| MR编号 | DE/H/2619/002 |
|---|
| 药品名称 | BOCOUTURE 100 Einheiten Pulver zur Herstellung einer Injektionslösung |
|---|
| 活性成分 | - Clostridium botulinum type A neurotoxin complex 0.8 ng
|
|---|
| 剂型 | Powder for solution for injection |
|---|
| 上市许可持有人 | Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100
D-60318 Frankfurt am Main
Germany |
|---|
| 参考成员国 - 产品名称 | Germany (DE) BOCOUTURE 100 Einheiten Pulver zur Herstellung einer Injektionslösung |
|---|
| 互认成员国 - 产品名称 | - Denmark (DK)
- Romania (RO)
BOCOUTURE 100 unităţi pulbere pentru soluţie injectabilă - Estonia (EE)
- Slovenia (SI)
- Croatia (HR)
- Hungary (HU)
BOCOUTURE 100 egység por oldatos injekcióhoz - Malta (MT)
Bocouture Pdr for Soln for Injection 100units - Ireland (IE)
- Iceland (IS)
Bocouture - Liechtenstein (LI)
- Belgium (BE)
BOCOUTURE 100 eenheden poeder voor oplossing voor injectie - Netherlands (NL)
- Austria (AT)
BOCOUTURE 100 Einheiten Pulver zur Herstellung einer Injektionslösung - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Greece (GR)
BOCOUTURE® - Sweden (SE)
- Finland (FI)
- Poland (PL)
Bocouture - Czechia (CZ)
BOCOUTURE 100 JEDNOTEK PRÁŠEK PRO INJEKČNÍ ROZTOK - Slovakia (SK)
BOCOUTURE 100 jednotiek prášok na injekčný roztok - Luxembourg (LU)
- Bulgaria (BG)
BOCOTURE - Latvia (LV)
Bocouture 100 vienības pulveris injekciju šķīduma pagatavošanai - Cyprus (CY)
BOCOUTURE 100 μονάδες για ενέσιμο διάλυμα - Norway (NO)
|
|---|
| 许可日期 | 2016/08/18 |
|---|
| 最近更新日期 | 2025/09/07 |
|---|
| 药物ATC编码 | | 申请类型 | - TypeLevel1：Line Extension
- TypeLevel2：Additional Strength/Form
- TypeLevel3：Full Dossier Art 8.3(i) Dir 2001/83/EC
- TypeLevel4：Chemical Substance
- TypeLevel5：Prescription Only
|
|---|
| 附件文件下载 | |
|---|
| 市场状态 | Positive |
|---|
|
|---|