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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 14 of 19

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Product Country Status

MyHep DVIR

Daclatasvir Dihydrochloride equivalent to daclatasvir 60 mg,sofosbuvir 400 mg

Tanzania Registered/Compliant

MyHep DVIR Tablets (Daclatasvir 60mg + Sofosbuvir 400mg)

Daclatasvir Dihydrochloride equivalent to daclatasvir 66.00 mg,sofosbuvir 400 mg

Zambia Registered/Compliant

Mydekla 60 Tablets

Daclatasvir Dihydrochloride equivalent to daclatasvir 66.00 mg

Zambia Registered/Compliant

Myhep

sofosbuvir 400 mg

Tanzania Registered/Compliant

Mytrex Injection

Pemetrexed Powder for Infusion

Zambia Registered/Compliant

NEURONTIN

GABAPENTIN

Kenya Registered

NEURONTIN

GABAPENTIN

Kenya Registered

NORVASC

AMLODEPINE BESYLATE

Kenya Registered

NORVASC

AMLODEPINE BESYLATE

Kenya Registered

OSELTAMIVIR PHOSPHATE

oseltamivir

Botswana Registered/Compliant

OSELTAMIVIR PHOSPHATE

-

Botswana Registered/Compliant

OSELTAMIVIR PHOSPHATE 75MG

-

Botswana Registered/Compliant

OSELTAMIVIR PHOSPHATE 75MG

-

Botswana Registered/Compliant

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 500

FLUCYTOSINE

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

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