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Phenoxymethylpenicillin Tablets BP 500mg Technical Specification: Product Name: Phenoxymethylpenicillin Tablets BP Brand Name: PHENI-V Strength: 250mg, 500mg Dosage Form: Tablets Route of Administration: Via Oral Route Packing: 10s, 30s, 100s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier Therapeutic use: Beta Lactam […]
Levetiracetam tablets 250mg Technical Specification: Product Name: Levetiracetam tablets 250mg Brand Name: Generics Strength: 250mg, 500mg, 750mg, 1000mg Dosage Form: Tablets (Film-coated) Route of Administration: Via oral Route Packing: 30s, 60s, 100s, 500s, 1000s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, […]
Abacavir Tablets USP 300mg Technical Specification: Product Name: Abacavir Tablets USP Brand Name: Generic Strength: 300mg Dosage Form: Tablets (Film-coated) Route of Administration: Via Oral Route Packing: 10s, 30s, 100s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier Therapeutic use: Anti-HIV, […]
Levetiracetam tablets 1000mg Technical Specification: Product Name: Levetiracetam tablets 1000mg Brand Name: Generics Strength: 250mg, 500mg, 750mg, 1000mg Dosage Form: Tablets (Film-coated) Route of Administration: Via oral Route Packing: 30s, 60s, 100s, 500s, 1000s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, […]
Levetiracetam tablets 750mg Technical Specification: Product Name: Levetiracetam tablets 750mg Brand Name: Generics Strength: 250mg, 500mg, 750mg, 1000mg Dosage Form: Tablets (Film-coated) Route of Administration: Via oral Route Packing: 30s, 60s, 100s, 500s, 1000s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, […]
Hydralazine Hydrochloride Injection USP 20 mg/ml Technical Specification: Product Name: Hydralazine Hydrochloride Injection USP 20 mg/ml Brand Name: Hydrataj Strength: 20mg/ml Dosage Form: Ampoules Packing: 10 x 1 Ampoules Route of Administration: Intramuscular, Intravenous use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, […]
Parecoxib Sodium Injection 40mg Technical Specification: Product Name: Parecoxib Sodium Injection 40mg Brand Name: Generic Strength: 40mg/2ml Dosage Form: Lyophilized Dry Powder Solution Packing: 1 Vial + 1 Ampule Route of Administration: For IV/IM use only Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, […]
Etoricoxib Tablets 90mg Technical Specification: Product Name: Etoricoxib Tablets Brand Name: Rezoxib Strength: 60mg, 90mg, 120mg Dosage Form: Tablets(film-coated) Route of Administration: Via Oral Route Packing: 10s, 30s, 100s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet) Documents: COA, MOA, Stability Studies, GMP Therapeutic use: Antirheumatic, Analgesic and Anti-inflammatory Indication: Etoricoxib is indicated in adults and […]
Abacavir and Lamivudine tablet USP 600mg/300mg Technical Specification: Product Name: Abacavir and Lamivudine tablet USP Brand Name: Generic Strength: 600mg/300mg Dosage Form: Tablets (Film-coated) Route of Administration: Via Oral Route Packing: 10s, 30s, 100s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD […]
Levofloxacin Intravenous Infusion USP 500mg (Levotaj) Technical Specification: Product Name: Levofloxacin Intravenous Infusion USP 500mg Brand Name: Levoxtaj Strength: (0.5% W/V or 500mg/100ml or 5mg/ml) Dosage Form: I.V. Infusion Bottle (LVP) Packing: 100mL IV Bottle Route of Administration: For I.V. use only Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, […]
Etoricoxib Injection 90mg/ml Technical Specification: Product Name: Etoricoxib Injection Brand Name: Rezoxib Strength: 90mg/ml Dosage Form: Liquid Injection Route of Administration: For Intravenous or Intramuscular use only (I.V. & I.M.) Packing: 5 x 1ml ampules Pack Insert/Leaflet: PIL (Patient Information Leaflet) Documents: COA, MOA, Stability Studies, GMP Therapeutic use: Antirheumatic, Analgesic and Anti-inflammatory Indication: Etoricoxib […]
Etoricoxib Injection 90mg/ml Technical Specification: Product Name: Etoricoxib Injection Brand Name: Rezoxib Strength: 90mg/ml Dosage Form: Liquid Injection Route of Administration: For Intravenous or Intramuscular use only (I.V. & I.M.) Packing: 1ml Vial Pack Insert/Leaflet: PIL (Patient Information Leaflet) Documents: COA, MOA, Stability Studies, GMP Therapeutic use: Antirheumatic, Analgesic and Anti-inflammatory Indication: Etoricoxib is indicated […]
