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Innovative TCM Jiuwei Cough Syrup Approved for Marketing by China NMPA
2024-02-21
Recently, the Category 1.1 innovative traditional Chinese medicine (TCM) Jiuwei Zhike Koufuye (cough syrup) of Zhuohe Pharmaceutical Group Co Ltd was approved for marketing by China NMPA.
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Crovalimab Injection Approved for Marketing by China NMPA
2024-02-07
Recently, the Crovalimab Injection (trade name: 派圣凯/Piasky) of Roche Pharma (Schweiz) AG was approved for marketing by China NMPA through the priority review and approval procedures. It is indicated for use in adults and adolescents (≥12 years old) with paroxysmal nocturnal hemoglobinuria who have not received complement inhibitor therapy.
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Tegileridine Fumarate Injection Approved for Marketing by China NMPA
2024-01-31
Recently, the Category 1 innovative product Tegileridine Fumarate Injection (trade name: 艾苏特) of Jiangsu Hengrui Pharmaceuticals Co., Ltd. was approved for marketing by China NMPA. It is indicated for moderate to severe pain after abdominal surgery.
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Ganagliflozin Proline Tablets Approved for Marketing by China NMPA
2024-01-19
Recently, the Category 1 innovative product Ganagliflozin Proline Tablets (trade name: 惠优静) of Jilin Huisheng Biopharmaceutical Co,. Ltd. was approved for marketing by China NMPA.
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Lecanemab Injection Approved for Marketing by China NMPA
2024-01-09
Recently, the Lecanemab Injection (trade name: 乐意保/Leqembi) of Eisai Inc. was approved for marketing by China NMPA through the priority review and approval procedures. It is indicated for the treatment of mild cognitive impairment and dementia caused by Alzheimer's disease.
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Promulgation of the Rules for the Application of Discretion in Imposing Administrative Penalties in the Supervision and Administration of Medicinal Products
2024-02-23
Recently, the Rules for the Application of Discretion in Imposing Administrative Penalties in the Supervision and Administration of Medicinal Products were issued by China NMPA, which will come into force from August 1, 2024 onwards.
