Pulmozyme

Medicinal product

(Invented) name

Pulmozyme

Active substance (s)

Dornazė alfa

Strength

2500 TV/2,5 ml

Pharmaceutical form

purškiamasis įkvepiamasis tirpalas

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R05CB13, Dornase alfa (desoxyribonuclease)

Marketing authorisation holder

UAB Roche Lietuva, Lietuva

Date of authorisation

1996-12-06

Date of renewal

2009-02-17

Documents

1470 Pulmozyme RPP 2024 04 03.docx

1470 Pakuotės lapelis 2024 04 03.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Ampulėje (2,5 ml) yra	2.5 ml
Dornazė alfa	2500 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
3728	2192	1002192	ampulė	2,5 ml, N6		Receptinis	LT/1/96/1470/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2009-02-17	Perregistruotas
1996-12-06	Registruotas