Paxlovid

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

nirmatrelvir, ritonavir

Saatavilla:

Pfizer Europe MA EEIG

ATC-koodi:

J05AE30

INN (Kansainvälinen yleisnimi):

nirmatrelvir, ritonavir

Terapeuttinen alue:

COVID-19 virus infection

Käyttöaiheet:

Paxlovid is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID 19.

Tuoteyhteenveto:

Revision: 15

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2022-01-28

Pakkausseloste

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Paxlovid 150 mg + 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pink film-coated tablet contains 150 mg of nirmatrelvir.
Each white film-coated tablet contains 100 mg of ritonavir.
Excipients with known effect
Each pink 150 mg film-coated tablet of nirmatrelvir contains 176 mg of
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Nirmatrelvir
Film-coated tablet (tablet).
Pink, oval, with a dimension of approximately 17.6 mm in length and
8.6 mm in width debossed with
‘PFE’ on one side and ‘3CL’ on the other side.
Ritonavir
Film-coated tablet (tablet).
White to off white, capsule shaped tablets, with a dimension of
approximately 17.1 mm in length and
9.1 mm in width, debossed with 'H' on one side and 'R9' on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paxlovid is indicated for the treatment of coronavirus disease 2019
(COVID-19) in adults who do not
require supplemental oxygen and who are at increased risk for
progressing to severe COVID-19 (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is 300 mg nirmatrelvir (two 150 mg tablets)
with 100 mg ritonavir
(one 100 mg tablet) all taken together orally every 12 hours for 5
days. Paxlovid should be
administered as soon as possible after a diagnosis of COVID-19 has
been made and within 5 days of
symptom onset. Completion of the full 5-day treatment course is
recommended even if the patient
requires hospitalisation due to severe or critical COVID-19 after
starting treatment with Paxlovid.
If the patient misses a dose of Paxlovid within 8 hours of the time it
is usually taken, the patient should
take it as soon a

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Paxlovid 150 mg + 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pink film-coated tablet contains 150 mg of nirmatrelvir.
Each white film-coated tablet contains 100 mg of ritonavir.
Excipients with known effect
Each pink 150 mg film-coated tablet of nirmatrelvir contains 176 mg of
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Nirmatrelvir
Film-coated tablet (tablet).
Pink, oval, with a dimension of approximately 17.6 mm in length and
8.6 mm in width debossed with
‘PFE’ on one side and ‘3CL’ on the other side.
Ritonavir
Film-coated tablet (tablet).
White to off white, capsule shaped tablets, with a dimension of
approximately 17.1 mm in length and
9.1 mm in width, debossed with 'H' on one side and 'R9' on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Paxlovid is indicated for the treatment of coronavirus disease 2019
(COVID-19) in adults who do not
require supplemental oxygen and who are at increased risk for
progressing to severe COVID-19 (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is 300 mg nirmatrelvir (two 150 mg tablets)
with 100 mg ritonavir
(one 100 mg tablet) all taken together orally every 12 hours for 5
days. Paxlovid should be
administered as soon as possible after a diagnosis of COVID-19 has
been made and within 5 days of
symptom onset. Completion of the full 5-day treatment course is
recommended even if the patient
requires hospitalisation due to severe or critical COVID-19 after
starting treatment with Paxlovid.
If the patient misses a dose of Paxlovid within 8 hours of the time it
is usually taken, the patient should
take it as soon a