Republic Act (RA) No. 11534 known as the “Corporate Recovery and Tax Incentives for Enterprises (CREATE) Act” provided Value-Added Tax (VAT) Exemption to certain health products including, Drugs for Hypertension, Cancer, Mental Illnesses, Tuberculosis, Kidney Diseases, Diabetes, High Cholesterol, and COVID-19 medicines and medical devices. Pursuant to this, the Food and Drug Administration (FDA) is directed to identify and transmit the VAT-Exempt Health Products to other implementing agencies such as the Bureau of Internal Revenue (BIR), Bureau of Customs and Department of Trade and Industry.
It is stated in Section 12 of RA No. 11534 that VAT-Exemption of Medical Device, Drugs and Vaccine prescribed and directly used for COVID-19 treatment shall be valid until 31 December 2023. Relative thereto, the BIR has issued Revenue Memorandum Circular No. 7-2024, informing the stakeholders and all concerned that the said products shall no longer be VAT-Exempt, effective 01 January 2024.
In line with this, the following are hereby delisted from the List of VAT-Exempt Health Products in accordance with RMC No. 7-2024, appended herein. Further, the FDA Verification Portal shall be subsequently updated to reflect the said delisting.
I. Medicines for COVID-19 Treatment
| Generic Name | Dosage Strength | Dosage Form |
| Acetated Ringer’s | 1 L | Solution for Injection / Infusion, Bag |
| Acetated Ringer’s | 1 L | Solution for Injection / Infusion, Bottle |
| Acetated Ringer’s | 500 mL | Solution for Injection / Infusion, Bag |
| Acetated Ringer’s | 500 mL | Solution for Injection / Infusion, Bottle |
| Arbidol Hydrochloride | 100 mg | Tablet |
| Aspirin | 100 mg | Capsule |
| Aspirin | 100 mg | Enteric-Coated Tablet |
| Aspirin | 100 mg | Tablet |
| Aspirin | 300 mg | Tablet |
| Aspirin | 325 mg | Tablet |
| Aspirin | 80 mg | Delayed Release (DR) Tablet |
| Aspirin | 80 mg | Enteric-Coated Tablet |
| Aspirin | 80 mg | Film-Coated Tablet |
| Aspirin | 80 mg | Tablet |
| Atracurium | 10 mg/mL, 2.5 mL Ampule | Solution for Injection |
| Atracurium | 10 mg/mL, 5 mL Ampule | Solution for Injection |
| Atracurium (As Besilate) | 10 mg/mL (25 mg/ 2.5 mL) | Solution for Injection (I.V.) |
| Atracurium Besilate | 10 mg/mL (50 mg/5 mL) | Solution for Injection for I.V. Infusion |
| Azelastine Hydrochloride + Fluticasone Propionate | 137 mcg / 50 mcg per actuation | Nasal Suspension (Spray) |
| Balanced Multiple Maintenance Solution + 5% Dextrose | 1 L | Solution for Injection / Infusion, Bag |
| Balanced Multiple Maintenance Solution + 5% Dextrose | 1 L | Solution for Injection / Infusion, Bottle |
| Balanced Multiple Maintenance Solution + 5% Dextrose | 500 mL | Solution for Injection / Infusion, Bag |
| Balanced Multiple Maintenance Solution + 5% Dextrose | 500 mL | Solution for Injection / Infusion, Bottle |
| Balanced Multiple Replacement Solution + 5% Dextrose | 1 L | Solution for Injection / Infusion, Bag |
| Balanced Multiple Replacement Solution + 5% Dextrose | 1 L | Solution for Injection / Infusion, Bottle |
| Balanced Multiple Replacement Solution + 5% Dextrose | 500 mL | Solution for Injection / Infusion, Bag |
| Balanced Multiple Replacement Solution + 5% Dextrose | 500 mL | Solution for Injection / Infusion, Bottle |
| Baricitinib | 2 mg | Film-Coated Tablet |
| Baricitinib | 2 mg | Tablet |
| Baricitinib | 4 mg | Film-Coated Tablet |
| Baricitinib | 4 mg | Tablet |
| Beclometasone dipropionate + Formoterol fumarate dihydrate | 100 mcg / 6 mcg per actuation | Metered Dose Inhaler |
| Beclometasone dipropionate + Formoterol fumarate dihydrate | 200 mcg / 6 mcg per actuation | Metered Dose Inhaler |
| Beclometasone dipropionate + Formoterol fumarate dihydrate | 100 mcg / 6 mcg per actuation | Powder for Inhalation |
| Beclomethasone | 250 mcg/actuation, 200 Actuations | Metered Dose Inhaler |
| Beclomethasone + Formoterol + Glycopyrronium | 100 mcg + 6 mcg + 12.5 mcg/actuation, 120 Actuations | Metered Dose Inhaler |
| Bivalirudin | 250 mg | Lyophilized Powder for Injection (IV) |
