| Code | 97607 | ||||||||||
| MA number | 68/0107/03-S | ||||||||||
| Product Form: | plu igf 1x50 mg+1x solv.(liek.inj.skl.+liek.inj.+adaptér na liekovku) | ||||||||||
| 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: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: |
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| Shelf life: | 36 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intramuscular use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 28.04.2003 |
| Pediatric warnings: | Yes |
| Dokument: |
DHPC risperidon_paliperidon 10 10 2013.pdf
|
| Dokument: |
DHPC Risperdal Consta 24 5 2010.pdf
|
| SPC: |
SPC_RISPERDAL CONSTA_06_2021.pdf
|
| PIL: |
PIL_RISPERDAL CONSTA_06_2021.pdf
|
| Safety feature | Yes |
| Data update: | 08.04.2019 |
