| Code | 49918 | ||||||||||
| MA number | 78/0126/08-S | ||||||||||
| Product Form: | tbl plg 28x18 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: |
|
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| 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 |
| PIL: |
PIL_Concerta_01.2025.pdf
|
| SPC: |
SPC_Concerta_01.2025.doc.pdf
|
| Safety feature | Yes |
| Data update: | 05.06.2020 |
