Nirmatrelvir / Ritonavir (2) – Paxlovid®
COVID-19, no need for supplemental oxygen, aged ≥ 6 years to < 18 years, weighing ≥ 20 kg
Characteristics
| Start date | 15.12.2025 – Marketing authorisation: 26.11.2025 |
|---|---|
| Resolution | 04.06.2026 |
| INN | Nirmatrelvir/Ritonavir |
| Brand name | Paxlovid® |
| Pharm. company | Pfizer Pharma GmbH |
| G-BA Procedure ID | D-1276 |
| ATC code | J05AE30 Protease inhibitors (J05AE) |
| ICD-10 codes (AIS) | J06.9Upper respiratory disease, acute |
| Alpha-ID codes (AIS) | I4988Acute infection of the upper respiratory tract |
| Therapeutic area | Infectious diseases |
| Reason for procedure | New therapeutic indication |
| Therapeutic indication of the resolution |
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Paxlovid is used to treat coronavirus disease 2019 (COVID-19) in paediatric patients aged 6 years and over but under < 18 years of age, weighing at least 20 kg, who do not require supplemental oxygen and are at increased risk of developing severe COVID-19. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Kinder und Jugendliche ab 6 bis < 18 Jahre, die keine zusätzliche Sauerstoffzufuhr benötigen und ein erhöhtes Risiko haben, einen schweren COVID-19-Verlauf zu entwickeln |
Studies and Results
Children and adolescents aged 6 to < 18 years with a body weight of at least 20 kg who do not require supplemental oxygen and are at increased risk of developing severe COVID-19
- The additional benefit is not proven.
- In its dossier, the pharmaceutical manufacturer has not submitted any data for the assessment of the additional benefit of nirmatrelvir/ritonavir compared with the appropriate comparator therapy.
- Overall, there are therefore no data available to assess the additional benefit of nirmatrelvir/ritonavir for the treatment of coronavirus disease 2019 (COVID-19) in children and adolescents aged 6 to < 18 years with a body weight of at least 20 kg, who do not require supplemental oxygen and are at increased risk of developing severe COVID-19.
- Overall assessment
- The pharmaceutical manufacturer has not submitted any data to demonstrate the additional benefit of nirmatrelvir/ritonavir compared with remdesivir. Consequently, additional benefit from nirmatrelvir/ritonavir for the treatment of children and adolescents aged 6 to < 18 years with a body weight of at least 20 kg who do not require supplemental oxygen and are at increased risk of developing severe COVID-19 is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Nirmatrelvir / Ritonavir (2) | Paxlovid® | Pfizer Pharma GmbH | COVID-19, no need for supplemental oxygen, aged ≥ 6 years to < 18 years, weighing ≥ 20 kg | 40–230 | 100% additional benefit not proven | |
| Nirmatrelvir / Ritonavir (1) | Paxlovid® | Pfizer Pharma GmbH | COVID-19, no need for supplementary oxygen, increased risk of severe progression | 218,000–1,307,000 | 100% Hint for considerable additional benefit |
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