| Budesonide | 200 mcg/actuation, 200 Actuations | Metered Dose Inhaler |
| Budesonide | 200 mcg/actuation, 300 Actuations | Metered Dose Inhaler |
| Budesonide | 250 mcg/mL (500 mcg/2 mL) | Suspension for Nebulization |
| Budesonide | 200 mcg | Pressurized Metered Dose Inhaler |
| Budesonide | 250 mcg/mL (500 mcg/mL) | Suspension for Nebulization |
| Budesonide | 200 mcg | Dry Powder in Capsule for Oral Inhalation |
| Budesonide | 500 mcg/mL (1000 mcg/2 mL) | Nebulizing Suspension (Sterile) |
| Budesonide | 200 mcg per Actuation | Metered Dose Inhaler |
| Budesonide | 250 mcg/mL | Respiratory Suspension |
| Budesonide | 200 mcg | Metered Dose Inhaler |
| Budesonide | 64 mcg per actuation | Aqueous Nasal Spray |
| Budesonide | 200 mcg/dose | Powder for Inhalation |
| Budesonide / Formoterol Fumarate Dihydrate | 80 mcg/4.5 mcg | Powder for Inhalation |
| Budesonide / Formoterol Fumarate Dihydrate | 320 mcg / 9 mcg per dose | Powder for Inhalation |
| Budesonide + Formoterol Fumarate Dihydrate | 200 mcg/6 mcg | Dry Powder for Inhalation |
| Budesonide + Formoterol Fumarate Dihydrate | 200 mcg/6 mcg | Metered Dose Pressurized Inhalation Suspension |
| Budesonide + Formoterol Fumarate Dihydrate | 80 mcg/ 4.5 mcg per Actuation | Inhalation Aerosol (Pressurized Suspension for Inhalation) |
| Budesonide + Formoterol Fumarate Dihydrate | 160 mcg/4.5 mcg per Actuation | Inhalation Aerosol (Pressurized Suspension for Inhalation) |
| Budesonide + Formoterol Fumarate Dihydrate | 400 mcg/ 12 mcg | Dry Powder for Inhalation |
| Budesonide + Formoterol Fumarate Dihydrate | 400 mcg/ 12 mcg | Dry Powder for Inhalation in Capsule |
| Budesonide + Formoterol Fumarate Dihydrate | 200 mcg/6 mcg | Metered Dose Pressurized Inhalation Suspension |
| Budesonide + Formoterol Fumarate Dihydrate | 80 mcg/ 4.5 mcg per Actuation | Inhalation Aerosol (Pressurized Suspension for Inhalation) |
| Budesonide + Formoterol Fumarate Dihydrate | 160 mcg/4.5 mcg per Actuation | Inhalation Aerosol (Pressurized Suspension for Inhalation) |
| Budesonide + Formoterol Fumarate Dihydrate | 400 mcg/ 12 mcg | Dry Powder for Inhalation |
| Budesonide + Formoterol Fumarate Dihydrate | 400 mcg/ 12 mcg | Dry Powder for Inhalation in Capsule |
| Casirivimab + Imdevimab | 120 mg/mL, 11.1 mL Vial + 120 mg/mL, 11.1 mL Vial | Solution for Infusion, Box |
| Casirivimab + Imdevimab | 120 mg/mL, 2.5 mL Vial + 120 mg/mL, 2.5 mL Vial | Solution for Infusion, Box |
| Casirivimab + Imdevimab | 120 mg /mL + 120 mg/mL | Concentrate for Solution for Infusion |
| Cefotaxime (As Sodium) | 1 g | Powder for Injection (I.M./I.V.) |
| Cefotaxime (As Sodium) | 500 mg | Powder for Injection (IM/IV) |
| Cefotaxime (as sodium) | 250 mg | Powder for Injection (IV/IM) |
| ChAdOx1-S [recombinant] (COVID-19 Vaccine AstraZeneca) | 0.5 mL | Solution for Injection |
| Clonazepam | 2 mg | Tablet |
| Clonazepam | 500 mcg | Tablet |
| Clopidogrel | 300 mg | Film-Coated Tablet |
| Clopidogrel | 75 mg | Capsule |
| Clopidogrel | 75 mg | Film-Coated Tablet |
| Clopidogrel | 75 mg | Tablet |
| Clopidogrel (As Bisulfate) | 75 mg | Film-Coated Tablet |
| COVID-19 mRNA Vaccine (nucleoside modified) [COVID-19 Vaccine Moderna] | 100 mcg | Suspension for Injection |
| COVID-19 Vaccine (Vero Cell) Inactivated [COVID-19 Vaccine Sinopharm] | 0.5 mL | Suspension for injection |
| COVID-19 Vaccine (Vero Cell), Inactivated [COVID-19 Vaccine Sinopharm (Beijing)] | 0.5 mL | Suspension for Injection |
| COVID-19 Vaccine (Vero Cell), Inactivated [COVID-19 Vaccine Sinopharm (Wuhan)] | 0.5 mL | Suspension for injection |
| COVID-19 Vaccine SARS-CoV-2 rS Protein Nanoparticle Vaccine (Covovax) | 0.5 mL | Suspension for Injection |
| Dalteparin Sodium | 2,500 IU/0.2 mL, 0.2 mL | Solution for Injection, Pre-filled Syringe |
| Dalteparin Sodium | 2500 IU/0.2 mL | Solution For Injection (SC) |
| Dexamethasone | 2 mg/mL, 2 mL | Solution for Injection, Ampule |
| Dexamethasone | 3 mg | Tablet |
| Dexamethasone | 4 mg | Tablet |
| Dexamethasone | 4 mg/mL, 1 mL | Solution for Injection, Ampule |
