Blastomat

Medicinal product

(Invented) name

Blastomat

Active substance (s)

Temozolomidas

Strength

250 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

Alvogen IPCo S.a.r.l., Liuksemburgas

Date of authorisation

2012-11-16

Date of renewal

2018-09-10

Documents

3127_1_12 Blastomat kaps II PL 200826.docx

3127_1_12 Pakuotės lapelis 200826.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2431/006/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Temozolomidas	250 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
47564	61384	1061384	buteliukas	N5		Receptinis	LT/1/12/3127/010	Netiekiama	-	-	No	-	-
47565	61385	1061385	paketėlis	N5		Receptinis	LT/1/12/3127/011	Netiekiama	-	-	No	-	-
54334	68326	1068326	paketėlis	N20		Receptinis	LT/1/12/3127/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-09-30	Išregistruotas
2018-09-10	Perregistruotas
2012-11-16	Registruotas