Code | 4887D | ||||||||||
MA number | 78/0144/20-S | ||||||||||
Product Form: | tbl plg 30x54 mg (fľ.HDPE) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | Neuraxpharm Bohemia s.r.o., Czechia | ||||||||||
Therapeutic Class: | 78 - SYMPATHOMIMETICA | ||||||||||
ATC: |
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Shelf life: | 48 | ||||||||||
Container: | bottle HDPE | ||||||||||
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: | 21.07.2020 |
Validity: | 21.07.2025 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Metylfenidát Neuraxpharm_tbl plg_03_2023.pdf |
PIL: | PIL_Metylfenidát Neuraxpharm_tbl plg_03_2023.pdf |
Safety feature | Yes |
Data update: | 21.10.2020 |