Nokdirna

Medicinal product

(Invented) name

Nokdirna

Active substance (s)

Desmopresinas

Strength

50 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/1507/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename geriamajame liofilizate yra	1 vnt.
Desmopresinas	50 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
61980	76352	1076352	dalomoji lizdinė plokštelė	N10x1		Receptinis	LT/1/16/3940/005	Netiekiama	-	-	No	-	-
66075	80596	1080596	dalomoji lizdinė plokštelė	N30x1		Receptinis	LT/1/16/3940/006	Netiekiama	-	-	No	-	-
66076	80597	1080597	dalomoji lizdinė plokštelė	N90x1		Receptinis	LT/1/16/3940/007	Netiekiama	-	-	No	-	-
66077	80598	1080598	dalomoji lizdinė plokštelė	N100x1		Receptinis	LT/1/16/3940/008	Netiekiama	-	-	No	-	-

Stadijos

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