Mialdex

Medicinal product

(Invented) name

Mialdex

Active substance (s)

Deksketoprofenas

Strength

50 mg/2 ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M01AE17, Dexketoprofen

Marketing authorisation holder

UAB Inteli Generics Nord, Lietuva

Date of authorisation

2016-02-09

Date of renewal

2021-06-17

Documents

3500 Pakuotės lapelis inj_inf 2025 09 17.docx

Mialdex inj_AR.pdf

3500 Mialdex inj_inf PCS PL 2025 09 17.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Vienoje ampulėje (2 ml) yra	2 ml
Deksketoprofenas	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
61474	75794	1075794	ampulė	2 ml N5		Receptinis	LT/1/14/3500/004	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-06-17	Perregistruotas
2016-02-09	Registruotas