Code | 3946E | ||||||||||
MA number | 07/0165/23-S | ||||||||||
Product Form: | tbl 8x500 mg (blis.PVC/PVDC/Al) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | AGmed s.r.o., Czechia | ||||||||||
Therapeutic Class: | 07 - ANALGETICA, ANTIPYRETICA | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
Container: | blister PVC/PVDC/Al | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product not subject to medical prescription. |
Legal basis: | Article 10(1) generic application |
MA issued: | 18.07.2023 |
Validity: | 18.07.2028 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
PIL: | PIL_Paracetamol AGmed 500 mg_07_2023_OTC.pdf |
PIL: | PIL_Paracetamol AGmed 500 mg_07_2023_Rx.pdf |
SPC: | SPC_Paracetamol AGmed 500 mg_07_2023.pdf |
Safety feature | Unknown |
Data update: | 18.07.2023 |