| Dexamethasone | 4 mg/mL, 1 mL | Solution for Injection, Vial |
| Dexamethasone | 4 mg/mL, 2 mL | Solution for Injection, Ampule |
| Dexamethasone | 4 mg/mL, 2 mL | Solution for Injection, Vial |
| Dexamethasone | 5 mg/mL, 1 mL | Solution for Injection, Ampule |
| Dexamethasone | 5 mg/mL, 100 mL | Solution for Injection, Vial |
| Dexamethasone | 50 mg/mL, 1 mL | Solution for Injection, Ampule |
| Dexamethasone | 500 mcg | Tablet |
| Dexamethasone | 750 mcg | Tablet |
| Dexamethasone | 4 mg/mL (8 mg/2 mL) | Solution For Injection (IM/IV) |
| Dexamethasone (as sodium phosphate) | 4 mg/mL | Solution for Injection (IM/IV) |
| Dexamethasone (as sodium phosphate) | 50 mg/mL | Solution for Injection (IM/IV) |
| Dexamethasone (as sodium phosphate) | 4 mg/mL (8 mg/2 mL) | Solution for Injection (IM/IV) |
| Dexamethasone (as sodium phosphate) | 5 mg/mL | Solution for Injection (IM/IV) |
| Dexamethasone (as sodium phosphate) | 5 mg/mL (10 mg/2 mL) | Solution for Injection (IM/IV) |
| Dexamethasone (as sodium phosphate) | 2 mg/mL | Solution for Injection (IM/IV) |
| Dexamethasone (as sodium phosphate) | 2 mg/mL (4 mg/2 mL) | Solution for Injection (IM/IV) |
| Dexamethasone Phosphate (as sodium) | 4 mg/mL | Solution for Injection (IV/IM) |
| Dextrose in Water | 10%, 1 L | Solution for Injection / Infusion, Bag |
| Dextrose in Water | 10%, 1 L | Solution for Injection / Infusion, Bottle |
| Dextrose in Water | 10%, 500 mL | Solution for Injection / Infusion, Bag |
| Dextrose in Water | 10%, 500 mL | Solution for Injection / Infusion, Bottle |
| Dextrose in Water | 5%, 1 L | Solution for Injection / Infusion, Bag |
| Dextrose in Water | 5%, 1 L | Solution for Injection / Infusion, Bottle |
| Dextrose in Water | 5%, 500 mL | Solution for Injection / Infusion, Bag |
| Dextrose in Water | 5%, 500 mL | Solution for Injection / Infusion, Bottle |
| Diazepam | 10 mg | Tablet |
| Diazepam | 5 mg | Tablet |
| Diazepam | 5 mg/mL, 2 mL | Solution for Injection, Ampule |
| Dobutamine | 12.5 mg/mL, 20 mL | Solution for Infusion, Vial |
| Dobutamine | 25 mg/mL, 10 mL | Solution for Injection, Ampule |
| Dobutamine | 250 mg | Powder, Vial |
| Dobutamine | 50 mg/mL, 5 mL | Solution for Injection, Ampule |
| Dobutamine (as hydrochloride) | 12.5 mg/mL | Solution for Injection (IV) |
| Dopamine | 40 mg/mL, 5 mL | Solution for Injection, Ampule |
| Dopamine in 5% Dextrose | 0.8 mg/mL, 250 mL | Solution for Infusion, Bottle |
| Dopamine in 5% Dextrose | 1.6 mg/mL, 250 mL | Solution for Infusion, Bottle |
| Enoxaparin | 100 mg (10,000 IU)/mL, 0.2 mL | Solution for Injection, Pre-Filled Syringe |
| Enoxaparin | 100 mg (10,000 IU)/mL, 0.4 mL | Solution for Injection, Pre-Filled Syringe |
| Enoxaparin | 100 mg (10,000 IU)/mL, 0.6 mL | Solution for Injection, Pre-Filled Syringe |
| Enoxaparin | 100 mg (10,000 IU)/mL, 0.8 mL | Solution for Injection, Pre-Filled Syringe |
| Enoxaparin Sodium | 4000 IU Anti-Factor Xa (Equivalent to 40 mg) 0.4 mL) | Solution for Injection (SC) |
| Enoxaparin Sodium | 60mg/0.6mL | Solution for Injection (IV/SC) |
| Enoxaparin Sodium | 4,000 IU/0.4mL (40 mg/0.4 mL) | Solution for Injection (SC) |
| Enoxaparin Sodium | 8,000 IU/0.8mL (80 mg/0.8 mL) | Solution for Injection (SC) |
| Enoxaparin Sodium | 6,000 IU/0.6mL (60 mg/0.6 mL) | Solution for Injection (SC) |
| Enoxaparin Sodium | 2,000 IU/0.2mL (20 mg/0.2 mL) | Solution for Injection (SC) |
| Enoxaparin Sodium | 4000 IU/0.4 mL) | Solution for Injection (IV/SC) |
| Enoxaparin Sodium | 6000 IU/0.6 mL) | Solution for Injection (IV/SC) |
| Enoxaparin Sodium | 40 mg/0.4 mL | Solution for Injection (IV/SC) |
| Enoxaparin sodium | 60 mg/0.6 mL | Solution For Injection (SC) |
| Enoxaparin sodium | 40 mg/0.4 mL | Solution For Injection (SC) |
| Enoxaparin sodium | 4000 IU (40 mg)/0.4 mL | Solution for Injection (IV/SC) |
| Enoxaparin Sodium | 6,000 IU (60 mg/0.6 mL) | Solution For Injection (IV/SC) |
| Enoxaparin Sodium | 40 mg/0.4 mL | Solution for Injection (SC) |
| Enoxaparin Sodium | 20 mg/0.2 mL | Solution for Injection (IV/SC) |
