Ceftolozan / Tazobactam (7) – Zerbaxa®
Bacterial infections, multiple indications, < 18 years of age
Characteristics
| Start date | 15.08.2022 – Marketing authorisation: 25.07.2022 |
|---|---|
| Resolution | 02.02.2023 |
| INN | Ceftolozan/Tazobactam |
| Brand name | Zerbaxa® |
| Pharm. company | MSD SHARP & DOHME GMBH |
| G-BA Procedure ID | D-851 |
| ATC code | J01DI54 Other cephalosporins and penems (J01DI) |
| ICD-10 codes (AIS) | N10Acute pyelonephritis, N11.0Nonobstructive reflux-associated chronic pyelonephritis, N11.1Chronic obstructive pyelonephritis, N11.8Nonobstructive chronic pyelonephritis NOS, N11.9Chronic interstitial nephritis NOS, N12Tubulo-interstitial nephritis, not specified as acute or chronic, N13.60, N13.61, N13.62, N13.63, N13.64, N13.65, N13.66, N13.67, N13.68, N15.10, N15.9Renal tubulo-interstitial disease, unspecified, N28.88, N30.0Acute cystitis, N30.1Interstitial cystitis (chronic), N30.2Other chronic cystitis, N30.3Urethrotrigonitis, N30.80, N30.88, N30.9Cystitis, unspecified, N34.0Urethral abscess, N34.1Nongonococcal urethritis, N34.2Meatitis, urethral, N39.0Urinary tract infection, site not specified, N41.3Prostatocystitis, O23.0Pyelonephritis in pregnancy, O23.1Infections of bladder in pregnancy, O23.2Infections of urethra in pregnancy, O23.3Infections of other parts of urinary tract in pregnancy, O23.4Unspecified infection of urinary tract in pregnancy, O23.9Genitourinary tract infection in pregnancy NOS, O86.2Urinary tract infection following delivery, O86.3, T83.5Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| Alpha-ID codes (AIS) | I100314Hydronephrosis with ureteral stricture and infection, I108367Urinary tract infection during pregnancy, I108412Pyelocystitis during pregnancy, I117108Inflammation due to bladder catheter, I131040Hydronephrosis with infection of the kidney, I131041Hydronephrosis due to obstruction by stone, with infection of the kidney, I131042Hydroureter with infection of the kidney, I131044Hydronephrosis in ureteropelvic obstruction with infection of the kidney, I131046Hydronephrosis in obstruction due to kidney stone with infection of the kidney, I131047Hydronephrosis in obstruction due to ureteral calculi with infection of the kidney, I13283Urinary bladder abscess, I13588Cystitis, I15694Urinary tract infection n.e.c, I19495Kidney abscess, I19728Kidney infection, I20451Reflux pyelonephritis, I21736Prostatocystitis, I21834Pyelonephritis, I21837Acute bacterial pyelonephritis, I21841Recurrent pyelonephritis, I22426Trigonum cystitis, I22589Ureteral infection, I22701Urethral abscess, I22872Urethritis, I23169Acute cystitis, I23174Chronic cystitis, I23178Chronic interstitial cystitis, I24324Pyonephrosis, I7138Bacterial cystitis, I7148Nonspecific urethritis, I7831Infection of the urogenital tract during pregnancy, I7832Kidney infection during pregnancy, I7840Urinary bladder infection during pregnancy, I7843Urethra infection during pregnancy, I8335Postpartum infection of the urinary tract, I88696Non-obstructive chronic pyelonephritis, I89137Postpartum infection of the urogenital tract, I95572Ureteral constriction with infection, I97005Pyelonephritis with obstruction |
| DDD | 3 g P |
| Therapeutic area | Infectious diseases Antibiotikatherapie, Complicated intra-abdominal infections (cIAI) |
| Reason for procedure | New therapeutic indication – Reserve antibiotic |
| Regulatory status | Reserve antibiotic |
| Therapeutic indication of the resolution |
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|
Zerbaxa is indicated for the treatment of the following infections in pediatric patients: – Complicated intra-abdominal infections; – Acute pyelonephritis; – Complicated urinary tract infections. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Pediatric patients with complicated intra-abdominal infections. | |
| b) | Pediatric patients with acute pyelonephritis. | |
| c) | Pediatric patients with complicated urinary tract infection. |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted |
| Reason for dividing into subpopulations (G-BA) | Other |
a) Paediatric patients with complicated intra-abdominal infections
- The additional benefit is deemed proven.
- For the medicinal product Zerbaxa, containing the combination of active substances ceftolozan andtazobactam, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, points 2 and 3 of SGB V was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
- Where the Federal Joint Committee has decided to grant an exemption for a reserve antibiotic pursuant to Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).
b) Paediatric patients with acute pyelonephritis
- The additional benefit is deemed proven.
- For the medicinal product Zerbaxa, containing the combination of active substances ceftolozan/tazobactam, an exemption from the obligation to submit evidence pursuant to Section 35a(1), third sentence, numbers 2 and 3 of SGB V was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
- If the Federal Joint Committee (G-BA) has decided to grant an exemption for a reserve antibiotic in accordance with Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).
c) Paediatric patients with complicated urinary tract infections
- The additional benefit is deemed proven.
- For the medicinal product Zerbaxa, containing the combination of active substances ceftolozane/tazobactam, an exemption from the obligation to submit evidence pursuant to Section 35a(1), third sentence, numbers 2 and 3 of SGB V was granted by resolution of 20 January 2022, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
- Where the Federal Joint Committee (G-BA) has decided to grant an exemption for a reserve antibiotic pursuant to Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven; the extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).
Courtesy translation only, please refer to the German original.
Associated procedures
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