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Name of the medicinal product Pemetrexed 500 mg powder for concentrate for solution for infusion Pemetrexed 100 mg powder for concentrate for solution for infusion Qualitative and quantitative composition a) Each sterile lyophilized vial contains: Pemetrexed Disodium Heptahydrate Ph.Eur Equivalent to pemetrexed 500mg Mannitol USP […]
Methotrexate Injection BP 25mg/ml (1gm/40ml) Technical Specification: Product Name: Methotrexate Injection BP 25mg/ml (1gm/40ml) Brand Name: Methotrexate Strength: 7.5mg/ml, 15mg/ml, 20mg/ml, 25mg/ml, 50mg/2ml – Ampoule, 5mg/ml (15mg/3ml), 25mg/ml (50mg/2ml, 250mg/10ml, 500mg/20ml, 1gm/40ml), 100mg/ml (500mg/5ml, 1000mg/10ml) – Vial Dosage Form: Liquid Injection Packing: SINGLE USE Route of Administration: For I.M./I.A./ I.V. use Pack Insert/Leaflet: PIL (Patient […]
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, […]
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: […]
Carboplatin Injection BP 10mg/ml (450mg/45ml) Technical Specification: Product Name: Carboplatin Injection BP 10mg/ml (450mg/45ml) Brand Name: Carboplatin Strength: 10mg/ml (50mg/5ml, 150mg/15ml, 450mg/45ml, 600mg/60ml) Dosage Form: Liquid Injection Packing: MULTI-DOSE 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, […]
Vincristin Sulfate Injection USP 1mg (Vratucan) Technical Specification: Product Name: Vincristin Sulfate Injection USP 1mg Brand Name: Vratucan Strength: 1mg/ml Dosage Form: Liquid 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 Studies, GMP, CTD Dossier […]
Vinorelbine Injection USP 50mg/5ml Technical Specification: Product Name: Vinorelbine Injection USP 50mg/5ml Brand Name: Vinorelbine Strength: 10mg/ml, 50mg/5ml Dosage Form: Liquid Injection Packing: SINGLE-USE VIAL Route of Administration: For I.V. use only – Must be diluted before Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, […]
Mercaptopurine Tablets USP 50mg Technical Specification: Product Name: Mercaptopurine Tablets USP 50mg Brand Name: Mercaptopurine Strength: 10mg, 50mg Dosage Form: uncoated Tablet Packing: 10s, 25s, 30s, 60s, 250s Route of Administration: For Oral Use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD […]
Gefitinib Tablets 100mg Technical Specification: Product Name: Gefitinib Tablets 100mg Brand Name: Gefitinib Strength: 100mg, 250mg Dosage Form: Film-coated Tablet Packing: 10s, 30s Route of Administration: For Oral 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-Cancer Indication: […]
Gefitinib Tablets 250mg Technical Specification: Product Name: Gefitinib Tablets 250mg Brand Name: Gefitinib Strength: 100mg, 250mg Dosage Form: Film-coated Tablet Packing: 10s, 30s Route of Administration: For Oral 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-Cancer Indication: […]
Etoposide Capsules USP 100mg Technical Specification: Product Name: Etoposide Capsules USP 100mg Brand Name: Generics Strength: 50mg, 100mg Dosage Form: Hard-Gelatin Capsules Packing: 4s, 12s, 8s, 20s Route of Administration: For Oral Use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier […]
Abiraterone Acetate Tablets USP 250mg Technical Specification: Product Name: Abiraterone Acetate Tablets USP 250mg Brand Name: Generics Strength: 250mg, 500mg Dosage Form: Tablets Packing: 60s, 120s Route of Administration: For Oral 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 […]
Daunorubicin Hydrochloride for Injection USP 20mg (Oxirvera) Technical Specification: Product Name: Daunorubicin Hydrochloride for Injection USP 20mg Brand Name: Oxirvera Strength: 20mg Dosage Form: Lyophilized Dry Powder for Injection Packing: SINGLE USE VIAL Route of Administration: For I.V. infusion only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, […]
Azacitidine for Injection 100mg Technical Specification: Product Name: Azacitidine for Injection 100mg Brand Name: Dessraunt Strength: 50mg, 100mg, 150mg Dosage Form: Lyophilized Dry Powder for Injection Packing: SINGLE USE VIAL Route of Administration: For Subcutaneous, Intravenous use only Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability […]
Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml) Technical Specification: Product Name: Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml) Brand Name: Leucovorin Strength: 10mg/ml (50mg/5ml, 100mg/10ml, 175mg/17.5ml, 250mg/25ml, 300mg/30ml, 500mg/50ml – VIAL) 15mg/ 2ml – Ampoule Dosage Form: Liquid Injection Packing: SINGLE USE VIAL Route of […]
Powder for suspension for Injection Triptorelin 22.5mg (Prostazar SR) Technical Specification: Product Name: Powder for suspension for Injection Triptorelin 22.5mg Brand Name: Prostazar SR Strength: 3.75mg, 11.25mg, 22.5mg Dosage Form: Lyophilized Dry Powder for Injection Packing: SINGLE USE VIAL Route of Administration: For I.M. use only Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) […]
Bicalutamide Tablets USP 50mg Technical Specification: Product Name: Bicalutamide Tablets USP 50mg Brand Name: Bicalutamide Strength: 50mg, 150mg Dosage Form: Film-coated Tablet Packing: 10s, 28s, 30s, 50s Route of Administration: For Oral Use only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier […]
Zoledronic acid Injection 4mg Technical Specification: Product Name: Zoledronic acid Injection 4mg Brand Name: Zoledronic Strength: 4mg Dosage Form: Lyophilized Dry Powder for Injection Packing: SINGLE USE VIAL Route of Administration: For I.V. infusion only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD […]
Vindesine Sulfate for Injection BP 1mg (Cilretta) Technical Specification: Product Name: Vindesine Sulfate for Injection BP 1mg Brand Name: Cilretta Strength: 1mg, 5mg Dosage Form: Lyophilized Dry Powder for Injection Packing: SINGLE USE VIAL Route of Administration: For I.V. infusion only. Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) Regulatory Documents: COA, MOA, […]