| Epinephrine | 1 mg/mL, 1 mL | Solution for Injection, Ampule |
| Favipiravir | 200 mg | Tablet |
| Favipiravir | 400 mg | Tablet |
| Favipiravir | 800 mg | Tablet |
| Fentanyl | 100 mcg | Sublingual Tablet |
| Fentanyl | 12.5 mcg/hr | Transdermal Patch |
| Fentanyl | 200 mcg | Sublingual Tablet |
| Fentanyl | 25 mcg/hr | Transdermal Patch |
| Fentanyl | 300 mcg | Sublingual Tablet |
| Fentanyl | 400 mcg | Sublingual Tablet |
| Fentanyl | 50 mcg/hr | Transdermal Patch |
| Fentanyl | 50 mcg/mL, 10 mL | Solution for Injection, Ampule |
| Fentanyl | 50 mcg/mL, 2 mL | Solution for Injection, Ampule |
| Fentanyl | 12 mcg/hr | Transdermal patch |
| Fentanyl (as Citrate) | 100 mcg (equivalent to 157.1 mcg Fentanyl citrate) | Sublingual Tablet |
| Fentanyl (As Citrate) | 200 mcg (equivalent to 314 mcg Fentanyl citrate) | Sublingual Tablet |
| Fentanyl (as citrate) | 10 mcg/mL | Solution for Injection (IV/SC) |
| Fentanyl (as citrate) | 50 mcg/mL | Solution for Injection (IM/IV) |
| Fentanyl (as citrate) | 50 mcg/mL (100 mcg/2 mL) | Solution for Injection (IM/IV) |
| Fentanyl (as citrate) | 100 mcg/2 mL (50 mcg/mL) | Solution for Injection (IM/IV) |
| Fluticasone | 125 mcg/actuation, 120 Actuations | Metered Dose Inhaler |
| Fluticasone + Formoterol | 125 mcg + 5 mcg/actuation, 120 Actuations | Metered Dose Inhaler |
| Fluticasone + Formoterol | 50 mcg + 5 mcg/actuation, 120 Actuations | Metered Dose Inhaler |
| Fluticasone + Salmeterol | 125 mcg + 25 mcg/actuation, 120 Actuations | Metered Dose Inhaler |
| Fluticasone + Salmeterol | 250 mcg + 25 mcg/actuation, 120 Actuations | Metered Dose Inhaler |
| Fluticasone + Salmeterol | 50 mcg + 25 mcg/actuation, 120 Actuations | Metered Dose Inhaler |
| Fluticasone + Salmeterol | 125 mcg / 25 mcg | Metered-Dose Inhaler |
| Fluticasone + Salmeterol | 250 mcg / 25 mcg | Metered-Dose Inhaler |
| Fluticasone Furoate | 27.5 mg/actuation | Suspension for Nasal Spray |
| Fluticasone Furoate + Umeclinidium (As Bromide) + Vilanterol (As Trifenatate) | 100 mcg / 62.5 mcg / 25 mcg | Dry Powder for Inhalation |
| Fluticasone Furoate + Vilanterol (As Trifenatate) | 100 mcg / 25 mcq (eq. to 92 mcg / 22 mcg delivered dose) | Dry Powder for Inhalation |
| Fluticasone Propionate | 500 mcg/mL (0.05% w/v) 50 mcg per actuation | Suspension for Nasal Spray |
| Fluticasone Propionate | 500 mcg/mL (50 mcg/0.1 mL spray) | Suspension for Nasal Spray |
| Fluticasone Propionate | 500 mcg/mL | Suspension of Nasal Spray |
| Fluticasone Propionate | 50 mcg | Aqueous Nasal Spray |
| Fluticasone Propionate | 125 mcg / actuation | Metered-Dose Inhaler (Non-CFC) |
| Fluticasone Propionate | 250 mcg/mL | Suspension for Inhalation (Nebules) |
| Fluticasone Propionate | 50 mcg / Actuation | Suspension for Nasal Spray |
| Fluticasone Propionate | 125 mcg per actuation | Metered-Dose Inhaler |
| Fluticasone Propionate | 50 mcg per Actuation | Nasal Spray |
| Fluticasone Propionate | 50 mcg | Nasal Spray |
| Fluticasone Propionate + Formoterol Fumarate dihyrate | 250 mcg / 10 mcg per actuation | Metered Dose Inhaler (Suspension) |
| Fluticasone Propionate + Formoterol Fumurate dihydate | 50 mcg / 5 mcg per actuation | Metered Dose Inhaler (Suspension) |
| Fondaparinux | 2.5 mg/0.5 mL, 0.5 mL | Solution for Injection, Pre-Filled Syringe |
| Fondaparinux Sodium | 10 mg/0.8 mL (12.5 mg/mL) | Solution For Injection (SC) |
| Fondaparinux Sodium | 7.5 mg/0.6 mL (12.5 mg/mL) | Solution For Injection (SC) |
| Fondaparinux Sodium | 5 mg/0.4 mL (12.5 mg/mL) | Solution For Injection (SC) |
| Haloperidol | 20 mg | Tablet |
| Haloperidol | 5 mg | Tablet |
| Haloperidol | 5 mg/mL, 1 mL | Solution for Injection, Ampule |
| Haloperidol | 50 mg/mL, 1 mL | Solution for Injection, Ampule |
| Heparin | 1000 IU/mL, 5 mL | Solution for Injection, Vial |
| Heparin | 5000 IU/mL, 5 mL | Solution for Injection, Vial |
| Heparin Sodium | 1,000 IU/mL (5,000 IU/5mL) | Solution for Injection (IV/SC) |
| Heparin Sodium | 5,000 IU/mL (25,000 IU/5mL) | Solution for Injection (IV/SC) |
| Heparin Sodium | 25,000 IU/5mL (5,000 IU/mL) | Solution for Injection (IV/SC) |
