View |
-
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VR-4407
|
Tulathromycin (Vet.)
|
Tulissin 25
|
25 mg/mL
|
Solution For Injection (SC/ IM)
|
Prescription Drug (RX)
|
Type I Glass Vial x 20 mL, 50 mL, 100 mL and 250 mL (Box of 1’s)
|
Antibacterial (Macrolide)
|
Fareva Amboise.
|
France
|
N/A
|
Virbac Philippines Inc.
|
Virbac Philippines Inc.
|
Initial (Vet.)
|
17 June 2022
|
17 June 2027
|
View |
|
VR-4408
|
Inactivated Porcine Circovirus Type 2 (PCV2)
Mesomycoplasma hyopneumoniae Vaccine (Vet.)
|
Ingelvac CircoFLEX-MycoFLEX
|
Processed under FDA Memorandum Circular 2021-001.
Formulation:
Each 2 mL (dose) contains:
Porcine Circovirus Type 2, ORF 2........................>1 RP Mesomycoplasma hyopneumoniae (B-3745 Isolate, J Strain) .........> 1RP RP - Relative Potency
|
Suspension for Injection (IM)
|
Prescription Drug (RX)
|
HDPE Bottles (2) with Rubber Stopper and Aluminum
Seal x 50 mL (Box of 1’s)
|
Veterinary Vaccine
|
Boehringer Ingelheim Animal Health USA Inc.
|
U.S.A
|
N/A
|
Boehringer Ingelheim Animal Health Philippines, Inc.
|
Boehringer Ingelheim Animal Health Philippines, Inc.
|
Renewal [Vet.]
|
17 June 2022
|
17 June 2027
|
View |
|
VR-4405
|
Modified Live Porcine Respiratory and Reproductive
Syndrome (PRRS) Virus + Inactivated Porcine Circovirus Type 2 (PCV2) + Mesomycoplasma hyopneumoniae Vaccine (Vet.)
|
3Flex
|
Formulation:
Each 2 mL (dose) contains:
Porcine Circovirus Type 2, ORF 2........................>1 RP Mesomycoplasma hyopneumoniae (B-3745 Isolate, J Strain) ......... > 1 RP Porcine Reproductive and Respiratory Syndrom Virus (VR-2332 Strain) ........ > 10^5.7 TCID 50
RP - Relative Potency
TCID- Tissue Culture Infective Dose
|
Freeze-Dried Powder for
Injection (IM)
|
Prescription Drug (RX)
|
Each set contains:
HDPE bottle with rubber stopper and alumunium seal containing the inactivated vaccines x 50 mL (Box of 2's) + Type I glass vial containing the
freeze-dried powder x 50 doses (Box of 1 set)
|
Veterinary Vaccine
|
Boehringer Ingelheim Animal Health USA Inc.
|
U.S.A
|
N/A
|
Boehringer Ingelheim Animal Health Philippines, Inc.
|
Boehringer Ingelheim Animal Health Philippines, Inc.
|
Renewal (Vet.]
|
17 June 2022
|
17 June 2027
|
View |
|
VR-4409
|
Inactivated Mesomycoplasma hyopneumoniae Vaccine
(Vet.)
|
RespiSure1 One
|
Formulation:
Each dose contains:
Mesomycoplasma hyopneumoniae (P-5722-3 (NL1042) Strain) ....... >7.5 x 10^8 CCU and 32 x 10^10 CCU
CCU-Color Changing Units
|
Emulsion for Injection (IM)
|
Prescription Drug (RX)
|
HDPE bottle with rubber stopper and aluminum seal x 20 mL and 100 mL
|
Veterinary Vaccine
|
Zoetis LLC
|
U.S.A
|
N/A
|
Zoetis Philippines, Inc.
|
Zoetis Philippines, Inc.
|
Renewal (Vet.)
|
20 June 2022
|
20 June 2027
|
View |
|
VR-4410
|
Inactivated Newcastle Disease (ND) Virus Vaccine (Vet.)
|
Poulvac iN LaSota
|
Formulation:
Each (0.5 mL) dose contains:
Newcastle Disease (ND) Virus B1 Type (LaSota strain)... >10^8 EID50
EID-Egg Infective Dose
|
Emulsion for Injection (IM/SC)
|
Prescription Drug (RX)
|
PET bottle with rubber stopper and aluminum seal x 500 mL
|
Veterinary Vaccine
|
Zoetis Industria de Produtos Veterinarios Ltda.
