Protaphane Penfill

Medicinal product

(Invented) name

Protaphane Penfill

Active substance (s)

Insulinas, žmogaus

Strength

100 TV/ml

Pharmaceutical form

injekcinė suspensija užtaise

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 cartridge	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
11124	15630	1015630	užtaisas	3 ml N1		Receptinis	EU/1/02/234/005	Netiekiama	-	-	No	-	-
27984	4377	1004377	užtaisas	3 ml N5		Receptinis	EU/1/02/234/006	Netiekiama	-	-	No	-	-
27985	30525	1030525	užtaisas	3 ml N10		Receptinis	EU/1/02/234/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-10-07	Registruotas