PK-Merz

Medicinal product

(Invented) name

PK-Merz

Active substance (s)

Amantadino sulfatas

Strength

0,4 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N04BB01, Amantadine

Marketing authorisation holder

Merz Pharmaceuticals GmbH, Vokietija

Date of authorisation

1994-07-05

Date of renewal

2013-12-31

Documents

0617 Pakuotės lapelis inf 2025 04 09.docx

0617 PK_Merz inf tirp RPP 2025 04 09.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Amantadino sulfatas	0,4 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
24233	26897	1026897	buteliukas	500 ml N1		Receptinis	LT/1/94/0617/003	Tiekiama	-	-	No	-	-
24234	26898	1026898	buteliukas	500 ml N10		Receptinis	LT/1/94/0617/004	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2013-12-31	Perregistruotas
1994-07-05	Registruotas