| Code | 1978A | ||||||||||
| MA number | 87/0326/12-S | ||||||||||
| Product Form: | con inf 1x5 ml/4 mg (5 ml liek.inj.plast.-COP) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Vipharm S.A., Poland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | vial | ||||||||||
| Route of admin.: | Intravenous use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 29.06.2012 | 
| PIL: |  | 
| SPC: |  | 
| Safety feature | Yes | 
| Data update: | 15.05.2018 |