Marketing Authorisation Holder

Johnson & Johnson Middle East FZ LLC

FOREIGN

Building 14, Level 7 - 26 United Arab Emirates - Umm Hurair Second - Dubai Healthcare City - Dubai - United Arab Emirates

Dubai, United Arab Emirates

Maps

Total Medicines

Active

Dosage Forms

Country

Kenya (53)

Location

Building 14, Level 7 - 26 United Arab Emirates - Umm Hurair Second - Dubai Healthcare City - Dubai - United Arab Emirates

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Registration Status

Registered 42

Retained 6

Unknown 4

Withdrawn 1

Dosage Forms

Tablet 4 25 MG 3 MICONAZOLE NITRATE 20 MG/G 2 EACH PRE FILLED SYRINGE CONTAINS 234 MG PALIPERIDONE PALMITATE EQUIVALENT TO 150 MG PALIPERIDONE 2 50 MG 2 20MG 2 20 MG/G 2 2 MG 2

Therapeutic Classes

NEW/INNOVATOR 30

Local Agents / Applicants

JANSSEN-CILAG INTERNATIONAL NV 10

JOHNSON & JOHNSON MIDDLE... 6

JANSSEN PHARMACEUTICA (PTY) LTD 6

JANSSEN CILAG INTERNATIONAL NV 5

JANSSEN-CILAG NV 2

JANSSEN CILAG AG 2

Distributing Wholesalers

Licensed wholesalers / distributors that carry this MAH's brands.

Eastleigh Pharmaceutical

Eastleigh, Nairobi

8 SKUs

Generics Africa

Nairobi

5 SKUs

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Registered Medicines

Showing 20 of 53 · Page 1 of 3

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Product	Form / Strength	Country	Reg. Number	Status
CONCERTA 18MG METHYLPHENIDATE HYDROCHLORIDE	18MG	Kenya	H2016/CTD 2473/273	Registered
CONCERTA 27MG METHYLPHENIDATE HYDROCHLORIDE	27MG	Kenya	H2016/CTD 2475/276	Registered
CONCERTA 36MG METHYLPHENIDATE	36MG	Kenya	H2016/CTD 2476/275	Registered
CONCERTA 36MG methylphenidate	Tablet	Kenya	H2016/CTD2476/275/R1	Retained
CONCERTA 54MG METHYLPHENIDATE HYDROCHLORIDE	54MG	Kenya	H2016/CTD 2474/274
COVID-19 VACCINE JANSSEN (AD26.COV2-S [RECOMBINANT]) COVID-19 VACCINE (AD26.COV2-S [RECOMBINANT])	ONE DOSE (0.5 ML) CONTAINS: ADENOVIRUS TYPE 26 ENCODING THE SARS-COV-2 SPIKE GLYCOPROTEIN* (AD26.COV2-S), NOT LESS THAN 2.5 × 1010 VIRUS PARTICLES OF AD26.COV2-S OR NOT LESS THAN 8.92 LOG10 INFECTIOUS UNITS (INF.U).	Kenya	H2021/CTD8692/20203EUA	Revoked
Concerta 27mg extended-release tablet Methylphenidate Hydrochloride	Tablet	Kenya	H2016/CTD 2475/276/R1	Retained
Concerta 27mg extended-release tablet Methylphenidate Hydrochloride	Tablet	Kenya	H2016/CTD2475/276/R1	Retained
Concerta 36mg extended-release tablet methylphenidate hydrochloride	Tablet	Kenya	H2016/CTD 2476/275/R1	Retained
DAKTACORT CREAM MICONAZOLE NITRATE AND HYDROCORTISONE	MICONAZOLE NITRATE 20 MG/G AND HYDROCORTISONE 10 MG/G	Kenya	818	Registered
DAKTARIN CREAM MICONAZOLE NITRATE	MICONAZOLE NITRATE 20 MG/G	Kenya	817	Registered
DAKTARIN ORAL GEL MICONAZOLE NITRATE	MICONAZOLE NITRATE 20 MG/G	Kenya	3555	Registered
DUROGESIC 25MCG FENTANYL	4.2 MG FENTANYL/PATCH	Kenya	H2013/21132/145	Registered
DUROGESIC 50MCG FENTANYL	8.4 MG FENTANYL/PATCH	Kenya	H2011/21133/277	Registered
ERLEADA TABLET APALUTAMIDE	60MG	Kenya	H2026/CTD11742/24074	Registered
GYNO-DAKTARIN VC MICONAZOLE NITRATE	20 MG/G	Kenya	816	Registered
GYNO DAKTARIN 400 MG MICONAZOLE NITRATE	400 MG	Kenya	3554	Registered
IMODIUM CAPSULES LOPERAMIDE HYDROCHLORIDE	EACH CAPSULE CONTAINS 2 MG LOPERAMIDE HYDROCHLORIDE.	Kenya	811	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

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53 products