Details
Product Name in the RMS: Oxycodon comp.-AbZ 5 mg/2,5 mg Retardtabletten
MR Number: DE/H/4259/001
Date of outcome: 02.12.2015
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Generic Chemical Substance Prescription Only |
Active Substances |
NALOXONE HYDROCHLORIDE hydrochloride 2,74 mg oxycodone hydrochloride 5 mg |
Form | Prolonged release tablet |
MA Holder in the RMS |
AbZ-Pharma GmbH - Geschäftsanschrift - Graf-Arco-Str. 3 89079 Ulm Germany |
RMS | Germany |
Date of last change | 07.06.2020 |
ATC-Code |
N02AA55 oxycodone, combinations |
CMS Country | Domestic Product Name |
---|---|
Croatia | Oksikodon/nalokson Pliva 5 mg/2,5 mg tablete s produljenim oslobađanjem |
Finland | |
Italy | |
Poland | Oxycodone + Naloxone Teva |
Slovak Republic | Oxykodon/Naloxon Teva 5 mg/2,5 mg tablety s predĺženým uvoľňovaním |
Spain | |
Sweden | |
United Kingdom |
Documents | |
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PAR: | DE_H_4259_001_PAR.pdf (25.07.2017) |
Finalised Product Information: | DE_H_4259_001_FinalPI_1of2.pdf (06.12.2018) |
Finalised Product Information: | DE_H_4259_001_FinalPI_2of2.pdf (06.12.2018) |