| Heparin Sodium | 10,000 IU/10 mL (1,000 IU/mL) | Solution for Injection (IV/SC) |
| Heparin Sodium | 5,000 IU/mL | Solution for Injection (IV/SC) |
| Heparin Sodium | 5,000 IU/5mL (1,000 IU/mL) | Solution for Injection (IV) |
| Heparin sodium | 1000 IU/mL | Solution for Injection (IV/SC) |
| Itolizumab | N/A | Lyophilized Powder for IV Injection |
| Ivermectin | 12 mg | Tablet |
| Janssen COVID-19 Vaccine (Ad26.COV2-S (recombinant)) | 5 x 1010 virus particles (VP) | Suspension for Injection |
| Ketamine | 50 mg/mL, 10 mL | Solution for Injection, Vial |
| Lactated Ringer’s + 5% Dextrose | 1 L | Solution for Injection / Infusion, Bag |
| Lactated Ringer’s + 5% Dextrose | 1 L | Solution for Injection / Infusion, Bottle |
| Lactated Ringer’s + 5% Dextrose | 500 mL | Solution for Injection / Infusion, Bag |
| Lactated Ringer’s + 5% Dextrose | 500 mL | Solution for Injection / Infusion, Bottle |
| Lactated Ringer’s Solution | 1 L | Solution for Injection / Infusion, Bag |
| Lactated Ringer’s Solution | 1 L | Solution for Injection / Infusion, Bottle |
| Lactated Ringer’s Solution | 500 mL | Solution for Injection / Infusion, Bag |
| Lactated Ringer’s Solution | 500 mL | Solution for Injection / Infusion, Bottle |
| Medical Grade Oxygen | N/A | N/A |
| Midazolam | 1 mg/mL, 3 mL | Solution for Injection, Ampule |
| Midazolam | 1 mg/mL, 5 mL | Solution for Injection, Ampule |
| Midazolam | 1 mg/mL, 5 mL | Solution for Injection, Vial |
| Midazolam | 15 mg | Film-Coated Tablet |
| Midazolam | 15 mg | Tablet |
| Midazolam | 5 mg/mL, 1 mL | Solution for Injection, Ampule |
| Midazolam | 5 mg/mL, 3 mL | Solution for Injection, Ampule |
| Molnupiravir | 200 mg | Capsule |
| Molnupiravir | 400 mg | Capsule |
| Morphine | 10 mg | Modified Release (MR) Tablet |
| Morphine | 10 mg | Tablet |
| Morphine | 10 mg/mL, 1 mL | Solution for Injection, Ampule |
| Morphine | 16 mg/mL, 1 mL | Solution for Injection, Ampule |
| Morphine | 30 mg | Tablet |
| Morphine | 60 mg | Modified Release (MR) Tablet |
| Nirmatrelvir + Ritonavir | 150 mg + 100 mg | Tablet |
| Nirmatrelvir + Ritonavir | 150 mg + 100 mg | Film-Coated Tablet |
| Norepinephrine | 1 mg/mL, 10 mL | Solution for Injection, Ampule |
| Norepinephrine | 1 mg/mL, 2 mL | Solution for Injection, Ampule |
| Norepinephrine | 1 mg/mL, 4 mL | Solution for Injection, Ampule |
| Norepinephrine | 2 mg/mL, 4 mL | Solution for Injection, Ampule |
| Norepinephrine (as bitartrate) | 1 mg/mL (4 mg/4 mL) | Solution for Injection (IV) |
| Norepinephrine (as bitartrate) | 1 mg/mL | Concentrate for IV Infusion |
| Norepinephrine (as bitartrate) | 1 mg/mL | Solution for Injection |
| Norepinephrine (as bitartrate) | 1 mg/mL (4 mg/4 mL) | Concentrate for Solution for IV Infusion |
| Oxycodone | 10 mg | Capsule |
| Oxycodone | 10 mg | Controlled-Release Tablet |
| Oxycodone | 10 mg/mL, 1 mL | Solution for Injection, Ampule |
| Oxycodone | 10 mg/mL, 2 mL | Solution for Injection, Ampule |
| Oxycodone | 15 mg | Controlled-Release Tablet |
| Oxycodone | 20 mg | Controlled-Release Tablet |
| Oxycodone | 30 mg | Controlled-Release Tablet |
| Oxycodone | 40 mg | Controlled-Release Tablet |
| Oxycodone | 5 mg | Capsule |
| Oxycodone | 5 mg/5 mL, 250 mL | Oral Solution, Bottle |
| Oxycodone | 60 mg | Controlled-Release Tablet |
| Oxycodone | 80 mg | Controlled-Release Tablet |
| Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) | 30 mcg | Suspension for Injection |
| Propofol | 10 mg/mL, 10 mL | Solution for Injection, Ampule |
| Propofol | 10 mg/mL, 10 mL | Solution for Injection, Vial |
| Propofol | 10 mg/mL, 20 mL | Solution for Injection, Ampule |
| Propofol | 10 mg/mL, 20 mL | Solution for Injection, Vial |
| Propofol | 10 mg/mL, 50 mL | Solution for Injection, Vial |
| Propofol | 10 mg/mL (1% w/v) | Emulsion for Injection (I.V./Infusion) |
| Remdesivir | 100 mg | Powder, Vial |
| Remdesivir | 5 mg/mL, 20 mL | Solution for Injection, Vial |
| Remdesivir | 100 mg /20 mL | Concentrate for Solution for IV Infusion |
