GEPSAM

Medicinal product

(Invented) name

GEPSAM

Active substance (s)

Ademetioninas

Strength

500 mg/5 ml

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AA02, Ademetionine

Marketing authorisation holder

UAB Vigifarma, Lietuva

Date of authorisation

2015-04-13

Date of renewal

2021-03-12

Documents

3704 Gepsam 500_perreg2021-03-12.docx

3704 pakuotes lapelis_2021-03-12.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Viename flakone yra	5 ml
Ademetioninas	500 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
58499	72665	1072665	flakonas	milteliai iir tirpiklio ampulė (5 ml) N5		Receptinis	LT/1/15/3704/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-03-12	Perregistruotas
2015-04-13	Registruotas