Carmustine Zentiva

Medicinal product

(Invented) name

Carmustine Zentiva

Active substance (s)

Karmustinas

Strength

100 mg

Pharmaceutical form

milteliai ir tirpiklis infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01AD01, Carmustine

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2019-07-02

Date of renewal

2024-04-24

Documents

4407 Pakuotės lapelis 2025 05 07, KR_1050.docx

4407 Carmustine Zentiva II PL 2025 05 07, KR_1050.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NO/H/0289/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Karmustinas	100 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
101993	88095	1088095	flakonas	milteliai ir tirpiklio flakonas (3 ml), N1		Receptinis	LT/1/19/4407/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-24	Perregistruotas
2019-07-02	Registruotas