Oxytocin Injection 10 I.U. Technical Specification: Product Name: Oxytocin Injection 10 I.U. Brand Name: Oxytocin Injection Strength: 10 I.U. Dosage Form: Liquid Injection (SVP) Packing: 5 x 1 ml ampoules Route of Administration: For I.V. and I.M. use only Pack Insert/Leaflet: PIL (Patient Information Leaflet) Documents: COA, MOA, Product Permission, Stability Studies, GMP Therapeutic use: […]
Oxycodone Hydrochloride and Acetaminophen Tablet USP (7.5mg + 375mg) Technical Specification: Product Name: Oxycodone Hydrochloride and Acetaminophen Tablet USP (7.5mg + 375mg) Brand Name: OXYCONTEX II Vance Strength: (7.5mg + 375mg) Dosage Form: Extended-Release Tablets (film-coated) Route of Administration: Via Oral Route Packing: 10s, 20s, 30s, 50s, 150s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC […]
Oxaliplatin Injection USP (100mg) Technical Specification: Product Name: Oxaliplatin Injection USP Brand Name: Generic Strength: (50mg), (100mg) Dosage Form: Liquid Innjection Packing: SINGLE-USE VIAL Route of Administration: For I.V. Use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier Therapeutic use: Anti […]
Doxorubicin Hydrochloride for Injection BP 10mg Technical Specification: Product Name: Doxorubicin Hydrochloride for Injection BP 10mg Brand Name: DOXOTAJ Strength: 50mg,10mg Dosage Form: Lyophilised Powder Injection (Sterile) *Preservative-free Packing: Single dose Vial Route of Administration: For I.V. use only (After dilution) Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, […]
Epirubicin Hydrochloride for Injection 100mg Technical Specification: Product Name: Epirubicin Hydrochloride for Injection 100mg Brand Name: Epirubicin Strength: 10mg, 50mg, 100mg Dosage Form: Lyophilized Dry Powder for Injection Packing: SINGLE-USE VIAL Route of Administration: For I.V. use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability […]
Epirubicin Hydrochloride for Injection 10mg Technical Specification: Product Name: Epirubicin Hydrochloride for Injection 10mg Brand Name: Epirubicin Strength: 10mg, 50mg, 100mg Dosage Form: Lyophilized Dry Powder for Injection Packing: SINGLE USE VIAL Route of Administration: For I.V. use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, […]
Epirubicin Hydrochloride for Injection 50mg Technical Specification: Product Name: Epirubicin Hydrochloride for Injection 50mg Brand Name: Epirubicin Strength: 10mg, 50mg, 100mg Dosage Form: Lyophilized Dry Powder for Injection Packing: SINGLE USE VIAL Route of Administration: For I.V. use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, […]
Deferasirox Dispersible Tablets 400mg Technical Specification: Product Name: Deferasirox Dispersible Tablets 400mg Brand Name: Defrataj Strength: 100mg, 125mg, 250mg, 400mg, 500mg Dosage Form: Tablets (Dispersible uncoated tablet) Route of Administration: Via oral Route Packing: 10s, 30s, 90s, 100s, 500s, 1000s Pack Insert/Leaflet: PIL (Patient Information Leaflet) Regulatory Documents: COA, MOA, Product Permission, Stability Studies, GMP […]
Deferasirox Dispersible Tablets 100mg Technical Specification: Product Name: Deferasirox Dispersible Tablets 100mg Brand Name: Defrataj Strength: 100mg, 125mg, 250mg, 400mg, 500mg Dosage Form: Tablets (Dispersible uncoated tablet) Route of Administration: Via oral Route Packing: 10s, 30s, 90s, 100s, 500s, 1000s Pack Insert/Leaflet: PIL (Patient Information Leaflet) Regulatory Documents: COA, MOA, Product Permission, Stability Studies, GMP […]
Doxorubicin Hydrochloride for Injection BP 50mg Technical Specification: Product Name: Doxorubicin Hydrochloride for Injection BP 50mg Brand Name: DOXOTAJ Strength: 50mg,10mg Dosage Form: Lyophilised Powder Injection (Sterile) *Preservative-free Packing: Single dose Vial Route of Administration: For I.V. use only (After dilution) Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, […]
Doxorubicin Hydrochloride for Injection BP 10mg Riyadh Technical Specification: Product Name: Doxorubicin Hydrochloride for Injection BP 10mg Riyadh Brand Name: DOXOTAJ Strength: 50mg,10mg Dosage Form: Lyophilised Powder Injection (Sterile) *Preservative-free Packing: Single dose Vial Route of Administration: For I.V. use only (After dilution) Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: […]
Febuxostat Tablet 40mg Oman Technical Specification: Product Name: Febuxostat Tablet Oman Brand Name: Generics Strength: 40mg, 80mg, 120mg Dosage Form: Tablet (Film-coated) Route of Administration: Via oral Route Packing: 30s, 90s, 100s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier Therapeutic use: […]
