Terbital

Medicinal product

(Invented) name

Terbital

Active substance (s)

Terbinafino hidrochloridas

Strength

10 mg/g

Pharmaceutical form

kremas

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D01AE15, Terbinafine

Marketing authorisation holder

AS Grindeks, Latvija

Date of authorisation

2011-05-23

Date of renewal

2016-06-17

Documents

2472 Terbital PL 2024 10 16, VRA_19535.docx

2472 Pakuotės lapelis 2024 10 16, VRA_19535.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g kremo yra	1 g
Terbinafino hidrochloridas	10 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
33630	35991	1035991	tūbelė	15 g N1		Nereceptinis	LT/1/11/2472/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2016-06-17	Perregistruotas
2011-05-23	Registruotas