This is to inform the General Public that the following products are approved for withdrawal, suspension and cancellation by NAFDAC. They are therefore no longer permitted for manufacture, importation, exportation, distribution, advertisement, sale and use within Nigeria. Please note that: 1. The Certificate of Registration of a product is said to be withdrawn when the use of the Certificate of Registration of that product is discontinued upon request of the Market Authorization Holder. 2. The Certificate of Registration of a product may be suspended when the conditions upon which the NAFDAC Registration license was issued are no longer met and the Agency is to make a determination. 3. The Certificate of Registration of a product is said to be cancelled when the NAFDAC Certificate of Registration license of that product is revoked by NAFDAC. |
| S/N | Product name | Dosage form | NAFDAC Number | Active Ingredient | Market Authorization Holder | Application Purpose |
|---|---|---|---|---|---|---|
| 1 | Abacavir Sulfate/Lamivudine Dispersible Tablets 60mg/30mg Tablets | Tablets | C4-1180 | Abacavir sulfate and Lamivudine | Healthline Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 2 | Amaryl M Tablets | Tablets | A4-2619 | Glimepiride + Metformin Hydrochloride | Sanofi Aventis Nigeria ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 3 | Amaryl M SR Tablets | Tablets | A4-7296 | Glimepiride + Metformin Hydrochloride | Sanofi Aventis Nigeria ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 4 | Aprovasc 150mg/5mg tablets | Tablets | B4-2687 | Amlodipine Besylate+Aprovasc | Sanofi Aventis Nigeria ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 5 | Artemether/Lumefantrine 40mg/240mg Tablets | Tablets | B4-5745 | Artemether/Lumefantrine 40mg/240mg | Healthline Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 6 | ASAQ(Artesunate amodiaquine Winthrop) 100mg/270mg Tablets | Tablets | A4-3357 | Artesunate Amodiaquine Winthrop 100mg/270mg | Sanofi Aventis Nigeria ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 7 | ASAQ(Artesunate amodiaquine Winthrop) 25mg/67.5mg Tablets | Tablets | A4-3406 | Artesunate Amodiaquine Winthrop 25mg/67.5mg | Sanofi Aventis Nigeria ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 8 | ASAQ(Artesunate amodiaquine Winthrop) 50mg/135mg Tablets | Tablets | A4-3405 | Artesunate Amodiaquine Winthrop 50mg/135mg | Sanofi Aventis Nigeria ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 9 | Betopic Eye drop | Eye Drop | 04 2404 | Batexolol Hydrochloride | Novartis Nigeria Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 10 | Coaprovel 300mg/25mg Tablets | Tablets | B4-2317 | Hydrochlorothiazize+Irbesartan | Sanofi Aventis Nigeria ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 11 | Combination 3 Tablets | Tablet | A4-6459 | Estrogen, Progestin | Bayer East Africa Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 12 | Efavirenz 600mg Tablets | Tablets | A4-1318 | Efavirenz 600mg | Healthline Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 13 | Elisca eye drop | Eye Drop | 04 2461 | Chloramphenicol Eye Drop | Sanofi Aventis Nigeria ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 14 | Flagyl Suspension | Suspension | A4-3947 | Metronidaxole Benzoate | Sanofi Aventis Nigeria ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 15 | Flagyl Tablet 400mg | Tablets | 04 5566 | Metronidaxole | Sanofi Aventis Nigeria ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 16 | Iliadin Adult 0.05% Metered Nose Spray | Spray | B4-9913 | Oxymetazoline HCl 0.05%M/V | Fensyl MHP Consulting Ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 17 | Iliadin baby 0.01% nose drops | Spray | C4-0106 | Oxymetazoline HCl 0.01%M/V | Fensyl MHP Consulting Ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 18 | Iliadin kids 0.025% nose drops | Spray | B4-9912 | Oxymetazoline HCl 0.025%M/V | Fensyl MHP Consulting Ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 19 | Invanz 1g Injections | Injectables | 04 8118 | Ertapenem 1g | MSD Idea Pharmaceuticals Nigeria LTD | Withdrawn Voluntarily by Market Authorization Holder |
| 20 | Invega (Paliperidone) 3mg extended release tablets | Tablets | B4-8223 | Paliperidone | Janssen Pharmaceutical Companies | Withdrawn Voluntarily by Market Authorization Holder |
| 21 | Invega (Paliperidone) 6mg extended release tablets | Tablets | B4-8222 | Paliperidone | Janssen Pharmaceutical Companies | Withdrawn Voluntarily by Market Authorization Holder |
