Morphine hydrochloride Kalceks

Medicinal product

(Invented) name

Morphine hydrochloride Kalceks

Active substance (s)

Morfino hidrochloridas trihidratas

Strength

10 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02AA01, Morphine

Marketing authorisation holder

AS Kalceks, Latvija

Date of authorisation

2015-04-30

Date of renewal

2019-12-19

Documents

Morphine hydr BB_AR.pdf

3717 Morphine hydrochloride Kalceks RPP 2024 12 31.docx

3717 Pakuotės lapelis 2024 12 31.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Vienoje ampulėje (1 ml) yra:	1 ml
Morfino hidrochloridas trihidratas	10 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
58825	73041	1073041	ampulė	1 ml N10		Receptinis	LT/1/15/3717/001	Netiekiama	2025-10-18	2026-01-31	Yes	2025-10-23	2025-12-31	Download
61996	76368	1076368	ampulė	1 ml N100	ASPĮ	Receptinis	LT/1/15/3717/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-12-19	Perregistruotas
2015-04-30	Registruotas