| Code | 41787 | ||||||||||
| MA number | 87/0274/04-S | ||||||||||
| Product Form: | sol inj 5x2 ml/10 µg (amp.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | AbbVie s.r.o., Slovakia | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 22.11.2004 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Zemplar_07.2020.doc
|
| PIL: |
PIL_Zemplar_07.2020.doc
|
| Safety feature | Yes |
| Data update: | 08.04.2019 |
