Details

Product Name in the RMS: Oxycodon comp.-AbZ 10 mg/5 mg Retardtabletten

MR Number: DE/H/4259/002
Date of outcome: 02.12.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	NALOXONE HYDROCHLORIDE hydrochloride 5,45 mg oxycodone hydrochloride 10 mg
Form	Prolonged release tablet
MA Holder in the RMS	splitting procedure: New split procedure number is IS/H/0304/001-005/DC AbZ-Pharma GmbH - Geschäftsanschrift - Graf-Arco-Str. 3 89079 Ulm Germany
RMS	Germany
Date of last change	11.01.2019
ATC-Code	N02AA55 oxycodone, combinations

CMS Country	Domestic Product Name
Bulgaria	Oxycodone/Naloxone Teva
Croatia	Oksikodon/nalokson Pliva 10 mg/5 mg tablete s produljenim oslobađanjem
Finland
Italy
Poland	Oxycodone + Naloxone Teva
Slovak Republic	Oxykodon/Naloxon Teva 10 mg/5 mg tablety s predĺženým uvoľňovaním
Spain
Sweden
United Kingdom

Documents
PAR:	DE_H_4259_002_PAR.pdf (25.07.2017)
Finalised Product Information:	DE_H_4259_002_FinalPI_1of2.pdf (06.12.2018)
Finalised Product Information:	DE_H_4259_002_FinalPI_2of2.pdf (06.12.2018)