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PRODUCT DETAIL

OxyNal 80 mg/40 mg

Code 6205E
MA number 65/0110/24-S
Product Form: tbl plg 60x80 mg/40 mg (blis.Al/PVC/PE/PVDC)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: STADA Arzneimittel AG, Germany
Therapeutic Class: 65 - ANALGETICA - ANODYNA
ATC:
N NERVOUS SYSTEM
N02 ANALGESICS
N02A OPIOIDS
N02AA Natural opium alkaloids
N02AA55 Oxycodone and naloxone
Shelf life: 36
Container: blister Al/PVC/PE/PVDC
Route of admin.: Oral use
Prescription Status: Medicinal product subject to special medical prescription with skew blue stripe.
Legal basis: Article 10(1) generic application
MA issued: 06.06.2024
Validity: 06.06.2029
Pediatric warnings: Yes
PIL: PIL_OxyNal 80 mg_40 mg_05_2024.pdf  
SPC: SPC_OxyNal 80 mg_40 mg_05_2024.pdf  
Safety feature Yes
Data update: 10.06.2024
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