Metamizolnatrij hidrat Bausch Health 500 mg filmom obložene tablete
| Name | Metamizolnatrij hidrat Bausch Health 500 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-821731665 |
| Active Substance | metamizolnatrij hidrat |
| Composition | svaka tableta sadrži 500 mg metamizolnatrij hidrata |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | ICN Polfa Rzeszow S.A, Rzeszow, Poljska |
| Marketing Authorisation Holder | Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Irska |
| Marketing Authorisation Date | 31.07.2023 |
| MA Period of Validity | 31.07.2028 |
| MA Revocation Date | 06.07.2026* |
| Classification Number | UP/I-530-09/22-01/125 |
| Registration Number | 381-12-01/154-23-10 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for non-renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | N02BB02 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o važnim mjerama za minimizaciju ozbiljnih ishoda poznatog rizika od agranulocitoze uz primjenu lijekova koji sadrže metamizol | 09.12.2024 | Alkaloid d.o.o., Pliva Hrvatska d.o.o., Bausch Health Poland sp. z.o.o |
