Hedelix s.a.

Medicinal product

(Invented) name

Hedelix s.a.

Active substance (s)

Gebenių (Hederae folium) lapų tirštasis ekstraktas (2,2-2,9:1)

Strength

40 mg/ml

Pharmaceutical form

geriamieji lašai (tirpalas)

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R05CA12, Hederae helicis folium

Marketing authorisation holder

Krewel Meuselbach GmbH, Vokietija

Date of authorisation

1998-10-22

Date of renewal

2010-11-10

Documents

0052 Hedelix s_a geriam lasai PL 2025 05 05.docx

0052 Pakuotės lapelis geriam lasai 2025 05 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo (31 laše) yra	1 ml
Gebenių (Hederae folium) lapų tirštasis ekstraktas (2,2-2,9:1)	40 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
11149	15651	1015651	buteliukas	50 ml su lašintuvu N1		Nereceptinis	LT/1/94/0052/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2010-11-10	Perregistruotas
1998-10-22	Registruotas