Ketorolac Trometamol Rompharm

Medicinal product

(Invented) name

Ketorolac Trometamol Rompharm

Active substance (s)

Ketorolako trometamolis

Strength

30 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M01AB15, Ketorolac

Marketing authorisation holder

UAB Eletis Medica, Lietuva

Date of authorisation

2021-03-18

Date of renewal

Documents

1497-001-002_Ketorolac Trometamol Rompharm PZ_2021-03-18.docx

1497-001-002_Ketorolac Trometamol Rompharm PL_2021-03-18.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

Ampulėje (1 ml) yra	1 ml
Ketorolako trometamolis	30 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
106186	92287	1092287	ampulė	1 ml, N5		Receptinis	LT/L/21/1497/001	Netiekiama	-	-	No	-	-
106187	92288	1092288	ampulė	1 ml, N10		Receptinis	LT/L/21/1497/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-03-18	Registruotas