| MR编号 | UK/H/5802/001 |
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| 药品名称 | Paracetamol/Guaifenesin/Phenylephrine Hydrochloride Wrafton 250mg/100mg/5mg Tablets |
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| 活性成分 | - guaifenesin 100.0 mg
- paracetamol 250.0 mg
- PHENYLEPHRINE HYDROCHLORIDE 5.0 mg
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| 剂型 | Tablet |
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| 上市许可持有人 | Wrafton Laboratories Limited,
Braunton,
Devon,
EX33 2DL |
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| 参考成员国 - 产品名称 | United Kingdom (GB) Paracetamol, Guaifenesin, Phenylephrine HCL 250 mg/100 mg/5 mg Wrafton Film coated tablets |
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| 互认成员国 - 产品名称 | - Czechia (CZ)
Paracetamol/Guaifenesin/Phenylephrine Hydrochloride Wrafton Film Coated Tablets - Germany (DE)
Paracetamol/Guaifenesin/Phenylephrinhydrochlorid Wrafton 250 mg/100 mg/5 mg Filmtabletten - Spain (ES)
- Hungary (HU)
- Italy (IT)
- Poland (PL)
Paracetamol+Guaifenesin+Phenylephrine Hydrochloride Wrafton - Romania (RO)
- Slovakia (SK)
Paracetamol, Guajfenezín, Fenylefríniumchlorid Wrafton 250 mg/100 mg/5 mg, filmom obalené tablety
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| 许可日期 | 2015/11/20 |
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| 最近更新日期 | 2016/03/08 |
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| 药物ATC编码 | - N02BE51 paracetamol, combinations excl. psycholeptics
| 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| 市场状态 | Withdrawn（注：已撤市） 撤市原因：1.The company decided to withdraw the application. At the time of withdrawal, the MS considered that the data provided did not allow to conclude on a positive benefit-risk balance as major objections were raised. |
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