Imensa 500 mg tablete
| Name | Imensa 500 mg tablete |
|---|---|
| Marketing Authorisation Number | HR-H-062875489 |
| Active Substance | paracetamol |
| Composition | jedna tableta sadrži 500 mg paracetamola |
| Pharmaceutical Form | tableta |
| Manufacturer | APL Swift Services (Malta) Ltd., Birzebbugia, Malta |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 25.01.2024 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 04.07.2025* |
| Classification Number | UP/I-530-09/23-02/145 |
| Registration Number | 381-12-01/70-24-03 |
| Prescription | Medicinal product not subject to medical prescription |
| Distribution | Supply through pharmacies (community) and non-pharmacy outlets |
| Advertising to general public | allowed |
| ATC Code | N02BE01 |
| Marketing status | trajni prekid opskrbe |
| 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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 (Official Gazette No. 76/13), 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.
