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Medicine

Paxlovid kit

Nirmatrelvir and Ritonavir · Pfizer Laboratories
Available on requestPrescription onlyUS FDA

Paxlovid kit is a prescription medicine containing Nirmatrelvir and Ritonavir, marketed by Pfizer Laboratories, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at USP controlled room temperature 20°C to 25°C (68°F to 77°F)…

Key facts

Active ingredient (INN)
Nirmatrelvir and Ritonavir
Brand
Paxlovid
Dosage form
Kit
Packs
10 blister pack, 1 blister pack and 2 more
Marketing authorisation holder
Pfizer Laboratories
Manufacturer
Pfizer Laboratories
Origin register
US FDA, United States
Storage
Store at USP controlled room temperature 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
J05AE30 Nirmatrelvir and Ritonavir
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
18 October 2023
Identifiers
RxCUI 900575, 2587897, 2587898 +5DailyMed set ID 8a99d6d6-fd9e-45bb-b1bf-48c7f761232aNDC 0069-5317, 0069-5321, 0069-5434 +2Application NDA217188

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

PackCodeLabelerMarketed since
10 blister pack in 1 carton / 1 kit in 1 blister pack * 2 tablet, film coated in 1 blister pack * 1 tablet, film coated in 1 blister pack0069-5045-30Pfizer Laboratories9 July 2025
10 blister pack in 1 carton / 1 kit in 1 blister pack * 1 tablet, film coated in 1 blister pack * 1 tablet, film coated in 1 blister pack0069-5317-20Pfizer Laboratories18 October 2023
10 blister pack in 1 carton / 1 kit in 1 blister pack * 2 tablet, film coated in 1 blister pack * 1 tablet, film coated in 1 blister pack0069-5321-30Pfizer Laboratories18 October 2023
10 blister pack in 1 carton / 1 kit in 1 blister pack * 1 tablet, film coated in 1 blister pack * 1 tablet, film coated in 1 blister pack0069-5434-20Pfizer Laboratories9 July 2025
1 blister pack in 1 carton / 1 kit in 1 blister pack * 6 tablet, film coated in 1 blister pack * 5 tablet, film coated in 1 blister pack0069-5450-11Pfizer Laboratories5 January 2026

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 25 May 2023Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Clinical summary

Nirmatrelvir and Ritonavir is a fixed-dose combination medicine indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. MedsAcross supplies Nirmatrelvir and Ritonavir for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Nirmatrelvir and Ritonavir

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Paxlovid kit for your hospital or patient?

Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.