| MR编号 | SE/H/1710/001 |
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| 药品名称 | Sirkava |
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| 活性成分 | - tiotropium bromide 18.0 µg
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| 剂型 | Inhalation powder, hard capsule |
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| 上市许可持有人 | Viatris Limited, Ireland |
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| 参考成员国 - 产品名称 | Sweden (SE) Sirkava |
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| 互认成员国 - 产品名称 | - Denmark (DK)
- Germany (DE)
Tiotropium Lageman 18 Mikrogramm Hartkapsel mit Pulver zur Inhalation - Belgium (BE)
Tiotropium Mylan 18 microgram inhalatiepoeder in harde capsule - Netherlands (NL)
Tiotropium Mylan - Luxembourg (LU)
- Iceland (IS)
Sirkava 18 míkróg innöndunarduft, hart hylki - United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Liechtenstein (LI)
- Austria (AT)
Tiotropium Mylan 18 Mikrogramm Hartkapseln mit Pulver zur Inhalation - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Greece (GR)
- Norway (NO)
Sirkava - Finland (FI)
- Poland (PL)
Acopair - Latvia (LV)
Tiotropium Mylan 18 mikrogrami inhalācijas pulveris, cietās kapsulas - Lithuania (LT)
Tiotropium bromide Mylan 18 mikrogramų įkvepiamieji milteliai (kietosios kapsulės) - Estonia (EE)
TIOTROPIUM MYLAN - Hungary (HU)
TIOTROPIUM VIATRIS 18 mikrogramm inhalációs por kemény kapszulában - Bulgaria (BG)
- Cyprus (CY)
TIOTROPIUM LAGEMAN 18 MCG PDR FOR INH, HARD CAPS - Romania (RO)
- Slovakia (SK)
Sirkava 18 mikrogramov - Slovenia (SI)
- Malta (MT)
- Croatia (HR)
Acopair 18 mikrograma, prašak inhalata, tvrde kapsule
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| 许可日期 | 2018/09/27 |
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| 最近更新日期 | 2024/07/01 |
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| 药物ATC编码 | - R03BB04 tiotropium bromide
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| 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Initial Application
- TypeLevel3：Other Generic application Art 10.3 Dir 2001/83/EC
- TypeLevel4：Chemical Substance
- TypeLevel5：Prescription Only
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| 附件文件下载 | |
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| 市场状态 | Positive |
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