Priligy Tablet, Film-coated 60 mg
देश: तंज़ानिया
भाषा: अंग्रेज़ी
स्रोत: Tanzania Medicinces & Medical Devices Authority
उत्पाद विशेषताएं
(SPC)
01-04-2022
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
Dapoxetine Hydrochloride
थमां उपलब्ध:
Berlin-Chemie AG, GERMANY
ए.टी.सी कोड:
Other urologicals incl. Antispasmodics
INN (इंटरनेशनल नाम):
Dapoxetine Hydrochloride
डोज़:
60 mg
फार्मास्यूटिकल फॉर्म:
Tablet, Film-coated
द्वारा बनाया गया:
Menarini - Von Heyden GmbH (M H), GERMANY
उत्पाद समीक्षा:
Physical description: Grey, circular, convex, film-coated tablets debossed with ''60'' inside a triangle on one side and black on the other side; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited (2404)
प्राधिकरण का दर्जा:
Registered/Compliant
प्राधिकरण की तारीख:
2021-03-29
उत्पाद विशेषताएं
TMDA/DMC/MRE/F/016
Version#1
TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY
PUBLIC ASSESSMENT REPORT FOR PRILIGY (DAPOXETINE HYDROCHLORIDE 60 MG)
FILM COATED TABLETS
VERSION NUMBER 1
MARCH, 2022
P. O. Box 77150, EPI Mabibo, Off Mandela Road, Dar es Salaam, Tanzania
Tel: +255-22-2450512/2450751/ 2452108; Fax: +255-22-2450793
Email: info@tmda.go.tz; Website: mwww.tmda.go.tz
1.
INTRODUCTION
Priligy is an innovator product containing the active substance
Dapoxetine hydrochloride.
Dapoxetine hydrochloride, belonging to a class of drugs known as
selective serotonin reuptake
inhibitors with ATC code G04BX14. Serotonin is thought to play a role
in ejaculatory reflex
mediation and is believed to act centrally and peripherally to inhibit
ejaculation, perhaps via the
serotonin (5HT)1a receptor.
The applicant has applied for the following indications: Priligy is
indicated for the treatment of
premature ejaculation (PE) in adult men aged 18 to 64 years.
The applied indications have been approved in Tanzania.
1.1 PRODUCT DETAILS
Registration number
TAN 21 HM 0116
Brand name
Priligy
Generic name, strength and form
Dapoxetine Hydrochloride 60 mg film coated tablets
ATC classification
G04BX14: Other urologicals
Distribution category
POM
Country of origin
Germany
Associated product
Priligy (Dapoxetine Hydrochloride 30 mg) film coated
tablets registered with registration number TAN 20 HM
0628
Marketing Authorization Holder
Berlin-Chemie AG (Menarmi Group),
Glienicker Weg 125, 12489, Berlin,
Germany.
E-Mail: prijli@menarini.it
Local Technical Representative
Phillips Pharmaceuticals (Tanzania) Ltd,
Vingunguti Industriai Area, Nyerere Road,
P.O. Box 737,
Dar Es Saalam, Tanzania.
E-Mail: kunal.assar@phillipstanzania.co
1.2 ASSESSMENT PROCEDURE
The application for registration of Priligy was submitted on 12
October, 2018. The product
underwent abridged assessment. Assessment was completed in 3 (three)
rounds of evaluation.
Priligy was registered on <29/03/2021 >
1.3 INFORMATION FOR USERS
Visual description of the finished product
Grey
पूरा दस्तावेज़ पढ़ें
