Hydromorphone Kalceks

Medicinal product

(Invented) name

Hydromorphone Kalceks

Active substance (s)

Hidromorfono hidrochloridas

Strength

50 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02AA03, Hydromorphone

Marketing authorisation holder

AS KALCEKS, Latvija

Date of authorisation

2018-12-14

Date of renewal

Documents

4305_4306_4307_4308 Hydromorphone Kalceks PCS 200529.docx

4305_4307_4308_1_2, 4306_1_4 Pakuotės lapelis 200320.docx

Stage

Išregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

EE/H/0258/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Hidromorfono hidrochloridas	50 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
100682	86792	1086792	ampulė	1 ml N5		Receptinis	LT/1/18/4308/001	Netiekiama	-	-	No	-	-
100683	86793	1086793	ampulė	1 ml N10		Receptinis	LT/1/18/4308/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-07	Išregistruotas
2018-12-14	Registruotas