| MR编号 | AT/H/0959/002 |
|---|
| 药品名称 | Risperidon Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension |
|---|
| 活性成分 | |
|---|
| 剂型 | Powder and solvent for prolonged-release suspension for injection |
|---|
| 上市许可持有人 | Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands |
|---|
| 参考成员国 - 产品名称 | Austria (AT) Risperidon ratiopharm 37,5 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension |
|---|
| 互认成员国 - 产品名称 | - Germany (DE)
Risperidon-ratiopharm 37,5 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension - Denmark (DK)
- Belgium (BE)
Risperidone Teva 37,5 mg Poeder en oplosmiddel voor suspensie voor injectie met verlengde afgifte - Netherlands (NL)
- Luxembourg (LU)
- Iceland (IS)
Risperidone Teva GmbH - France (FR)
- Spain (ES)
- Portugal (PT)
- Italy (IT)
- Sweden (SE)
- Norway (NO)
Risperidone Teva GmbH - Finland (FI)
- Poland (PL)
Risperidone Teva - Lithuania (LT)
Risperidone Teva 37,5 mg milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai - Hungary (HU)
Risperidone Teva 37,5 mg por és oldószer retard szuszpenziós injekcióhoz - Bulgaria (BG)
Speridan - Romania (RO)
Risperidonă Teva 37,5 mg pulbere și solvent pentru suspensie injectabilă cu eliberare prelungită
|
|---|
| 许可日期 | 2020/10/14 |
|---|
| 最近更新日期 | 2025/07/03 |
|---|
| 药物ATC编码 | | 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Initial Application
- TypeLevel3：Generic Art 10.1 and 10.2 Dir 2001/83/EC
- TypeLevel4：Chemical Substance
- TypeLevel5：Prescription Only
|
|---|
| 附件文件下载 | |
|---|
| 市场状态 | Positive |
|---|
|
|---|