Actraphane 50 (Penfill)

Medicinal product

(Invented) name

Actraphane 50 (Penfill)

Active substance (s)

Insulinas, žmogaus

Strength

100 TV/ml

Pharmaceutical form

injekcinė suspensija

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A10AD01, Insulin (human)

Marketing authorisation holder

Novo Nordisk A/S, Danija

Date of authorisation

2002-10-07

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Suspension for injection	1 ml
Insulinas, žmogaus	100 TV

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
24553	27204	1027204	užtaisas	3 ml, N1		Receptinis	EU/1/02/229/017	Netiekiama	-	-	No	-	-
24554	27205	1027205	užtaisas	3 ml, N5		Receptinis	EU/1/02/229/018	Netiekiama	-	-	No	-	-
24555	27206	1027206	užtaisas	3 ml, N10		Receptinis	EU/1/02/229/019	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-10-07	Registruotas