Abstral 100 mikrograma sublingvalne tablete
| Name | Abstral 100 mikrograma sublingvalne tablete |
|---|---|
| Marketing Authorisation Number | HR-H-032023628 |
| Active Substance | fentanylum |
| Pharmaceutical Form | sublingvalna tableta |
| Strength | 100 mikrograma |
| Packaging [MA Number for Packaging] | 10 tableta u blisteru, u kutiji [HR-H-032023628-01] |
| Manufacturer | Recipharm Stockholm AB, Jordbro, Švedska;
Aesica Queenborough Limited, Queenborough, Kent, Ujedinjeno Kraljevstvo |
| Marketing Authorisation Holder | PharmaSwiss d.o.o., Strojarska 20, Zagreb |
| Marketing Authorisation Date | 28.04.2017 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 07.05.2018* |
| Classification Number | UP/I-530-09/16-02/226 |
| Registration Number | 381-12-01/70-17-07 |
| Composition | jedna sublingvalna tableta sadrži 100 mikrograma fentanila (u obliku citrata) |
| Prescription | na recept |
| Type of prescription | poseban recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N02AB03 |
| Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
| SmPC | download |
| PL | download |
| Educational materials for healthcare professionals |
Vodič za propisivače, verzija 2 Vodič za farmaceute, verzija 2 |
| Educational materials for patients / caregivers |
Vodič za bolesnike i njegovatelje, verzija 2 |
*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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
