Terbinafine Actavis

Medicinal product

(Invented) name

Terbinafine Actavis

Active substance (s)

Terbinafinas

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

Actavis Group PTC ehf., Islandija

Date of authorisation

2009-11-25

Date of renewal

2013-04-16

Documents

1793_1_3 Terbinafine Actavis_kremas PZ PL 180411.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

MT/H/0258/001

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 g kremo yra	1 g
Terbinafinas	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
35216	37552	1037552	tūbelė	7,5 g N1		Nereceptinis	LT/1/09/1793/001	Netiekiama	-	-	No	-	-
38334	51990	1051990	tūbelė	15 g N1		Nereceptinis	LT/1/09/1793/002	Netiekiama	-	-	No	-	-
38335	51991	1051991	tūbelė	30 g N1		Nereceptinis	LT/1/09/1793/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-05-08	Išregistruotas
2013-04-16	Perregistruotas
2009-11-25	Registruotas