CERVARIX 20 MCG / 0.5 ML
RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN : 20 MCG / 0.5 ML RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN : 20 MCG / 0.5 ML · DIN 02342227 · GLAXOSMITHKLINE INC
Health Canada status: MARKETED
What is CERVARIX?
CERVARIX 20 MCG / 0.5 ML contains RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN : 20 MCG / 0.5 ML RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN : 20 MCG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02342227, held by GLAXOSMITHKLINE INC, supplied as SUSPENSION for INTRAMUSCULAR administration. Health Canada currently lists it as marketed, status dated 10-Feb-2010. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is CERVARIX used for?
Prevention of cervical cancer and precancerous/dysplastic lesions (CIN 1, 2, 3; AIS) caused by oncogenic HPV types 16 and 18 in females aged 9 to 45 years.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02342227 |
|---|---|
| Brand name | CERVARIX |
| Generic / active ingredient | RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN : 20 MCG / 0.5 ML RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN : 20 MCG / 0.5 ML |
| Manufacturer | GLAXOSMITHKLINE INC |
| Strength | 20 MCG / 0.5 ML |
| Dosage form | SUSPENSION |
| Route of administration | INTRAMUSCULAR |
| Schedule | Schedule D |
| ATC code | J07BM02 PAPILLOMAVIRUS (HUMAN TYPES 16,18) |
| AHFS class | 80:12.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 10-Feb-2010 |
| Original market date | 2010-02-10 00:00:00 |
How is it administered?
9-14 years: 2-dose (0, 6 months) or 3-dose (0, 1, 6 months) schedule. 15-45 years: 3-dose schedule (0, 1, 6 months). Intramuscular injection in the deltoid.
Included because it drives pack selection and wastage. Consult the monograph.
How is it stored and handled?
A fine white deposit with clear supernatant may be observed upon storage; shake well before use to obtain white cloudy liquid. (Specific temperature not in text snippet).
How is it supplied?
0.5 mL suspension in a type I glass pre-filled syringe with a butyl rubber plunger stopper, with or without needles. Pack size of 1.
Contraindications
Known hypersensitivity to any component of the vaccine.
Warnings and precautions
Prophylactic only; not a treatment for existing HPV. Risk of syncope (observe for 15 min). Caution in patients with bleeding disorders. Postpone in acute severe febrile illness.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.