Piracetam Kalceks

Medicinal product

(Invented) name

Piracetam Kalceks

Active substance (s)

Piracetamas

Strength

200 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N06BX03, Piracetam

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2016-03-10

Date of renewal

2020-11-20

Documents

3887 Pakuotės lapelis 2024 10 01.docx

Piracetam_BB_AR.pdf

3887 Piracetam Kalceks PL 2024 10 01, VRA rastas 17041.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Piracetamas	200 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
61719	76062	1076062	ampulė	5 ml N10		Receptinis	LT/1/16/3887/001	Tiekiama	-	-	No	-	-	Download
65227	79728	1079728	ampulė	5 ml N100		Receptinis	LT/1/16/3887/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-11-20	Perregistruotas
2016-03-10	Registruotas