Neurobion 100 mg/100 mg/1 mg otopina za injekciju
| Name | Neurobion 100 mg/100 mg/1 mg otopina za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-687150760 |
| Active Substance | tiaminijev klorid piridoksinklorid cijanokobalamin |
| Composition | 3 ml otopine za injekciju (1 ampula) sadrži 100 mg tiaminklorida (vitamin B1), 100 mg piridoksinklorida (vitamin B6) i 1 mg cijanokobalamina (vitamin B12) |
| Pharmaceutical Form | otopina za injekciju |
| Manufacturer | Cenexi Hsc, Herouville Saint Clair, Francuska |
| Marketing Authorisation Holder | P&G Health Germany GmbH, Sulzbacher Strasse 40, Schwalbach am Taunus, Njemačka |
| Marketing Authorisation Date | 01.04.2020 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 25.03.2025* |
| Classification Number | UP/I-530-09/17-02/497 |
| Registration Number | 381-12-01/154-20-12 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | A11DB |
| Marketing status | Not marketed |
| SmPC | download |
| PL | download |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act, only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
