SPRAVATO NASAL SPRAY

Pays: Afrique du Sud

Langue: anglais

Source: South African Health Products Regulatory Authority (SAHPRA)

Disponible depuis:

Janssen Pharmaceutica (Pty) Ltd

Dosage:

Not Indicated

forme pharmaceutique:

NASAL SPRAY

Composition:

None

Statut de autorisation:

Registered

Notice patient

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
SPRAVATO NASAL SPRAY
PROPOSED CLEAN AMENDED PATIENT INFORMATION LEAFLET
Submission date:
22 JUNE 2021
Reference number:
RA/2021/06/209/MK
Submission type:
NEW CHEMICAL ENTITY (NCE) APPLICATION FOR REGISTRATION (ECTD):
COMPLIANT RESPONSE TO
2ND CLINICAL EVALUATION QUERIES
______________________________________________________________________________________
CCDS Aug 2018, Sep 2018, Jul 2019
Page 1 of 14
_ _
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
SPRAVATO
® Nasal Spray
contains 28 mg esketamine as hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN SPRAVATO
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse or
other health care provider
-
SPRAVATO has been prescribed for you personally and you should not
share
your medicine with other people. It may harm them, even if their
symptoms
are the same as yours.
WHAT IS IN THIS LEAFLET
1.
What SPRAVATO is and what it is used for
2.
What you need to know before you use SPRAVATO
3.
How to use SPRAVATO
4.
Possible side effects
5.
How to store SPRAVATO
6.
Contents of the pack and other information
Schedule 5
06 April 2022
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
SPRAVATO NASAL SPRAY
PROPOSED CLEAN AMENDED PATIENT INFORMATION LEAFLET
Submission date:
22 JUNE 2021
Reference number:
RA/2021/06/209/MK
Submission type:
NEW CHEMICAL ENTITY (NCE) APPLICATION FOR REGISTRATION (ECTD):
COMPLIANT RESPONSE TO
2ND CLINICAL EVALUATION QUERIES
______________________________________________________________________________________
CCDS Aug 2018, Sep 2018, Jul 2019
Page 2 of 14
_ _
1.
WHAT SPRAVATO IS AND WHAT IT IS USED FOR
WHAT SPRAVATO IS
SPRAVATO contains the active substance esketamine. This belongs to a
group of
medicines called anti-depressants and you have been given this
medicine to treat
your depression.
WHAT SPRAVATO IS USED FOR
SPRAVATO is a nasal spray used in adults to reduce the sympt

Résumé des caractéristiques du produit

Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
SPRAVATO NASAL SPRAY
PROPOSED CLEAN AMENDED PROFESSIONAL INFORMATION
Submission date:
22 JUNE 2021
Reference number:
RA/2021/06/209/MK
Submission type:
NEW CHEMICAL ENTITY (NCE) APPLICATION FOR REGISTRATION (ECTD):
COMPLIANT RESPONSE TO
2
ND CLINICAL EVALUATION QUERIES
______________________________________________________________________________________
CCDS Aug 2018, CCDS Sep 2018, Jul 2019
Page 1 of 38
_ _
PROFESSIONAL INFORMATION
SCHEDULING STATUS
1.
NAME OF THE MEDICINE
SPRAVATO
®
Nasal Spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each nasal spray device contains esketamine hydrochloride
corresponding to 28 mg
esketamine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution.
Clear, colourless, aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SPRAVATO is indicated, in conjunction with an oral antidepressant
(SSRI or SNRI), for
the treatment of treatment-resistant depression (TRD) in adult
patients who have not
responded adequately to treatment with at least two different
antidepressants of
adequate dose and duration to treat the current depressive episode.
Schedule 5
06 April 2022
Applicant: JANSSEN PHARMACEUTICA (PTY) LTD
Product Proprietary Name:
SPRAVATO NASAL SPRAY
PROPOSED CLEAN AMENDED PROFESSIONAL INFORMATION
Submission date:
22 JUNE 2021
Reference number:
RA/2021/06/209/MK
Submission type:
NEW CHEMICAL ENTITY (NCE) APPLICATION FOR REGISTRATION (ECTD):
COMPLIANT RESPONSE TO
2
ND CLINICAL EVALUATION QUERIES
______________________________________________________________________________________
CCDS Aug 2018, CCDS Sep 2018, Jul 2019
Page 2 of 38
_ _
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
SPRAVATO should be administered in conjunction with an oral
antidepressant (AD).
A treatment session consists of nasal administration of SPRAVATO and
post-
administration observation under the supervision of a healthcare
professional.
SPRAVATO is for nasal use only. The nasal spray d