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Search results (20)

Zavicefta

INN or common name: ceftazidime; avibactam

Therapeutic area (MeSH): Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections

Marketing authorisation issued: 23 June 2016

Last updated: 14 November 2025

Revision: 20

Medicine Human Authorised

Emblaveo

INN or common name: aztreonam; avibactam

Therapeutic area (MeSH): Gram-Negative Bacterial Infections; Urinary Tract Infections; Healthcare-Associated Pneumonia; Soft Tissue Infections

Marketing authorisation issued: 22 April 2024

Last updated: 17 September 2025

Revision: 2

Medicine Human Authorised

PSUSA/00000832/202411 - periodic safety update report single assessment

Active substance(s) in scope of the PSUSA procedure: clotrimazole / metronidazole

Procedure number: PSUSA/00000832/202411

Regulatory outcome: Maintenance

Last updated: 31 July 2025

PSUSA Human

PSUSA/00010199/202405 - periodic safety update report single assessment

Active substance(s) in scope of the PSUSA procedure: bismuth subcitrate potassium / metronidazole / tetracycline

Procedure number: PSUSA/00010199/202405

Regulatory outcome: Variation

Last updated: 7 March 2025

PSUSA Human

PSUSA/00010199/201505 - periodic safety update report single assessment

Active substance(s) in scope of the PSUSA procedure: Bismuth subcitrate potassium / metronidazole / tetracycline

Procedure number: PSUSA/00010199/201505

Regulatory outcome: Variation