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Marketing Authorisation Holder

Mylan Laboratories Limited

INDIA

GMP Certified

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

Bengaluru, India

Maps

411

Total Medicines

293

Active

8

Dosage Forms

8

Countries

Tanzania (87) Zimbabwe (84) Botswana (56) Kenya (44) Uganda (43) Zambia (41) Ghana (30) Rwanda (26)

Location

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

Registration Status

Registered 293
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) 67
Valid 17
PRESCRIPTION PREPARATIONS 10TH SCHEDULE, (P.P.10) 15
3 months to expiry 13
Unknown 3
PHARMACIST INITIATED MEDICINES, (P.I.M.) 2
Retained 1

Therapeutic Classes

GENERIC/BIOSIMILARS 33
NEW/INNOVATOR 7

Local Agents / Applicants

MYLAN LABORATORIES LIMITED 149
Mylan Laboratories Limited 124
MYLAN LABORATORIES LIMITED... 55
MYLAN LABORATORIES LIMITED [OTL] 15
Worldwide Healthcare... 13
Worldwide Healthcare... 9

Registered Medicines

Showing 20 of 411 · Page 16 of 21

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Product Country Status

OTYCULF

Dehydrated Alcohol q.s q.s,Flucytosine 500 mg/6 mL,Magnesium Stearate (Hyqual VG) 7 mg/6 mL,Maize starch 50 mg/6 mL,Microcrystalline cellulose ( Avicel PH 102 ) 73 mg/6 mL,Partially pregelatinized maize starch (starch 1500) 30 mg/6 mL,Povidone (PVP) K-30 15 mg/6 mL,Syloid 244 FP (Silicon dioxide) 25 mg/6 mL

Tanzania Registered/Compliant

OTYCULF 250

Dehydrated Alcohol q.s q.s,Dehydrated alcohol (ethanol absolute 99.9%) q.s q.s,Flucytosine 250 mg/6 mL,Magnesium Stearate (Hyqual VG) 3.5 mg/6 mL,Maize starch 25 mg/6 mL,Microcrystalline cellulose ( Avicel PH 102 ) 36.5 mg/6 mL,Partially pregelatinized maize starch (starch 1500) 15 mg/6 mL,Povidone (PVP) K-30 7.5 mg/6 mL,Syloid 244 FP (Silicon dioxide) 12.5 mg/6 mL

Tanzania Registered/Compliant

OTYCULF 250

FLUCYTOSINE

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

OTYCULF 250

FLUCYTOSINE PH. EUR.

Kenya Registered

OTYCULF 500

FLUCYTOSINE

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

OTYCULF 500

FLUCYTOSINE PH. EUR.

Kenya Registered

Ondansetron Tablets USP 4 mg

Ondansetron Hydrochloride Dihydrate Ph.Eur.

Kenya

Ondansetron Tablets USP 8 mg

Ondansetron Hydrochloride Dihydrate Ph.Eur.

Kenya

Oralcon F

Acacia 1.77 mg,Disodium Edetate 0.00585 mg,Ethinylestradiol 0.03 mg,Ethyl cellulose 0.325 mg,Ferrous Fumarate 75 mg,Isopropyl Alcohol - ml,Lactose 58.32 mg,Levonorgestrel 0.15 mg,Magnesium Stearate 0.50 mg,Microcrystalline cellulose 0.22 mg,Polacrilin Potassium 1 mg,Polyethylene Glycol 6000 0.268 mg,Purified Talc. 10.53 mg,Purified Water - ml,Sucrose 15.61 mg,Titanium dioxide 0.280 mg

Zambia Registered/Compliant

Oralcon-F tablets

Ethinylestradiol 0.03 mg,Ferrous Fumarate 75 mg,Levonorgestrel 0.15 mg

Zambia Registered/Compliant

P2

Levonorgestrel 0.75 mg

Tanzania Registered/Compliant

PACLITAXEL MYLAN

PACLITAXEL

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

PACLITAXEL MYLAN

PACLITAXEL

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

PACLITAXEL MYLAN

PACLITAXEL

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

PREGABALIN + NORTRIPTYLINE (AS HYDROCHLORIDE)

-

Uganda Registered

PREGNON

Levonorgestrel 0.75 mg

Zambia Registered/Compliant

PRETOMANID

-

Uganda Registered

Pregnon tablets

Levonorgestrel

Zambia Registered/Compliant

REVOKE -72

Levonorgestrel

Rwanda Registered

RICOVIR

TENOFOVIR DISOPROXIL FUMARATE

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