NALOXONUM WZF Polfa

Medicinal product

(Invented) name

NALOXONUM WZF Polfa

Active substance (s)

Naloksono hidrochloridas

Strength

400 µg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis, leisti į odą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V03AB15, Naloxone

Marketing authorisation holder

Warszawskie Zakłady Farmaceutyczne Polfa S.A., Lenkija

Date of authorisation

1995-04-05

Date of renewal

2010-03-19

Documents

1928_1_Pakuotes lapelis_200529.docx

1928_1_NALOXONUM WZF Polfa_inj_inf_tirp_RPP_200529.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Ampulėje (1 ml) yra	1 ml
Naloksono hidrochloridas	400 µg

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
1145	6971	1006971	ampulė	1 ml N10		Receptinis	LT/1/95/1928/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2025-06-02	Išregistruotas
2010-03-19	Perregistruotas
1995-04-05	Registruotas