| MR编号 | NL/H/3777/001 |
|---|
| 药品名称 | Glatiramer acetate Mylan 40 mg/ml, solution for injection, pre-filled syringe |
|---|
| 活性成分 | - Glatiramer acetate 40.0 mg/ml
|
|---|
| 剂型 | Solution for injection in prefilled syringe |
|---|
| 上市许可持有人 | Mylan bv
Dieselweg 25
3752 LB Bunschoten
The Netherlands |
|---|
| 参考成员国 - 产品名称 | Netherlands (NL) |
|---|
| 互认成员国 - 产品名称 | - Germany (DE)
CLIFT 40 mg/ml Injektionslösung in einer Fertigspritze - Denmark (DK)
Copemyl - Belgium (BE)
Glatiramyl 40 mg/ml, oplossing voor injectie in een voorgevulde spuit - United Kingdom (Northern Ireland) (XI)
- Ireland (IE)
- France (FR)
- Spain (ES)
- Italy (IT)
- Greece (GR)
GLATIRAMER/MYLAN - Sweden (SE)
- Norway (NO)
Copemyl - Finland (FI)
- Portugal (PT)
- Cyprus (CY)
Glatiramer Mylan 40mg/ml solution for injection pre-filled syringe
|
|---|
| 许可日期 | 2017/10/03 |
|---|
| 最近更新日期 | 2025/01/07 |
|---|
| 药物ATC编码 | - L03AX13 glatiramer acetate
| 申请类型 | - TypeLevel1：Abridged
- TypeLevel2：Multiple (Copy) Application
- TypeLevel3：Other Generic application Art 10.3 Dir 2001/83/EC
- TypeLevel4：Chemical Substance
- TypeLevel5：Prescription Only
|
|---|
| 附件文件下载 | |
|---|
| 市场状态 | Positive |
|---|
|
|---|