RELANIUM

Medicinal product

(Invented) name

RELANIUM

Active substance (s)

Diazepamas

Strength

5 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N05BA01, Diazepam

Marketing authorisation holder

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

1994-09-07

Date of renewal

2007-11-30

Documents

0938 RELANIUM inj RPP 2025 07 01.docx

0938 Pakuotės lapelis 2025 07 01.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Diazepamas	5 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
3881	1677	1001677	ampulė	2 ml N5		Receptinis	LT/1/94/0938/001	Netiekiama	-	-	No	-	-
3882	1678	1001678	ampulė	2 ml N10		Receptinis	LT/1/94/0938/002	Netiekiama	-	-	No	-	-
3883	1676	1001676	ampulė	2 ml N50		Receptinis	LT/1/94/0938/003	Tiekiama	2025-05-23	-	No	-	-	Download

Stadijos

Data	Stadija
2007-11-30	Perregistruotas
1994-09-07	Registruotas