Details

Product Name in the RMS: Buprenoratiopharm 35 Mikrogramm/Stunde Transdermales Pflaster

MR Number: DE/H/5078/001
Date of outcome: 30.11.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	buprenorphine 20 mg
Form	Transdermal patch
MA Holder in the RMS	ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany splitting procedure: New split procedure number is IS/H/0301/001-003/DC
RMS	Germany
Date of last change	15.12.2020
ATC-Code	N02AE01 Buprenorphine

CMS Country	Domestic Product Name
Austria	Buprenorphin ratiopharm 35 Mikrogramm/h transdermales Pflaster
Croatia	Buprenorfin Pliva 35 mikrograma/h transdermalni flaster
Finland
Netherlands	Buprenorfine Teva 35 microgram/uur, pleister voor transdermaal gebruik
Portugal
Spain
United Kingdom

Documents
PAR:	DE_H_5078_001_PAR.pdf (06.03.2017)
Finalised Product Information:	DE_H_5078_001_FinalPI_1of2.pdf (22.10.2020)
Finalised Product Information:	DE_H_5078_001_FinalPI_2of2.pdf (22.10.2020)