欧盟互认程序药品(最近更新)
最近更新
| 产品名称 | MR编号 | 活性成份 | 剂型 | 上市许可持有人 | 获批日期 | 更新日期 | 参考成员国 | 有关成员国 |
|---|---|---|---|---|---|---|---|---|
| Sacubitril/Valsartan Vale 24 mg/26 mg film-coated tablets | SI/H/0308/001 | Sacubitril sodium 24.3 mg、Valsartan 25.7 mg | Film-coated tablet | Vale Pharmaceuticals LimitedDungarvan Enterprise Centre, Lower mainStreet, Dungarvan, Waterford, X35 FX45, Ireland | 2026-08-14 00:00:00 | 2026-09-13 00:00:00 | Slovenia | Denmark、Finland、France、Germany、Iceland、Ireland、Italy、Netherlands、Norway、Spain、Sweden |
| Sacubitril/Valsartan Vale 49 mg/51 mg film-coated tablets | SI/H/0308/002 | Sacubitril sodium 48.6 mg、Valsartan 51.4 mg | Film-coated tablet | Vale Pharmaceuticals LimitedDungarvan Enterprise Centre, Lower mainStreet, Dungarvan, Waterford, X35 FX45, Ireland | 2026-08-14 00:00:00 | 2026-09-13 00:00:00 | Slovenia | Denmark、Finland、France、Germany、Iceland、Ireland、Italy、Netherlands、Norway、Spain、Sweden |
| Sacubitril/Valsartan Vale 97 mg/103 mg film-coated tablets | SI/H/0308/003 | Sacubitril sodium 97.2 mg、Valsartan 102.8 mg | Film-coated tablet | Vale Pharmaceuticals LimitedDungarvan Enterprise Centre, Lower mainStreet, Dungarvan, Waterford, X35 FX45, Ireland | 2026-08-14 00:00:00 | 2026-09-13 00:00:00 | Slovenia | Denmark、Finland、France、Germany、Iceland、Ireland、Italy、Netherlands、Norway、Spain、Sweden |
| Sacazarti 24 mg/26 mg film-coated tablets | SI/H/0309/001 | Sacubitril sodium 24.3 mg、Valsartan 25.7 mg | Film-coated tablet | Vale Pharmaceuticals LimitedDungarvan Enterprise Centre, Lower mainStreet, Dungarvan, Waterford, X35 FX45, Ireland | 2026-08-14 00:00:00 | 2026-09-13 00:00:00 | Slovenia | Belgium、Bulgaria、Croatia、Cyprus、Czech Republic、Greece、Hungary、Luxembourg、Malta、Romania、Slovak Republic |
| Sacazarti 49 mg/51 mg film-coated tablets | SI/H/0309/002 | Sacubitril sodium 48.6 mg、Valsartan 51.4 mg | Film-coated tablet | Vale Pharmaceuticals LimitedDungarvan Enterprise Centre, Lower mainStreet, Dungarvan, Waterford, X35 FX45, Ireland | 2026-08-14 00:00:00 | 2026-09-13 00:00:00 | Slovenia | Belgium、Bulgaria、Croatia、Cyprus、Czech Republic、Greece、Hungary、Luxembourg、Malta、Romania、Slovak Republic |
| Sacazarti 97 mg/103 mg film-coated tablets | SI/H/0309/003 | Sacubitril sodium 97.2 mg、Valsartan 102.8 mg | Film-coated tablet | Vale Pharmaceuticals LimitedDungarvan Enterprise Centre, Lower mainStreet, Dungarvan, Waterford, X35 FX45, Ireland | 2026-08-14 00:00:00 | 2026-09-13 00:00:00 | Slovenia | Belgium、Bulgaria、Croatia、Cyprus、Czech Republic、Greece、Hungary、Luxembourg、Malta、Romania、Slovak Republic |
| Dapagliflozin Bioeel | DK/H/3706/002 | Dapagliflozin 10.0 mg | Film-coated tablet | Bioeel Manufacturing S.R.LStrada Bega 5dTarga Mures, Mures,540390, Romania | 2026-08-09 00:00:00 | 2026-09-08 00:00:00 | Denmark | Romania |
| Dapagliflozin Pharmaplot P.C. | DK/H/3712/002 | Dapagliflozin 10.0 mg | Film-coated tablet | Pharmaplot P.C.Kleisthenous And 40a Mouson St, Athens15344Greece | 2026-08-09 00:00:00 | 2026-09-08 00:00:00 | Denmark | Malta |
| Ezetimib/Atorvastatin Gebro 10 mg/20 mg | AT/H/1701/002 | Atorvastatin calcium trihydrate 20.0 mg、Ezetimibe 10.0 mg | Film-coated tablet | Gebro Pharma GmbH|Bahnhofbichl 13|6391 Fieberbrunn|Austria | 2026-08-06 11:20:55 | 2026-09-05 11:20:55 | Austria | Czech Republic |
| Ezetimib/Atorvastatin Gebro 10 mg/40 mg film | AT/H/1701/003 | Atorvastatin calcium trihydrate 40.0 mg、Ezetimibe 10.0 mg | Film-coated tablet | Gebro Pharma GmbH|Bahnhofbichl 13|6391 Fieberbrunn|Austria | 2026-08-06 11:20:54 | 2026-09-05 11:20:54 | Austria | Czech Republic |