|
Brazil
|
N/A
|
Zoetis Philippines, Inc.
|
Zoetis Philippines, Inc.
|
Renewal (Vet.)
|
21 June 2022
|
21 June 2027
|
View |
|
VR-4411
|
Modified Live Tenosynovitis Virus Vaccine (Vet.) :
|
V.A. ChickVac
|
Formulation:
Each (0.2 mL) dose contains:
Tenosynovitis Virus (1133 strain) ...... >10^3.9 TCID50
TCID-Tissue Culture Infective Dose
|
Freeze Dried Powder for É Injection (SC)
|
Prescription Drug (RX)
|
Each set contains:
Type I glass vial with rubber stopper and aluminum seal x 1,000 doses + diluent x 200 mL (Box of 10's)
|
Veterinary Vaccine
|
Zoetis
|
U.S.A
|
N/A
|
Zoetis Philippines, Inc.
|
Zoetis Philippines, Inc.
|
Renewal (Vet.)
|
22 June 2022
|
22 June 2027
|
View |
|
VR-4412
|
Live Avian Encephalomyelitis (AE) + Fowl Pox (FP)
Virus Vaccine (Vet.)
|
AE- Poxine
|
Formulation:
Each 0.01 mL dose contains:
Avian Encephalomyelitis Virus (AE67 strain) .......... >10^3 EID 50 Fowl Pox Virus.................>10^2.6 EID 50
EID-Egg Infective Dose
|
Freeze Dried Powder for Injection (Wing Web)
|
Prescription Drug (RX)
|
Each set contains:
Type I glass vial with rubber stopper and aluminum seal x 1,000 doses + diluent x 10 mL (Box of 10's)
|
Veterinary Vaccine
|
Zoetis
|
U.S.A
|
N/A
|
Zoetis Philippines, Inc.
|
Zoetis Philippines, Inc.
|
Renewal (Vet.)
|
22 June 2022
|
22 June 2027
|
View |
|
VR-4413
|
Tulathromycin (Vet.)
|
Tulissin 100
|
100mg/ mL
|
Solution For Injection (IM/SC)
|
Prescription Drug (RX)
|
Type I Glass Vial x 20 mL, 50 mL, 100 mL and 250 mL (Box of 1’s)
|
Antibacterial (Macrolide)
|
Fareva Amboise
|
France
|
N/A
|
Virbac Philippines Inc.
|
Virbac Philippines Inc.
|
Initial (Vet.)
|
22 June 2022
|
22 June 2027
|
View |
|
VR-4414
|
Live Attenuated Porcine Reproductive and Respiratory
Syndrome (PRRS) Virus Vaccine (Vet.)
|
Porcilis PRRS
|
Formulation:
Each dose contains:
Porcine Reproductive and Respiratory Syndrome (DV Strain)........................> 10^4 TCID50 TCID - Tissue Culture Infective Dose
|
Freeze-Dried Pellet for Injection (IM/ID)
|
Prescription Drug (RX)
|
Type I Glass Vial with Halogenobutyl Rubber Stopper and Aluminum Cap x 50 and 100 doses (Box of 10's)
|
-
|
Intervet International B.V.
|
Netherlands
|
N/A
|
MSD Animal Health (Phils.), Inc.
|
N/A
|
Renewal (Variation) Vet.
|
22 June 2022
|
22 June 2027
|
View |
|
VR-4415
|
Inactivated Lawsonia intracellularis Vaccine (Vet.)
|
Porcilis Lawsonia
|
Each 2 mL (dose) contains:
Lawsonia intracellularis (SPAH-08 Strain)................>5323 U U - Antigenic Mass Unit ELISA
|
Freeze-Dried Powder for
Injection (IM)
|
Prescription Drug (RX)
|
Type I Glass Vial with Halogenobutyl Rubber Stopper and Aluminum Cap x 50 doses (Box of l’s)
|
-
|
Intervet International B.V.
|
Netherlands
|
N/A
|
MSD Animal Health (Phils.), Inc.
|
N/A
|
Renewal (Vet.)
|
22 June 2022
|
22 June 2027
|
View |
|
VR-4416
|
Aluminum Hydroxide + Mineral Oil in 0.9% Sodium
Chloride (Vet.)
