Protaphane

Medicinal product

(Invented) name

Protaphane

Active substance (s)

Insulinas, žmogaus

Strength

40 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)

A10AC01, 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 in vial	1 ml
Insulinas, žmogaus	40 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
27978	30519	1030519	flakonas	10 ml N1		Receptinis	EU/1/02/234/001	Netiekiama	-	-	No	-	-
27979	30520	1030520	flakonas	10 ml N5		Receptinis	EU/1/02/234/002	Netiekiama	-	-	No	-	-
27980	30521	1030521	flakonas	10 ml N5 (5x1)		Receptinis	EU/1/02/234/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-10-07	Registruotas