DOLFORIN

Medicinal product

(Invented) name

DOLFORIN

Active substance (s)

Fentanilis

Strength

25 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/0370/001

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Viename pleistre (15 cm²) yra 4,8 mg fentanilio, atsipalaiduojančio	1 vnt.
Fentanilis	25 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
22989	4949	1004949	paketėlis	N5		Receptinis	LT/1/08/0989/001	Tiekiama	-	-	No	-	-
22990	25719	1025719	paketėlis	N10		Receptinis	LT/1/08/0989/002	Netiekiama	-	-	No	-	-
22991	25720	1025720	paketėlis	N20		Receptinis	LT/1/08/0989/003	Netiekiama	-	-	No	-	-

Stadijos

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