| 22 | Invega(Paliperidone) 9mg extended release tablets | Tablets | B4-8221 | Paliperidone | Janssen Pharmaceutical Companies | Withdrawn Voluntarily by Market Authorization Holder |
| 23 | Janumet 50mg/1000mg Tablets | Tablets | B4-1771 | Sitagliptin 50mg, Metformin Hydrochloride 1000mg | MSD Idea Pharmaceuticals Nigeria LTD | Withdrawn Voluntarily by Market Authorization Holder |
| 24 | Janumet 50mg/850mg Tablets | Tablets | B4-1637 | Sitagliptin 50mg, Metformin Hydrochloride 850mg | MSD Idea Pharmaceuticals Nigeria LTD | Withdrawn Voluntarily by Market Authorization Holder |
| 25 | Januvia 100mg Tablets | Tablets | B4-0023 | Sitagliptin 100mg | MSD Idea Pharmaceuticals Nigeria LTD | Withdrawn Voluntarily by Market Authorization Holder |
| 26 | Januvia 50mg Tablets | Tablets | B4-0335 | Sitagliptin 50mg | MSD Idea Pharmaceuticals Nigeria LTD | Withdrawn Voluntarily by Market Authorization Holder |
| 27 | Kombiglyze 2.5mg/1000mg tablets | Tablets | A4-9646 | Saxagliptin , Metformin Hcl | AstraZeneca Nigeria Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 28 | Kombiglyze 5mg/1000mg tablets | Tablets | A4-9645 | Saxagliptin ,metformin Hcl | AstraZeneca Nigeria Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 29 | Lamivudine/Nevirapine/Zidovudine Dispersible Tablets 150mg/200mg/300mg | Tablets | A4-2813 | Lamivudine/Nevirapine/Zidovudine Dispersible Tablets 150mg/200mg/300mg | Healthline Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 30 | Lamivudine/Nevirapine/Zidovudine Dispersible Tablets 30mg/50mg/60mg | Tablets | A4-1319 | Lamivudine/Nevirapine/Zidovudine Dispersible Tablets 30mg/50mg/60mg | Healthline Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 31 | Lexotan 3mg Tablets | Tablets | 04 8808 | Bromazepam | F. Hoffmann-La Roche Ltd. Basel, Switzerland. | Withdrawn Voluntarily by Market Authorization Holder |
| 32 | Mosegor Syrup | Syrup | 04 8106 | Pizotifen 0.05mg/ml | Novartis Nigeria Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 33 | Nevirapine Tablets 200mg | Tablets | A4-1431 | Nevirapine 200mg | Healthline Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 34 | Onglyza 2.5mg tablets | Tablets | A4-8864 | Saxagliptin | AstraZeneca Nigeria Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 35 | Onglyza 5mg tablets | Tablets | A4-8863 | Saxagliptin | AstraZeneca Nigeria Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 36 | Penicillin G Sodium Sandoz Powder for Solution for Injection | Injectables | B4-6367 | Benzylpenicillin 1000000IU | Novartis Nigeria Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 37 | Salbutamol 100mcg Inhaler | Inhaler | B4-8493 | Salbutamol 100mcg | Novartis Nigeria Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 38 | Sporanox (Itraconazole) 100mg capsule | Capsule | 04 2404 | Itraconazole 100mg | Worldwide Healthcare Ventures Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 39 | Xyzal Oral Drops | Drops | B4-9691 | Levocetrizine Dihydrochloride | GlaxoSmithKline Pharmaceutical Nigeria Ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 40 | Zidovudine 300mg Tablets | Tablets | A4-1314 | Zidovudine 300mg | Healthline Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 41 | Uptivite Man | Tablets | A7-101014L | Supplement | Gentlehills Limited | Cancelled by NAFDAC |
| 42 | Mist Alba Suspension | Suspension | A11-0871 | Magnesium Sulphate | Gentlehills Limited | Cancelled by NAFDAC |
| 43 | Gentle Hill Cough Syrup | Syrup | A11-0872 | Diphenhydramine HCl, Ammonium Chloride, Menthol ,Sodium Citrate | Gentlehills Limited | Cancelled by NAFDAC |
| 44 | Gentlehills Vitamin C Syrup | Syrup | A11-0936 | Ascobic Acid | Gentlehills Limited | Cancelled by NAFDAC |
| 45 | Mycobutin 150mg caps | Capsules | A4-4726 | Rifabutin 150mg | Pfizer Specialties Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 46 | Neo-Medrol Lotion | Lotion | 04-3778 | Methylprednisolone Acetate 2.5mg/neomycin sulphate 2.5mg | Pfizer Specialties Limited | Withdrawn Voluntarily by Market Authorization Holder |
| 47 | Fortum Injection | Powder for injection | 04- 2249 | Ceftazidime 1 gram (as Pentahydrate) | GlaxoSmithKline Pharmaceutical Nigeria Ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 48 | Proximexa Injection | Powder for injection | A4-5555 | Cefuroxime Axetil 500mg | GlaxoSmithKline Pharmaceutical Nigeria Ltd | Withdrawn Voluntarily by Market Authorization Holder |
| 49 | Diclo-Neurobion tablets | Tablets | A4-1231 | Diclofenac sodium 50 mg, Vitamin B1 50 mg, Vitamin B6 50 mg, Vitamin B12 0.25 mg | Fensyl MHP Consulting Ltd | Withdrawn Voluntarily by Market Authorization Holder |
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