EP8.7增补内容EP8.7增补内容 - 药群论坛

A vertical line in the margin indicates where part of a text has been revised or corrected. A horizontal line in the margin indicates where part of a text has been deleted. However, these indications, which are not necessarily exhaustive, are given for information and do not form an official part of the texts. Editorial changes are not indicated.

Subscribers to the current version (printed or electronic) of the European Pharmacopoeia have access to an archive version of all previous editions of the European Pharmacopoeia.

The texts below appear for the first time in the European Pharmacopoeia. They will be implemented on 1 April 2016 at the latest.

以下内容首次出现在欧洲药典中。最迟实施日期为2016年4月1日。

2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in active substances

5.21. Chemometric methods applied to analytical data 分析数据中应用的化学计量法

Haemophilus type b and meningococcal group C conjugate vaccine (2622)

Radiopharmaceutical preparations and starting materials for radiopharmaceutical preparations

The texts below have been technically revised since their last publication. They will be implemented on 1 April 2016.

2.5.38. Methyl, ethyl and isopropyl methanesulfonate in active substances

5.22. Names of herbal drugs used in traditional Chinese medicine 传统中药中所用草药名

The texts below have been corrected and are republished in their entirety. These corrections are to be taken into account from the publication date of Supplement 8.7 (1 October 2015).

以下内容进行了更正，全文重新发布。这些更正应从8.7增补公布日起考量（2015年10月1日）。

The texts below have undergone pharmacopoeial harmonisation (see chapter 5.8. Pharmacopoeial harmonisation).

以下内容已经过药典协调一致化评估（参见第5.8章药典协调）。

The title of the following text has been changed in Supplement 8.7.

Cisatracurium besilate (2763)	苯磺顺阿曲库胺
Dienogest (2732)	地诺孕素
Entecavir monohydrate (2815)	恩替卡韦一水合物
Gadobutrol monohydrate (2735)	钆布醇一水合物
Gefitinib (2866)	吉非替尼
Human C1-esterase inhibitor (2818)	人用C1酯酶抑制剂
Hydroxypropylcellulose, low-substituted (2083)	羟丙纤维素，低取代
Pregabalin (2777)	普瑞巴林
Rabeprazole sodium (2868)	雷贝拉唑钠<抗溃疡病药>
Rabeprazole sodium hydrate (2331)	雷贝拉唑钠水合物
Ropinirole hydrochloride (2604)	盐酸罗匹尼罗<抗震颤麻痹药>
Sitagliptin phosphate monohydrate (2778)	磷酸西格列汀一水合物
Sitagliptin tablets (2927)	西格列汀片剂
Sodium lauroylsarcosinate for external use (2542)	外用月桂酰肌氨酸钠
Thiocolchicoside crystallised from ethanol (2896)	乙醇中结晶的硫代秋水仙碱苷
Thiocolchicoside hydrate (2814)	硫代秋水仙碱苷水合物