Solu-Medrol 250 mg prašak i otapalo za otopinu za injekciju/infuziju
| Name | Solu-Medrol 250 mg prašak i otapalo za otopinu za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-551195641 |
| Active Substance | natrijev metilprednizolonsukcinat |
| Composition | jedna bočica sadrži 250 mg metilprednizolona u obliku natrijevog metilprednizolonsukcinata |
| Pharmaceutical Form | Prašak i otapalo za otopinu za injekciju / infuziju |
| Manufacturer | Pfizer Manufacturing Belgium NV, Puurs, Belgija |
| Marketing Authorisation Holder | Pfizer Croatia d.o.o., Slavonska avenija 6, Zagreb, Hrvatska |
| Marketing Authorisation Date | 20.07.2018 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 25.04.2024* |
| Classification Number | UP/I-530-09/16-02/465 |
| Registration Number | 381-12-01/30-18-06 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | H02AB04 |
| Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
| 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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 (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.
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o izmjeni formulacije lijeka Solu-Medrol 125 mg prašak i otapalo za otopinu za injekciju/infuziju (metilprednizolon) i Solu-Medrol 250 mg prašak i otapalo za otopinu za injekciju/infuziju (metilprednizolon) u formulaciju bez konzervansa benzilnog alkohola u otapalu te o mogućem riziku od medikacijske pogreške zbog promjene boje čepa aktivatora | 13.04.2021 | Pfizer Croatia d.o.o. |
