Janssen-Cilag International NV

FOREIGN

Lammerdries-Oost 55, 2250 Olen, Belgium

Olen, Belgium

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Total Medicines

Active

Dosage Forms

Countries

Kenya (20) Rwanda (3) Uganda (2) Zimbabwe (1) Tanzania (1) Ghana (1)

Location

Lammerdries-Oost 55, 2250 Olen, Belgium

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Registration Status

Registered 19

Unknown 3

Retained 3

3 months to expiry 1

PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 1

Withdrawn 1

Dosage Forms

Film-Coated Tablet 3 Prolonged-release suspension for injection 2 ORAL SOLID ORDINARY FILM-COATED TABLETS 2 gel 1 VOKANAMET 150MG/1000MG (CANAGLIFLOZIN/METFORMIN) 1 Tablets 1 TABLETS 1 TABLET; ORAL 1

Therapeutic Classes

NEW/INNOVATOR 16

Local Agents / Applicants

JANSSEN-CILAG INTERNATIONAL NV 22

PHILLIPS THERAPEUTICS LIMITED 3

Janssen-Cilag International NV 1

Ernest Chemist Limited -... 1

Registered Medicines

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Product	Form / Strength	Country	Reg. Number	Status
BEDAQUILINE FUMARATE -	ORAL SOLID ORDINARY FILM-COATED TABLETS 100MG	Uganda	NDA/MAL/HDP/7715	Registered
DAKTARIN ORAL GEL MICONAZOLE NITRATE	gel 2% w/w	Ghana	FDA/SD.233-070767	3 months to expiry
EPREX PROTECS 10000U EPOETIN ALFA	10000	Kenya	H93/312	Registered
INTELENCE 25 MG ETRAVIRINE	25 MG ETRAVIRINE PER TABLET	Kenya	H2015/CTD3938/468	Withdrawn Voluntarily by MAH
INTELENCE-100 INTRAVIRINE	TABLETS 100MG	Rwanda	Rwanda FDA-HMP-MA-1947	Registered
INVEGA SUSTENNA PALIPERIDONE PALMITATE	EACH PRE FILLED SYRINGE CONTAINS 156 MG PALIPERIDONE PALMITATE EQUIVALENT TO 100MG PALIPERIDONE	Kenya	H2019/4435/150ER	Registered
INVEGA SUSTENNA 117 PALIPERIDONE PALMITATE	EACH PRE FILLED SYRINGE CONTAINS 117MG PALIPERIDONE PALMITATE EQUIVALENT TO 75 MG PALIPERIDONE.	Kenya	H2019/4434/152ER	Registered
INVEGA SUSTENNA 78 PALIPERIDONE PALMITATE	EACH PRE FILLED SYRINGE CONTAINS 78 MG PALIPERIDONE PALMITATE EQUIVALENT TO 50 MG PALIPERIDONE	Kenya	H2019/4433/151ER
INVEGA® 9 MG PROLONGED-RELEASE TABLETS PALIPERIDONE	EACH PROLONGED-RELEASE TABLET CONTAINS 9 MG OF PALIPERIDONE	Kenya	H2018/4832/173ER	Registered
INVOKANA 100MG CANAGLIFLOZIN	100MG	Kenya	CTD 4713	Registered
INVOKANA 300MG CANAGLIFLOZIN	300MG	Kenya	4714	Registered
PREZISTA 150 mg Darunavir	Film-Coated Tablet	Kenya	H2015/CTD2306/305/R1	Retained
PREZISTA 400 MG DARUNAVIR	400 MG DARUNAVIR CORRESPONDING TO 433.64 MG OF DARUNAVIR ETHANOLATE	Kenya	H2016/CTD3706/633
PREZISTA 600mg Darunavir	Film-Coated Tablet	Kenya	H2012/CTD159/443/R1	Retained
PREZISTA 75 mg Darunavir	Film-Coated Tablet	Kenya	H2015/CTD2305/304/R1	Retained
Paliperidone Palmitate 1000mg Paliperidone Palmitate 1000mg	Prolonged-release suspension for injection 1000mg	Rwanda	Rwanda FDA-HMP-MA-0827	Registered
Paliperidone Palmitate 700mg Paliperidone Palmitate 700mg	Prolonged-release suspension for injection 700mg	Rwanda	Rwanda FDA-HMP-MA-0826	Registered
RILPIVIRINE -	ORAL SOLID ORDINARY FILM-COATED TABLETS 25MG	Uganda	NDA/MAL/HDP/6257	Registered
SIRTURO BEDAQUILINE	TABLET; ORAL 100MG	Zimbabwe	2021/7.3/6156	PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
Sirturo Bedaquiline Fumarate equivalent to Bedaquiline 100 mg	Tablets 100	Tanzania	TZ 17 H 0239	Registered/Compliant

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28 products