo rūgštis

Strength

0,5 mg/30 mg/g

Pharmaceutical form

tepalas

Route (s) of administration

vartoti ant odos

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D07XC01, Betamethasone

Marketing authorisation holder

Przedsiebiorstwo Pharmaceutyczne Jelfa S.A., Lenkija

Date of authorisation

2012-04-06

Date of renewal

2017-10-25

Documents

2887_1-2 Bedicertal_perr1025.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

PL/H/0362/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g tepalo yra	1 g
Betametazonas	0,5 mg
Salicilo rūgštis	30 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
44510	58305	1058305	tūbelė	15 g N1		Receptinis	LT/1/12/2887/001	Netiekiama	-	-	No	-	-
44511	58306	1058306	tūbelė	30 g N1		Receptinis	LT/1/12/2887/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-02-07	Išregistruotas
2017-10-25	Perregistruotas
2012-04-06	Registruotas