|
Emunade
|
Formulation: Each 2 mL (dose) contains:
Light Mineral Oil ......222.4 mg Aluminium Hydroxide 3% (w/w)...............2 mg Glycerol .......226 mg Polysorbate 80 ................92.88 mg Sorbitan Monooleate ............45.30 mg Ethyl alcohol...................32.30 mg Sodium Hydroxide .........770 ug
Physiological Salt Solution ........................2 mL
|
Emulsion for Injection (IM/ID)
|
Prescription Drug (RX)
|
PET Bottle with Rubber Stopper and Aluminum Cap x
100 mL (Box of l’s)
|
Veterinary Vaccine (Adjuvanted Diluent)
|
Intervet International B.V.
|
Netherlands
|
N/A
|
MSD Animal Health (Phils.), Inc.
|
N/A
|
Initial [Vet.] correction
|
13 September 2022
|
24 June 2027
|
View |
|
VR-4417
|
Live Attenuated Newcastle Disease Virus (NDV) Vaccine
(Vet.)
|
Nobilis ND C2
|
Formulation:
Each dose contains:
Newcastle Disease Virus (Lentogenic C2 strain) ...............>5.7 log10 EID50
EID- Egg Infective Dose
|
Freeze dried pellet for
Suspension (Intraocular/Intranasal/Aerosol)
|
Prescription Drug (RX)
|
Type II glass vial with aluminum foil and rubber stopper
x 1000 doses and 5000 doses (Box of 10's)
|
Veterinary Vaccine
|
Intervet International B.V.
|
Netherlands
|
N/A
|
MSD Animal Health (Phils.), Inc.
|
MSD Animal Health (Phils.), Inc.
|
Renewal (Vet.)
|
27 June 2022
|
27 June 2027
|
View |
|
VR-4418
|
Live Newcastle Disease (ND) Virus Vaccine (Vet.)
|
Nobilis ND Clone 30
|
Formulation:
Each dose contains:
Newcastle Disease Virus (Lasota, Clone 30 Strain)..............> log^6 ELD50 ELD-Embryo Lethal Dose
|
Freeze dried pellet for Suspension (Aerosol/Oral/Intranasal/Intraocular)
|
Prescription Drug (RX)
|
Type I glass vial with aluminum foil and rubber stopper x 1000 doses and 5000 doses (Box of 10's)
|
Veterinary Vaccine
|
Intervet International B.V.
|
Netherlands
|
N/A
|
MSD Animal Health (Phils.), Inc.
|
N/A
|
Renewal (Vet.)
|
27 June 2022
|
27 June 2027
|
View |
|
VR-4419
|
Live Infectious Bronchitis (IB) Virus Vaccine (Vet.)
|
Nobilis IB 4-91
|
Formulation:
Each dose contains:
Infectious Bronchitis Virus (4-91 Strain) ................ >3.6 log10 EID50 EID-Egg Infectious Dose
|
Freeze dried powder for Suspension (Intranasal/Intraocular/Spray/Oral)
|
Prescription Drug (RX)
|
Alu laminate cup sealed with PP cup x 1000 doses and 5000 doses (Box of 12’s)
|
Veterinary Vaccine
|
Merck Sharp & Dohme Animal Health, S.L.
|
Spain
|
N/A
|
MSD Animal Health (Phils.), Inc.
|
MSD Animal Health (Phils.), Inc.
|
Renewal [Vet.)
|
27 June 2022
|
27 June 2027
|
View |
|
VR-4420
|
Live Infectious Bronchitis (IB) Virus Vaccine (Vet.)
|
Nobilis IB Ma5
|
Formulation:
Each dose contains:
Infectious Bronchitis Virus, Mild Mass H Type (Ma5 strain)........ >3 log10 EID50 EID- Egg Infectious Dose
|
Freeze dried powder for Suspension (Intranasal/Intraocular/Spray/Oral)
|
Prescription Drug (RX)
|
Alu laminate cup sealed with PP cap x 1000 doses and
5000 doses (Box of 12’s)
|
Veterinary Vaccine
|
Merck Sharp & Dohme Animal Health, S.L.
|
Spain
|
N/A
|
MSD Animal Health (Phils.), Inc.
|
MSD Animal Health (Phils.), Inc.
|
Renewal [Vet.)
|
27 June 2022
|
27 June 2027
|
View |
|
VR-4421
|
Inactivated Glaesserella parasuis Vaccine (Vet.)
