| Code | 2894B | ||||||||||
| MA number | 68/0232/07-S | ||||||||||
| Product Form: | tbl plg 100(100x1)x300 mg (blis.PCTFE/PVC/Al - jednotk.bal.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | CHEPLAPHARM Arzneimittel GmbH, Germany | ||||||||||
| Therapeutic Class: | 68 - ANTIPSYCHOTICA (NEUROLEPTICA) | ||||||||||
| ATC: |
|
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| Shelf life: | 36 | ||||||||||
| Container: | blister PCTFE/PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 28.06.2007 |
| Dokument: |
DHPC Seroquel XR metabolicke parametre 17 8 2012.pdf
|
| Dokument: |
Seroquel XR_Príručka pre lekára.pdf
|
| SPC: |
SPC_Seroquel XR_11_2024.pdf
|
| SPC: |
SPC_Seroquel XR_11_2024.docx
|
| PIL: |
PIL_Seroquel XR_11_2024.pdf
|
| Safety feature | Yes |
| Data update: | 28.11.2024 |
