Medicines/Finished Pharmaceutical Products

• "+" means combination product, both fixed-dose combination (co-formulated) and co-packaged product (i.e. co-blister)
• [A+B] + C means A and B are in a fixed-dose formulation and C is co-packaged
• (a) means SRA-approved innovator or SRA-approved generic that has been prequalified based on abbreviated assessment
• "*" refers to products approved by both WHO and US FDA
• USFDA1 approved by US FDA
• USFDA2 tentatively approved by US FDA
• EMA Art. 58 - approved by EMA according to Article 58

Note:

• For information about the listing of prequalified products and the alternative approval procedure, please see: General Information