Protaphane NovoLet

Medicinal product

(Invented) name

Protaphane NovoLet

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

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

1 ml tirpalo yra	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
11125	15631	1015631	užpildytas švirkštas	N5 x 3 ml (3.5 mg/ml)		Receptinis	EU/1/02/234/008	Netiekiama	-	-	No	-	-
27986	30526	1030526	užpildytas švirkštas	N10 x 3 ml (3.5 mg/ml)		Receptinis	EU/1/02/234/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2002-10-07	Registruotas