Details

Product Name in the RMS: Bupre-HEXAL 7 Tage 5 Mikrogramm/Stunde transdermales Pflaster

MR Number: DE/H/4045/001
Date of outcome: 12.01.2016

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Other Chemical Substance Prescription Only
Active Substances	buprenorphine 5 µg/h
Form	Transdermal patch
MA Holder in the RMS	Hexal Aktiengesellschaft Industriestrasse 25 D-83607 Holzkirchen Germany
RMS	Germany
Date of last change	07.12.2018
ATC-Code	N02AE01 Buprenorphine

CMS Country	Domestic Product Name
Austria	Bupacal 5 Mikrogramm/h - transdermales Pflaster
Belgium	Buprenorfine Sandoz Wekelijks 5 microgram/uur pleister voor transdermaal gebruik
Czech Republic	Bupain Mite 5 mcg
Denmark	Buprenorphine "Sandoz"
Finland
Ireland
Luxembourg
Netherlands	Buprenorfine Sandoz 5 microgram/uur, pleister voor transdermaal gebruik
Norway	Bugnanto
Portugal
Spain
Sweden
United Kingdom	BupreHexal 7 Tage Matrixpf. 5 Mikrogramm/Stunde transdermales Pflaster

Documents
PAR:	DE_H_4045_001_PAR.pdf (22.05.2017)
Finalised Product Information:	DE_H_4045_001_FinalPI_1of2.pdf (07.11.2018)
Finalised Product Information:	DE_H_4045_001_FinalPI_2of2.pdf (07.11.2018)