Terbinafin-ratiopharm

Medicinal product

(Invented) name

Terbinafin-ratiopharm

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

ratiopharm GmbH, Vokietija

Date of authorisation

2008-04-07

Date of renewal

2011-06-01

Documents

1079 Pakuotės lapelis 2024 07 02.docx

1079 Terbinafin_ratiopharm II PL 2024 07 02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/0748/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo 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
23871	26552	1026552	tūbelė	7,5 g N1		Nereceptinis	LT/1/08/1079/001	Netiekiama	-	-	No	-	-
24415	27075	1027075	tūbelė	15 g N1		Nereceptinis	LT/1/08/1079/002	Tiekiama	-	-	No	-	-	Download
24416	27076	1027076	tūbelė	30 g N1		Nereceptinis	LT/1/08/1079/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-06-01	Perregistruotas
2008-04-07	Registruotas