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Marketing Authorisation Holder

Mylan Laboratories

India

GMP Certified

Prestige Tech Park,Platina-3, PRESTIGE TECH PARK, 7th to 12th, Kadubeesanahalli, Bengaluru, Bellandur Amanikere, Karnataka 560103, India

Bengaluru, India

Maps

376

Total Medicines

265

Active

8

Dosage Forms

7

Countries

Botswana (98) Tanzania (76) Zimbabwe (71) Zambia (40) Ghana (37) Kenya (28) Rwanda (26)

Location

Prestige Tech Park,Platina-3, PRESTIGE TECH PARK, 7th to 12th, Kadubeesanahalli, Bengaluru, Bellandur Amanikere, Karnataka 560103, India

Registration Status

Registered 265
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 56
Valid 24
3 months to expiry 13
PRESCRIPTION PREPARATIONS 10TH SCHEDULE, (P.P.10) 12
Unknown 3
PHARMACIST INITIATED MEDICINES, (P.I.M.) 3

Therapeutic Classes

NEW/INNOVATOR 1

Local Agents / Applicants

Mylan Laboratories Limited 102
MYLAN LABORATORIES LIMITED... 90
MYLAN LABORATORIES LIMITED 49
MYLAN LABORATORIES LIMITED [OTL] 18
Worldwide Healthcare... 13
Worldwide Healthcare... 9

Registered Medicines

Showing 20 of 376 · Page 7 of 19

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Product Country Status

ENVUTEG

Dolutegravir Sodium 50 mg

Botswana Registered/Compliant

ENVUTEG

DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR ALAFENAMIDE

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

EPANUTIN

PHENYTOIN

Kenya Registered

EPANUTIN

PHENYTOIN SODIUM

Kenya Registered

EPANUTIN INJECTION

PHENYTOIN SODIUM

Kenya Registered

ERESTZ

EMTRICITABINE, RILPIVIRINE, TENOFOVIR DISOPROXIL FUMARATE 200mg/35mg/300mg

Botswana Registered/Compliant

ERESTZ

EMTRICITABINE, RILPIVIRINE, TENOFOVIR DISOPROXIL FUMARATE 200/35/300MG

Botswana Registered/Compliant

ESTIVA

-

Botswana Registered/Compliant

Emtricitabine + Tenofovir alafenamide fumarate

Emtricitabine 200 mg,Tenofovir Alafenamide Fumarate 25 mg

Tanzania Registered/Compliant

Emtricitabine and Tenofovir Alafenamide Tablets 200 mg/25 mg

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Rwanda Registered

Envuteg

Croscarmellose Sodium(AC-DI-SOL) 40 mg,Croscarmellose Sodium(AC-DI-SOL) 50 mg,Dolutegravir Sodium 52.6 mg,Lactose Monohydrate (Flowlac 100) 60 mg,Lamivudine 300 mg,Magnesium Stearate (Hyqual VG) 1 mg,Magnesium Stearate (Hyqual VG) 14 mg,Mannitol (pearlitol 25C) 131.4 mg,Microcrystalline Cellulose ( Avicel PH 112 ) 64 mg,Microcrystalline Cellulose (Avicel PH 101) 60 mg,Microcrystalline Cellulose (Ceolus UF 702) 118.96 mg,Opadry II White 30 mg,Povidone (K-30) 15 mg,Purified Water qs ml,Sodium starch glycolate (Premajole) 15 mg,Tenofovir Alafenamide Fumarate 28.04 mg

Zambia Registered/Compliant

Envuteg Tablets

Dolutegravir Sodium 52.6 mg,Lamivudine 300 mg,Tenofovir Alafenamide Fumarate 28.04 mg

Zambia Registered/Compliant

FAMILIA

-

Botswana Registered/Compliant

FAMILIA

ETHINYL ESTRADIOL; FERROUS FUMARATE; LEVONORGESTREL

Zimbabwe PRESCRIPTION PREPARATIONS 10TH SCHEDULE, (P.P.10)

FAMYTEC

Misoprostol (1% HPMC dispersion) 200 mcg

Zambia Registered/Compliant

FAMYTEC

-

Botswana Registered/Compliant

FAMYTEC

-

Botswana Registered/Compliant

FAMYTEC

-

Botswana Registered/Compliant

FAMYTEC

-

Botswana Registered/Compliant

FAMYTEC

-

Botswana Registered/Compliant