SAI - Detailed view

PAXLOVID Filmtabl 4x150mg/2x100mg 5 x 6 Stk

Drug

Name

Paxlovid, Filmtabletten

Field of application

Behandlung von COVID-19

ATC

J05AE30 - NIRMATRELVIR AND RITONAVIR

08.03.0. – antivirals

Use

HAM – Human medicine

pharmaceutical form

FILM – Film-coated tablet

Remedy code

S – synthetic products for human use

Dispensing categories

A – Dispensed once only on prescription by a physician or veterinarian (A)

Authorisation status

Z – approved

Authorisation number

68793

Initial registration date

6/15/2022

Expiry date

4/4/2029

Dosage strength

Name

Paxlovid, Filmtabletten

Field of application

Behandlung von COVID-19

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680687930017

Trade status*

No information made available

Status

A/R – Authorised / referenced

Package size

30 tablet(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component A)

Active substance

150 mg nirmatrelvirum

Excipient

cellulosum microcristallinum
185 mg lactosum monohydricum
carmellosum natricum conexum
silica colloidalis anhydrica
natrii stearylis fumaras
hypromellosum
E 171
macrogolum 400
E 172 (rubrum)
0.99 mg natrium

Component B)

Active substance

100 mg ritonavirum

Excipient

copovidonum
silica colloidalis anhydrica
sorbitani lauras
calcii hydrogenophosphas
natrii stearylis fumaras
hypromellosum
E 171
macrogolum 400
macrogolum 3350
hydroxypropylcellulosum
talcum
silica colloidalis anhydrica
polysorbatum 80
0.388 mg natrium