Protaphane FlexPen

Medicinal product

(Invented) name

Protaphane FlexPen

Active substance (s)

Insulinas, žmogaus

Strength

100 TV/ml

Pharmaceutical form

injekcinė suspensija užpildytame švirkštiklyje

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 pre-filled pen	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
27989	30529	1030529	užpildytas švirkštiklis	3 ml N1		Receptinis	EU/1/02/234/013	Netiekiama	-	-	No	-	-
6407	4382	1004382	užpildytas švirkštiklis	3 ml N5		Receptinis	EU/1/02/234/014	Netiekiama	-	-	No	-	-
27990	30530	1030530	užpildytas švirkštiklis	3 ml N10		Receptinis	EU/1/02/234/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-10-07	Registruotas