INCRELEX

Medicinal product

(Invented) name

INCRELEX

Active substance (s)

Mekaserminas

Strength

10 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H01AC03, Mecasermin

Marketing authorisation holder

Esteve Pharmaceuticals GmbH, Vokietija

Date of authorisation

2007-08-03

Date of renewal

Documents

Increlex informacija apie hipoglikemija.pdf

Increlex mokomoji medziaga pacientams.pdf

Increlex mokomoji medziaga sveikatos prieziuros specialistams.pdf

Increlex vartojimo instrukcija.pdf

Increlex dozavimo gaires.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

1 ml injekcinio tirpalo yra:	1 ml
Mekaserminas	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
25831	28423	1028423	flakonas	4 ml N1		Receptinis	EU/1/07/402/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-08-03	Registruotas