Therapeutical category

Beta-lactam Antibiotics

Dosage Forms

Powder for oral suspension

Strength

125 mg + 31.25 mg (4:1) / 5ml

250 mg + 62.5 mg (4:1) / 5 ml

200 mg + 28.5 mg (7:1) / 5ml *

400 mg + 57 mg (7:1) / 5ml

600 mg + 42.9 mg (14:1) / 5ml

Qualifiers

EU-CTD

Climatic Zone II, Climatic Zone IV but for * still under development

Regulatory status

Dossier available for audit and new MA submission. EU MA's available. Repeat-use possibility.