| Remdesivir | 100 mg | Lyophilized Powder for Injection for I.V. Infusion |
| Rocuronium Bromide | 10 mg/mL, 5 mL | Solution for Injection, Vial |
| Rocuronium Bromide | 10 mg/mL | Solution for Injection (IV) |
| Salmeterol (As Xinafoate) / Fluticasone Propionate | 25 / 250 mcg | Metered Dose Inhaler |
| Salmeterol (as Xinafoate) + Fluticasone Propionate | 25 mcg / 250 mcg | Metered Dose Inhaler |
| Salmeterol (as Xinafoate) + Fluticasone Propionate | 25 mcg / 250 mcg | Metered Dose Inhaler (Suspension) |
| Salmeterol (as Xinafoate) + Fluticasone Propionate | 25 mcg / 125 mcg | Metered Dose Inhaler |
| Salmeterol (as Xinafoate) + Fluticasone Propionate | 25 mcg / 125 mcg | Metered Dose Inhaler (Suspension) |
| Salmeterol (as Xinafoate) + Fluticasone Propionate | 50 mcg / 100 mcg | Dry Powder for Inhalation Capsule |
| Salmeterol (as Xinafoate) + Fluticasone Propionate | 50 mcg / 250 mcg | Dry Powder for Inhalation in Capsule |
| Salmeterol (as Xinafoate) + Fluticasone Propionate | 50 mcg / 500 mcg | Dry Powder for Inhalation in Capsule |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 25 mcg / 125 mcg per Actuation | Metered Dose Inhaler (CFC) (120 doses) |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 25 mcg / 250 mcg per Actuation | Metered Dose Inhaler (CFC Free) (120 doses) |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 25 mcg / 125 mcg per actuation | Metered-Dose Inhaler |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 25 mcg / 125 mcg | Pressurized Metered Dose Inhaler (CFC Free) |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 25 mcg / 250 mcg | Pressurized Metered Dose Inhaler (CFC Free) |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 25 mcg + 250 mcg per Actuation Metered Dose | Pressurized Liquid for Inhalation |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 25 mcg / 125 mcg per Actuation Metered Dose | Pressurized Liquid for Inhalation |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 50 mcg / 500 mcg | Dry Powder for Inhalation |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 50 mcg / 250 mcg | Dry Powder Inhalation Capsule |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 25 mcg / 50 mcg per Actuation | Metered Dose Inhaler |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 50 mcg / 100 mcg per dose | Dry Powder for Inhalation |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 50 mcg / 250 mcg per dose | Dry Powder for Inhalation |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 25 / 250 mcg per Actuation | Metered Dose Inhaler (Suspension) |
| Salmeterol (As Xinafoate) + Fluticasone Propionate | 25 mcg / 250 mcg per actuation | Metered-Dose Inhaler |
| Salmeterol (As Xinofoate) / Fluticasone Propionate | 100 mcg / 50 mcg | Dry Powder for Inhalation (DPI) |
| Salmeterol Xinafoate + Fluticasone Propionate | 25 mcg / 125 mcg per Actuation | Metered Dose Inhaler |
| Salmeterol Xinafoate + Fluticasone Propionate | 50 mcg / 100 mcg | Dry Powder for Inhalation (In Capsule) |
| Salmeterol Xinafoate + Fluticasone Propionate | 50 mcg / 250 mcg | Dry Powder for Inhalation (In Capsule) |
| Salmeterol Xinafoate + Fluticasone Propionate | 50 mcg / 500 mcg | Dry Powder for Inhalation (In Capsule) |
| Salmeterol Xinafoate + Fluticasone Propionate | 25 mcg / 50 mcg | Metered Dose Inhaler |
| Salmeterol Xinafoate + Fluticasone Propionate | 25 mcg / 250 mcg | Metered Dose Inhaler |
| Salmeterol Xinafoate + Fluticasone Propionate | 50 mcg / 500 mcg | Powder for Inhalation |
| Salmeterol Xinafoate + Fluticasone Propionate | 50 mcg / 250 mcg | Powder for Inhalation |
| Salmeterol Xinafoate + Fluticasone Propionate | 50 mcg / 500 mcg | Powder for Inhalation |
| SARS-CoV-2 Vaccine (Vero Cell), Inactivated [Coronavac] | 600 SU/0.5 mL | Suspension for Injection |
| Sodium + Dextrose | 0.3% + 5%, 1 L | Solution for Injection / Infusion, Bag |
| Sodium + Dextrose | 0.3% + 5%, 1 L | Solution for Injection / Infusion, Bottle |
| Sodium + Dextrose | 0.3% + 5%, 500 mL | Solution for Injection / Infusion, Bag |
| Sodium + Dextrose | 0.3% + 5%, 500 mL | Solution for Injection / Infusion, Bottle |
