| MR编号 | NL/H/0299/001 |
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| 药品名称 | Spiriva 18 microgram |
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| 活性成分 | - Tiotropium bromide monohydrate 22.5 µg
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| 剂型 | Inhalation powder, hard capsule |
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| 上市许可持有人 | Boehringer Ingelheim International GmbH
Bingerstrasse 173
D-55216 Ingelheim am Rhein
Germany |
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| 参考成员国 - 产品名称 | Netherlands (NL) Spiriva 18 microgram, inhalatiepoeder in harde capsules |
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| 互认成员国 - 产品名称 | - Liechtenstein (LI)
- Germany (DE)
- Denmark (DK)
- Belgium (BE)
- Luxembourg (LU)
- Iceland (IS)
- United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- Austria (AT)
Spiriva 18µg - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Greece (GR)
- Sweden (SE)
- Norway (NO)
- Finland (FI)
- Latvia (LV)
- Lithuania (LT)
Spiriva 18 mikrogramų įkvepiamieji milteliai (kietosios kapsulės) - Hungary (HU)
SPIRIVA 18 mikrogramm inhalációs por kemény kapszulában - Bulgaria (BG)
Spiriva - Cyprus (CY)
SPIRIVA INHALATION PWD HARD CAPS - Czechia (CZ)
Spiriva - Romania (RO)
Spiriva 18 micrograme capsule cu pulbere de inhalat - Slovakia (SK)
Spiriva - Slovenia (SI)
- Malta (MT)
Spiriva 18 microgram, inhalation powder, hard capsule
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| 许可日期 | 2002/04/02 |
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| 最近更新日期 | 2025/03/17 |
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| 药物ATC编码 | | 申请类型 | - TypeLevel1：New Active Substance
- TypeLevel2：Initial Application
- TypeLevel3：Full Dossier Article 4.8 Di 65/65
- 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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