|
Porcilis Glasser
|
Formulation:
Each dose (2 mL) contains:
Glaesserella parasuis Serotype 5 (4800 strain) ............>0.05 mg TN TN-Total Nitrogen
|
Suspension for Injection
(IM)
|
Prescription Drug (RX)
|
PET Bottle with rubber stopper and aluminum seal x
50 mL (Box of 1’s)
|
Veterinary Vaccine
|
Intervet International B.V.
|
Netherlands
|
|
MSD Animal Health (Phils.), Inc.
|
MSD Animal Health (Phils.), Inc.
|
Renewal [Vet.) correction
|
23 February 2023
|
28 June 2027
|
View |
|
VR-4422
|
Inactivated Actinobacillus pleuropneumoniae +
Mesomycoplasma hyopneumoniae Vaccine (Vet.)
|
APM777
|
Formulation:
Each 2 mL (dose) contains:
Actinobacillus pleuropneumoniae, Serotype 1 (41-1 Strain) ............... 1-5 x 109 Cells
Serotype 2 (SHP-1 Strain) ............... 1-5 x 10° Cells
Serotype 5 (Ng-2 Strain) ............... 1-5 x 10° Cells Actinobacillus pleuropneumoniae Cytotoxin rApx I, II, III Protein ....... 80-120 ug (Recombinant A. pleuropneumoniae produced in Escherichia coli) Mesomycoplasma hyopneumoniae (MI-3 Strain) .......... ........ 21 x 108 Cells
|
Vaccine
|
Prescription Drug (RX)
|
Type I Glass Bottle with Rubber Stopper and Aluminum
Seal x 100 mL (Box of 1's)
|
Veterinary Vaccine
|
Nisseiken Co., Ltd.
|
Japan
|
|
Superiorvet Inc.
|
Superiorvet Inc.
|
Initial
|
30 June 2022
|
30 June 2027
|
View |
|
VR-4423
|
Inactivated Actinobacillus pleuropneumoniae Vaccine
(Vet.)
|
AP125RX
|
Inactivated Actinobacillus pleuropneumoniae (Total bacterial count) 41-1 strain (serotype 1) (seed), SHP-1 strain 9serotype 2) (seed), Ng-2 strain (serotype 5) (seed)- 1.0x10^9 ~5.0x10^9 cells each; Non-toxigenic cytotoxic cytotoxins of Actinobacillus pleuropneumoniae (derived from recombinant Escherichia coli) rApx I Protein (seed), rApx II protein (seed), rApx III Protein (seed) - 80-120 mcg each
|
Suspension for Injection (IN
|
Prescription Drug (RX)
|
Type I Glass Bottle with Rubber Stopper and Aluminum
Seal x 100 mL (Box of 1's)
|
Veterinary Vaccine
|
Nisseiken Co., Ltd.
|
Japan
|
|
Superiorvet Inc.
|
Superiorvet Inc.
|
Initial
|
30 June 2022
|
30 June 2027
|
View |
|
VR-4424
|
Inactivated Mesomycoplasma hyopneumoniae Vaccine
(Vet.)
|
MPS
|
Formulation:
Each 1 mL (dose) contains:
Mesomycoplasma hyopneumoniae (MI-3 Strain) ...
21 x 108 Cells
|
Vaccine
|
Prescription Drug (RX)
|
PP Bottle with Rubber Stopper and Aluminum Seal x
50 mL (Box of 1's)
|
Veterinary Vaccine
|
Nisseiken Co., Ltd.
|
Japan
|
|
Superiorvet Inc.
|
Superiorvet Inc.
|
Initial
|
30 June 2022
|
30 June 2027
|
View |
|
VR-4425
|
Inactivated Rabies Virus Vaccine (Vet.)
|
Raksharab
|
Each 1 mL (dose) contains:
Rabies Virus (CVS Strain) .... IU - International Unit based on Glycoprotein unit
. 21 IU
|
Suspension for Injection
(IM/SC)
|
Prescription Drug (RX)
|
Type I Glass Vial with Grey Bromobutyl Rubber
Stopper and Aluminum Seal x 10 mL (Box of 5's)
|
Veterinary Vaccine
|
Indian Immunologicals Limited
|
India
|
|
UNAHCO, Inc.
|
UNAHCO, Inc.
|
Renewal [Vet.)
|
27 June 2022
|
27 June 2027
|