DOLFORIN

Medicinal product

(Invented) name

DOLFORIN

Active substance (s)

Fentanilis

Strength

100 µg/val.

Pharmaceutical form

transderminis pleistras

Route (s) of administration

vartoti per odą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02AB03, Fentanyl

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2008-01-25

Date of renewal

2012-10-30

Documents

0989 Pakuotės lapelis 2024 05 05.docx

0989 DOLFORIN PCS 2024 06 13.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(1)

Procedure number

HU/H/0370/004

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Pleistre (aktyvaus paviršiaus plotas – 60 cm²) yra 19,2 mg fentanilio, atsipalaiduojančio	1 vnt.
Fentanilis	100 µg/val.

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
22980	4946	1004946	paketėlis	N5		Receptinis	LT/1/08/0989/010	Tiekiama	-	-	No	-	-	Download
22981	25713	1025713	paketėlis	N10		Receptinis	LT/1/08/0989/011	Netiekiama	-	-	No	-	-
22982	25714	1025714	paketėlis	N20		Receptinis	LT/1/08/0989/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-10-30	Perregistruotas
2008-01-25	Registruotas