Nokdirna

Medicinal product

(Invented) name

Nokdirna

Active substance (s)

Desmopresinas

Strength

25 µg

Pharmaceutical form

geriamasis liofilizatas

Route (s) of administration

vartoti po liežuviu

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H01BA02, Desmopressin

Marketing authorisation holder

Ferring GmbH, Vokietija

Date of authorisation

2016-07-22

Date of renewal

2021-07-05

Documents

3940_pakuotes lapelis_2021-07-05.docx

3940_Nokdirna_perr2021-07-05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1507/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename geriamajame liofilizate yra	1 vnt.
Desmopresinas	25 µg

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
61979	76351	1076351	dalomoji lizdinė plokštelė	N10x1		Receptinis	LT/1/16/3940/001	Netiekiama	-	-	No	-	-
66072	80593	1080593	dalomoji lizdinė plokštelė	N30x1		Receptinis	LT/1/16/3940/002	Netiekiama	-	-	No	-	-
66073	80594	1080594	dalomoji lizdinė plokštelė	N90x1		Receptinis	LT/1/16/3940/003	Netiekiama	-	-	No	-	-
66074	80595	1080595	dalomoji lizdinė plokštelė	N100x1		Receptinis	LT/1/16/3940/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-07-05	Perregistruotas
2016-07-22	Registruotas