| Product Information |
|
| Registration Number |
BR-1089
|
| Generic Name |
Measles, Mumps, Rubella and Varicella Vaccine (Live)
|
| Brand Name |
Proquad
|
| Dosage Strength |
Each dose (0.5 mL) contains: Measles virus (Edmonston B) 3.00 log TCID50* Mumps virus (Jeryl Lynn B level)4.30 log TCID50
Rubella virus (Wistar RA 27/3) 3.00 log TCID50
Varicella virus (Oka/Merck) 3.99 PFU**
*50% Tissue Culture Infectious Dose
**Plaque Forming Units
|
| Dosage Form |
Lyophilized Powder For Solution For Injection (SC)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
3 mL USP/Ph. Eur. Type I glass vial with grey rubber stopper and aluminum flip-off seal (as drug product) 0.7 mL in 1 mL Type I pre-filled needleless glass syringe with black rubber stopper and grey ribbed tip cap (as Sterile Water for Injection) [Box of 1's and 10's].
|
| Pharmacologic Category |
Vaccines
|
| Manufacturer |
Merck Sharp & Dohme LLC
|
| Country of Origin |
U.S.A
|
| Trader |
N/A
|
| Importer |
Merck Sharp & Dohme (I.A.) LLC
|
| Distributor |
N/A
|
| Application Type |
Initial (from Monitored Release) [Correction]
|
| Issuance Date |
11 March 2024
|
| Expiry Date |
09 June 2025
|