Protaphane

Medicinal product

(Invented) name

Protaphane

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)

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	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
27981	30522	1030522	flakonas	10 ml N1		Receptinis	EU/1/02/234/003	Netiekiama	-	-	No	-	-
27982	30523	1030523	flakonas	10 ml N5		Receptinis	EU/1/02/234/004	Netiekiama	-	-	No	-	-
27983	30524	1030524	flakonas	10 ml N5 (5x1) (sudėtinė)		Receptinis	EU/1/02/234/017	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-10-07	Registruotas