Code | 49923 | ||||||||||
MA number | 78/0127/08-S | ||||||||||
Product Form: | tbl plg 28x36 mg (fľ.HDPE) | ||||||||||
MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
Type of procedure: | Mutual recognition procedure | ||||||||||
MAH, country: | Johnson & Johnson, s.r.o., Slovakia | ||||||||||
Therapeutic Class: | 78 - SYMPATHOMIMETICA | ||||||||||
ATC: |
|
||||||||||
Shelf life: | 36 | ||||||||||
Container: | bottle HDPE | ||||||||||
Route of admin.: | Oral use |
Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
Legal basis: | Article 8(3) application - known active substance |
MA issued: | 18.04.2008 |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_Concerta_tbl plg_11_2022.pdf |
PIL: | PIL_Concerta_tbl plg_11_2022.pdf |
Safety feature | Yes |
Data update: | 05.06.2020 |