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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 9 of 19

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Product Country Status

ISONIAZID

-

Botswana Registered/Compliant

ISONIAZID

-

Botswana Registered/Compliant

ISONIAZID

-

Botswana Registered/Compliant

Isoniazid

Isoniazid 300mg

Zambia Registered/Compliant

Isoniazid Tablet BP

Isoniazid 100 mg/0.8 ML

Tanzania Registered/Compliant

Isoniazid Tablets BP 300 mg

Cellulose Microcrystalline 30.000 mg/6 mL,Croscarmellose Sodium 6.000 mg/6 mL,Isoniazid 300 mg,Mannitol 207.000 mg/6 mL,Povidone K30 15.000 mg/6 mL,Purified Water q.s q.s,Silica colloidal anhydrous Ph. Eur 3.000 mg/6 mL,Starch Pregelatinised 30.000 mg/6 mL,Stearic Acid 9.000 mg/6 mL

Tanzania Registered/Compliant

Isoniazid/Pyridoxine Hydrochloride/ Sulfamethoxazole/Trimethoprim tablets 300 mg/25 mg/800 mg/160 mg

Colloidal silicon dioxide (Aerosil 200 pharma) 3.300 mg/6 mL,Docusate sodium 1.500 mg/6 mL,Hydroxy Propyl Cellulose 1.500 mg/6 mL,Hydroxy Propyl cellulose (Klucel LF) 27.000 mg/6 mL,Isoniazid 300 mg/6 mL,Low-substituted Hydroxy Propyl Cellulose 36.400 mg/6 mL,Magnesium Stearate 7.500 mg/6 mL,Microcrystalline Cellulose (Avicel PH101 32.60 mg/6 mL,Microcrystalline cellulose 41.900 mg/6 mL,Opadry Brown 03F86918 31.000 mg/6 mL,Partially pregelatinized maize starch (starch 1500) 24.850 mg/6 mL,Purified Water q.s q.s,Pyridoxine Hydrochloride 25 mg/6 mL,Sodium starch glycolate (Premajole) 11.200 mg/6 mL,Sodium starch glycolate (Premajole) 16.000 mg/6 mL,Stearic Acid 3.800 mg/6 mL,Sulfamethoxazole 800 mg/6 mL,Trimethoprim 160 mg/6 mL

Tanzania Registered/Compliant

Isoniazid/Pyridoxine hydrochloride/…

Isoniazid Ph.Eur, Pyridoxine HCl Ph.Eur, …

Kenya

KAVIDEZA

ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE

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

KAVIDEZA DISTAB

Abacavir, Dolutegravir and Lamivudine Dispersible Tablets 60 mg / 5 mg/ 30 mg

Rwanda Registered

KAVIDEZA DISTAB

Abacavir sulfate equivalent to Abacavir 60 mg/6 mL,Acesulfame potassium 12.000 mg/6 mL,Colloidal Silicon Dioxide (Aerosil 200 pharma) (Part-I) 2.000 mg/6 mL,Colloidal Silicon Dioxide (Aerosil) 4.000 mg/6 mL,Crospovidone(Polyplasdone XL) 14.000 mg/6 mL,Crospovidone(Polyplasdone XL) 7.200 mg/6 mL,Dolutegravir Sodium equivalent to Dolutegravir 5 mg,Iron oxide red (Sicovit Red 30 El72) 0.125 mg/6 mL,Lamivudine 30 mg,Mannitol (Pearlitol 25 C) USP-NF/Ph.Eur 14.540 mg/6 mL,Microcrystalline Cellulose (Avicel PH101) 6.000 mg/6 mL,Opadry pink 85F540521 15.200 mg/6 mL,Povidone (Plasdone K 29/32) USP-NF/ Ph. Eur. 1.500 mg/6 mL,Purified water.. q.s q.s,Silicified microcrystalline celluloase 50.000 mg/6 mL,Silicified microcrystalline cellulose (Prosolv SMCC 50) (Part-II) 103.797 mg/6 mL,Silicified microcrystalline cellulose (Prosolv SMCC 50) (Part-II) 34.400 mg/6 mL,Sodium Starch Glycolate (Type A: pH 5.5-7.5) 1.500 mg/6 mL,Sodium Stearyl Fumarate (PRUV) (Part-I) 1.600 mg/6 mL,Sodium Stearyl Fumarate (PRUV) (Part-III) 4.

Tanzania Registered/Compliant

KAVIDEZA DISTAB

Dolutegravir Sodium 5mg

Botswana Registered/Compliant

KAVIDEZA DISTAB

Dolutegravir Sodium 5mg

Botswana Registered/Compliant

KAVIDEZA DISTAB

ABACAVIR SULPHATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE

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

KAVIDEZA DISTAB TABLETS (Each dispersible tablet contains Abacavir Sulfate/Dolutegravir Sodium/Lamivudine 60mg/5mg/30mg)

Abacavir Sulfate/Dolutegravir Sodium/Lamivudine

Ghana Valid

KOCITAF

Dolutegravir Sodium 50 mg,Emtricitabine 200 mg,Tenofovir Alafenamide Fumarate 25 mg

Tanzania Registered/Compliant

KOCITAF

Dolutegravir Sodium, Emtricitabine and Tenofovir Alafenamide Fumarate 50mg/200mg/25mg

Botswana Registered/Compliant

KOCITAF

Dolutegravir Sodium, Emtricitabine and Tenofovir Alafenamide Fumarate 50mg/200mg/25mg

Botswana Registered/Compliant

KOCITAF

-

Botswana Registered/Compliant

KOCITAF

DOLUTEGRAVIR EMTRICITABINE TENOFOVIR ALAFENAMIDE

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