| Sodium + Dextrose | 0.45% + 5%, 1 L | Solution for Injection / Infusion, Bag |
| Sodium + Dextrose | 0.45% + 5%, 1 L | Solution for Injection / Infusion, Bottle |
| Sodium + Dextrose | 0.45% + 5%, 500 mL | Solution for Injection / Infusion, Bag |
| Sodium + Dextrose | 0.45% + 5%, 500 mL | Solution for Injection / Infusion, Bottle |
| Sodium + Dextrose | 0.9% + 5%, 1 L | Solution for Injection / Infusion, Bag |
| Sodium + Dextrose | 0.9% + 5%, 1 L | Solution for Injection / Infusion, Bottle |
| Sodium + Dextrose | 0.9% + 5%, 500 mL | Solution for Injection / Infusion, Bag |
| Sodium + Dextrose | 0.9% + 5%, 500 mL | Solution for Injection / Infusion, Bottle |
| Sodium Chloride | 0.9%, 1 L | Solution for Injection / Infusion, Bag |
| Sodium Chloride | 0.9%, 1 L | Solution for Injection / Infusion, Bottle |
| Sodium Chloride | 0.9%, 500 mL | Solution for Injection / Infusion, Bag |
| Sodium Chloride | 0.9%, 500 mL | Solution for Injection / Infusion, Bottle |
| Sodium Chloride | 0.9%, 50 mL | Solution for I.V. Infusion (Parenteral) |
| Sodium Chloride | 0.9%, 100 mL | Solution for I.V. Infusion (Parenteral) |
| Sodium Chloride | 0.9%, 250 mL | Solution for I.V. Infusion (Parenteral) |
| Sputnik V Gam-COVID-Vac COVID-19 Vaccine | 0.5 ml | Solution for Injection |
| Suxamethonium | 20 mg/mL, 10 mL | Solution for Injection, Vial |
| Tinzaparin | 10,000 Anti-Xa IU/mL, 0.35 mL | Solution for Injection, Pre-Filled Syringe |
| Tinzaparin | 10,000 Anti-Xa IU/mL, 0.45 mL | Solution for Injection, Pre-Filled Syringe |
| Tinzaparin | 10,000 Anti-Xa IU/mL, 2 mL | Solution for Injection, Vial |
| Tinzaparin Sodium | 1,000 Anti-Xa IU/mL | Solution for Injection (SC) |
| Tocilizumab | 162 mg/0.9 mL, 0.9 mL | Solution for Injection, Pre-filled Syringe |
| Tocilizumab | 20 mg/mL, 10 mL | Solution for Infusion, Vial |
| Tocilizumab | 20 mg/mL, 20 mL | Solution for Infusion, Vial |
| Tocilizumab | 20 mg/mL, 4 mL | Solution for Infusion, Vial |
| Tocilizumab | 400 mg/ 20 mL | Concentrate for Solution for Infusion (IV) |
| Tocilizumab | 80 mg/ 4 mL (20mg/mL) | Concentrate for Solution for Infusion (IV) |
| Tocilizumab | 400 mg/20 mL (20 mg/mL) | Concentrate for Solution for Infusion (IV) |
| Tocilizumab | 200mg/10mL | Concentrate for Solution for Infusion (IV) |
| Vancomycin | 1 g | Powder, Vial |
| Vancomycin | 500 mg | Powder, Vial |
| Vancomycin | 1 g | Powder for Injection (I.V.) |
| Vancomycin | 500 mg | Powder for Injection (I.V.) |
| Vancomycin (as hydrochloride) | 500 mg | Powder For Injection (IV) |
| Vancomycin (as hydrochloride) | 1 g | Powder For Injection (IV) |
| Vancomycin (as hydrochloride) | 500 mg | Lyophilized Powder for IV Infusion |
| Vancomycin (as hydrochloride) | 1000 mg | Powder for Solution for Injection (IV) |
| Vancomycin (as hydrochloride) | 500 mg | Powder for Injection (IV Infusion) |
| Vancomycin (as hydrochloride) | 1 g | Powder for Injection (IV Infusion) |
| Vancomycin HCI | 125 mg | Capsule |
| Vasopressin | 20 IU/mL, 1 mL | Solution for Injection, Ampule |
| Vecuronium | 10 mg | Powder, Vial |
| Vecuronium | 4 mg | Powder, Vial |
| Warfarin | 1 mg | Tablet |
| Warfarin | 2.5 mg | Tablet |
| Warfarin | 5 mg | Tablet |
| Whole Virion, Inactivated Corona Virus Vaccine [Covaxin] | 6mcg (strain NIV-2020-770) | Solution for Injection |
II. COVID-19 Medical Device
| Category | Product |
| Personal Protective Equipment (PPE) | Gloves |
| Personal Protective Equipment (PPE) | Gowns including Aprons |
| Personal Protective Equipment (PPE) | Coveralls |
| Personal Protective Equipment (PPE) | Body Suits |
| Personal Protective Equipment (PPE) | Face Masks including N95 Masks, KN95 Masks, Cloth/Fabric Masks |
| Personal Protective Equipment (PPE) | Goggles |
| Personal Protective Equipment (PPE) | Shoe Cover |
| Personal Protective Equipment (PPE) | Face Shield for Medical Use |
| Personal Protective Equipment (PPE) | Head Cap/Cover |
| Personal Protective Equipment (PPE) | Personal Protective Equipment Set (Coverall, Shoe Cover, Goggles or Faceshield, Facemask, Head Cap) |
