Gribero 75 mg tvrde kapsule
| Name | Gribero 75 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-957411455 |
| Active Substance | dabigatraneteksilatmesilat |
| Composition | jedna tvrda kapsula sadrži 75 mg dabigatraneteksilata u obliku dabigatraneteksilatmesilata |
| Pharmaceutical Form | Kapsula, tvrda |
| Packaging [MA Number for Packaging] | 10 kapsula u blisteru, u kutiji [HR-H-957411455-01] 30 kapsula u blisteru, u kutiji [HR-H-957411455-02] 60 kapsula u blisteru, u kutiji [HR-H-957411455-03] 100 kapsula u blisteru, u kutiji [HR-H-957411455-04] 180 kapsula u blisteru, u kutiji [HR-H-957411455-05] 200 kapsula u blisteru, u kutiji [HR-H-957411455-06] 10 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-957411455-07] 20 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-957411455-08] 30 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-957411455-09] 50 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-957411455-10] 60 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-957411455-11] 100 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-957411455-12] 180 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-957411455-13] 200 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-957411455-14] 180 kapsula (3 pakiranja sa 60 kapsula u blisteru s jediničnom dozom), u kutiji [HR-H-957411455-15] 100 kapsula (2 pakiranja sa 50 kapsula u blisteru s jediničnom dozom), u kutiji [HR-H-957411455-16] 60 kapsula u bočici, u kutiji [HR-H-957411455-17] |
| Manufacturer | Pharmadox Healthcare Limited, Paola, Malta
Salutas Pharma GmbH, Barleben, Njemačka |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 23.08.2023 |
| MA Period of Validity | 23.08.2028 |
| Classification Number | UP/I-530-09/20-01/183 |
| Registration Number | 381-12-01/171-23-07 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | B01AE07 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for healthcare professionals |
Vodič za propisivače lijeka pVTE, verzija 6 Vodič za propisivače lijeka pSPAF, DVT, PE, verzija 6 Vodič za propisivače lijeka pVTE pedijatrijska populacija, verzija 2 |
| Educational materials for patients / caregivers |
Kartica s upozorenjima za bolesnika |
