Remolexam

Medicinal product

(Invented) name

Remolexam

Active substance (s)

Meloksikamas

Strength

15 mg/1,5 ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M01AC06, Meloxicam

Marketing authorisation holder

Vital Pharma GmbH, Vokietija

Date of authorisation

2017-05-16

Date of renewal

Documents

4082_5_6 Pakuotės lapelis 190514.docx

Remolexam inj_LT_111_DC_ PAR.pdf

4082_5_6 Remolexam_inj II PL 190514.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0111/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Ampulėje (1,5 ml tirpalo) yra	1.5 ml
Meloksikamas	15 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
64107	78554	1078554	ampulė	1,5 ml N3		Receptinis	LT/1/17/4082/005	Netiekiama	-	-	No	-	-
68327	82902	1082902	ampulė	1,5 ml N5		Receptinis	LT/1/17/4082/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-29	Išregistruotas
2017-05-16	Registruotas