| Respiratory Devices and its accessories | Ventilator (All types) |
| Respiratory Devices and its accessories | Ventilator Breathing Circuit |
| Respiratory Devices and its accessories | Bacterial Filter for Breathing Circuit |
| Respiratory Devices and its accessories | Tubing and Support Set for Ventilator |
| Respiratory Devices and its accessories | Positive Pressure Breathing Device |
| Respiratory Devices and its accessories | Heated Breathing Circuit |
| Respiratory Devices and its accessories | Attachment, Breathing, Positive End Expiratory pressure |
| Respiratory Devices and its accessories | Resucitator |
| Respiratory Devices and its accessories | Oxygen Concentrator |
| Respiratory Devices and its accessories | High-Flow Respiratory Device/System |
| Respiratory Devices and its accessories | Nasal Cannula |
| Respiratory Devices and its accessories | Humidifier, Respiratory Gas (Direct Patient Interface) |
| Respiratory Devices and its accessories | Oxygen Mask |
| Respiratory Devices and its accessories | Tracheal Tube |
| Respiratory Devices and its accessories | Airway Monitoring System and Airway Clearing System |
| Respiratory Devices and its accessories | Accessory to Continuous Ventilator (Respirator) |
| Respiratory Devices and its accessories | High Efficiency Particulate Air (HEPA) Filter |
| Respiratory Devices and its accessories | Extracorporeal Membrane Oxygenation (ECMO) Machine |
| Respiratory Devices and its accessories | Nebulizing Kit and Nebulizer |
| COVID-19 Diagnostic Test Kits including transport collection, preservation medium/ tube with or without swab | COVID-19 Diagnostic Test Kits including transport collection, preservation medium/ tube with or without swab |
| Other specific medical devices | Anchor, preformed |
| Other specific medical devices | Bandage |
| Other specific medical devices | Cannula, Reusable |
| Other specific medical devices | Cap (Disinfection, Seal, Taper, Dead End) |
| Other specific medical devices | Clinical Thermometer (Except mercurial type) |
| Other specific medical devices | Cotton (Medical/hospital Use) |
| Other specific medical devices | Dressing/ Gauze |
| Other specific medical devices | Flowmeter (All types) |
| Other specific medical devices | Gloves |
| Other specific medical devices | Luer Lock |
| Other specific medical devices | Nasopharyngeal Airway |
| Other specific medical devices | Non-contact Infrared Thermometer |
| Other specific medical devices | Syringe |
| Other specific medical devices | Tape |
| Other specific medical devices | Pulse Oximeter including portable and fingertip |
| Other specific medical devices | Tubings |
| Personal Protective Equipment (PPE) | Air Purifying Respirators (for use in health care settings during response to the COVID-19 public health emergency) |
| Personal Protective Equipment (PPE) | Negative-Pressure SteriDome (NPS) |
| Personal Protective Equipment (PPE) | Individual Biocontainment Unit (IBU) |
| Personal Protective Equipment (PPE) | Airway Dome |
| Personal Protective Equipment (PPE) | Negative-Pressure Respiratory System |
| Personal Protective Equipment (PPE) | Patient Isolation Transport Unit (PITU) Device |
| Personal Protective Equipment (PPE) | Airborne Isolation Hood Device |
| Respiratory Devices and its Accessories | Continuous Positive Airway Pressure Circuit |
| Respiratory Devices and its Accessories | Intermittent Positive Pressure Breathing Device |
| Other Specific Medical Devices | Remote or Wearable Patient Monitoring Devices |
| Other Specific Medical Devices | Patient Isolation Transport Unit (PITU) |
| Other Specific Medical Devices | Symptom Screening Tool |
| Respiratory Devices and its Accessories | Inhalation Sedation Equipment |
| Respiratory Devices and its Accessories | Inhalation Sedation Equipment |
Should you have any question/clarifications, you may contact the FDA Policy and Planning Service via email at [email protected].
Dissemination of this Advisory to all concerned is kindly requested.