Blastomat

Medicinal product

(Invented) name

Blastomat

Active substance (s)

Temozolomidas

Strength

100 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01AX03, Temozolomide

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2012-11-16

Date of renewal

2018-09-10

Documents

3127 Pakuotės lapelis 2022 05 14.docx

3127 Blastomat RPP 2022 05 14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2431/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Temozolomidas	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
47560	61380	1061380	buteliukas	N5		Receptinis	LT/1/12/3127/004	Netiekiama	-	-	No	-	-
47561	61381	1061381	paketėlis	N5		Receptinis	LT/1/12/3127/005	Tiekiama	-	-	No	-	-	Download
54332	68324	1068324	paketėlis	N20		Receptinis	LT/1/12/3127/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-10	Perregistruotas
2012-11-16	Registruotas