Maracex

Medicinal product

(Invented) name

Maracex

Active substance (s)

Morfino hidrochloridas

Strength

20 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į epidurinę ertmę, leisti į raumenis, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

N02AA01, Morphine

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2018-05-08

Date of renewal

Documents

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

EE/H/0246/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Morfino hidrochloridas	20 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
99454	85561	1085561	ampulė	1 ml N10	Receptinis	LT/1/18/4219/001	Tiekiama	-	-	No	-	-
99455	85562	1085562	ampulė	1 ml N50	Receptinis	LT/1/18/4219/002	Netiekiama	-	-	No	-	-
99456	85563	1085563	ampulė	5 ml N5	Receptinis	LT/1/18/4219/003	Netiekiama	-	-	No	-	-
99457	85564	1085564	ampulė	5 ml N10	Receptinis	LT/1/18/4219/004	Netiekiama	-	-	No	-	-
99458	85565	1085565	ampulė	10 ml N5	Receptinis	LT/1/18/4219/005	Netiekiama	-	-	No	-	-
99459	85566	1085566	ampulė	10 ml N10	Receptinis	LT/1/18/4219/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-05-08	Registruotas