Amlopin 5 mg tablete
| Name | Amlopin 5 mg tablete |
|---|---|
| Former Name | Amlodipin Sandoz 5 mg tablete |
| Marketing Authorisation Number | HR-H-011308058 |
| Active Substance | amlodipinbesilat |
| Composition | jedna tableta sadrži 5 mg amlodipina u obliku amlodipinbesilata |
| Pharmaceutical Form | tableta |
| Packaging [MA Number for Packaging] | 30 tableta u blisteru, u kutiji [HR-H-011308058-01] 60 tableta u blisteru, u kutiji [HR-H-011308058-02] 90 tableta u blisteru, u kutiji [HR-H-011308058-03] |
| Manufacturer | Lek Pharmaceuticals d.d., Ljubljana, Slovenija
Lek Pharmaceuticals d.d., Lendava, Slovenija Lek S.A., Strykow, Poljska |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 08.03.2017 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/16-02/145 |
| Registration Number | 381-12-01/70-17-05 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C08CA01 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o izmjeni formulacije, izgleda tablete i vrste primarnog pakiranja (blistera) za lijekove Amlopin 5 mg tablete i Amlopin 10 mg tablete (amlodipinbesilat) | 02.08.2021 | Sandoz d.o.o. |
