On September 9, China's National Health Commission (NHC), Ministry of Industry and Information Technology (MIIT), National Healthcare Security Administration (NHSA), and National Medical Products Administration (NMPA) jointly announced the Fifth List of Pediatric Drugs Encouraged for R&D and Marketing Authorization, containing 15 drugs in total.
This List focuses on medications for young children and emergencies, prioritizing those that address significant clinical challenges. It includes various pediatric-friendly formulations and dosages, as well as some drugs for rare diseases.
No. | Name (CN) | Name (EN) | Dosage Form | Strength |
1 | 阿尼芬净 | anidulafungin | Injection | 0.1g |
Injection | 0.05g | |||
2 | 柯拉特龙 | clascoterone | Cream | 1% |
3 | 头孢罗膦 | ceftaroline fosamil | Injection | 0.4g |
4 | 艾伐卡托 | ivacaftor | Granule | 25mg |
Granule | 50mg | |||
Granule | 75mg | |||
5 | 阿托伐他汀 | atorvastatin | Suspension | 5ml:20mg |
6 | 达比加群酯 | dabigatran etexilate | Pellet | 0.11g |
Pellet | 0.15g | |||
Pellet | 0.02g | |||
Pellet | 0.03g | |||
Pellet | 0.04g | |||
Pellet | 0.05g | |||
7 | 索利那新 | solifenacin | Suspension | 1ml:1mg |
8 | 托吡酯 | topiramate | Oral solution | 1ml:25mg |
9 | 托法替布 | tofacitinib | Oral solution | 1ml:1mg |
10 | 伊伐雷定 | ivabradine | Oral solution | 5ml:5mg |
11 | 氨曲南 | aztreonam | Inhalation solution | 75mg |
12 | 谷卡匹酶 | glucarpidase | Injection | 1000IU |
13 | 舒噻美 | sultiame | Oral suspension | 20mg/ml |
14 | 卡拉西珠单抗 | caplacizumab | Injection | 10mg |
15 | 瑞利珠单抗 | ravulizumab | Injection | 30ml:0.3g |
Injection | 3ml:0.3g | |||
Injection | 11ml:1.1g |
The NHC states that it will prioritize reviewing and approving pediatric drugs in the List and adding the qualified drugs to the National Essential Drug Catalog or National Reimbursement Drug List (NRDL).
Contact BaiPharm if you’d like to know all the Lists of Pediatric Drugs Encouraged for Development and Marketing Authorization.
