| Code | 3320D | ||||||||||
| MA number | 48/0503/13-S | ||||||||||
| Product Form: | sol iru 10x15 ml (striek.inj.plast.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| Therapeutic Class: | 48 - DIAGNOSTICA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - known active substance |
| MA issued: | 03.01.2014 |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Dotarem prefilled syringes_01.2020.doc
|
| PIL: |
PIL_Dotarem prefilled syringes_01.2020.doc
|
| Safety feature | No |
| Data update: | 13.01.2020 |
