CERVARIX 20 MCG / 0.5 ML — DIN 02342227
RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN : 20 MCG / 0.5 ML RECOMBINANT HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN : 20 MCG / 0.5 ML · GLAXOSMITHKLINE INC · SUSPENSION · wholesale supply in Canada
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.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 20 MCG / 0.5 ML |
|---|---|
| Dosage form | SUSPENSION |
| Route | INTRAMUSCULAR |
| Pack configuration (monograph) | 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. |
| Storage | 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). |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation, because this listing covers more than one of them.
Substance and classification
| Active substance | Papillomavirus (Human Types 16,18) |
|---|---|
| ATC code | J07BM02 |
| AHFS class | 80:12.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02342227 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2342227 |
| 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 |
| Market authorization holder | GLAXOSMITHKLINE INC |
| Health Canada schedule | Schedule D |
| ATC code | J07BM02 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J07BM |
| Current status | MARKETED |
| Status date | 10-Feb-2010 |
| Original market date | 2010-02-10 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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.
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.
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
2 · Same class — other molecules in ATC J07BM
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Papillomavirus (Human Types 16,18) | CERVARIX | 1 | 1 | Yes |
| Papillomavirus (Human Types 6,11,16,18,31,33,45,52,58) | GARDASIL 9 | 1 | 1 | Yes |
| Papillomavirus (Human Types 6,11,16,18) | GARDASIL | 1 | 0 | Not in Canada |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC J07B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| J07BB | Influenza, Inactivated, Split Virus Or Surface Antigen · Influenza, Inactivated, Whole Virus · Influenza, Live Attenuated | 41 | 10 |
| J07BC | Combinations · Hepatitis A, Inactivated, Whole Virus · Hepatitis B, Purified Antigen | 19 | 9 |
| J07BN | Covid-19, Protein Subunit · Covid-19, Rna-Based Vaccine · Covid-19, Viral Vector, Non-Replicating | 28 | 5 |
| J07BD | Measles, Combin. With Mumps And Rubella, Live Attenuated · Measles, Combinations With Mumps, Rubella And Varicella, Live Attenuated · Morbilli, Comb. With Rubella, Live Attenuated · Morbilli, Live Attenuated | 8 | 4 |
| J07BX | Chikungunya Vaccines · Ebola Vaccines · Other Viral Vaccines · Respiratory Syncytial Virus Vaccine · Smallpox And Monkeypox Vaccines | 9 | 4 |
| J07BK | Varicella Zoster Vaccines · Varicella, Live Attenuated · Zoster, Live Attenuated | 7 | 3 |
| J07BG | Rabies, Inactivated, Whole Virus | 3 | 2 |
| J07BH | Rota Virus, Live Attenuated · Rota Virus, Pentavalent, Live, Reassorted | 2 | 2 |
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| AVAXIM | HEPATITIS A VIRUS, INACTIVATED : 160 UNIT / 0.5 ML | SANOFI PASTEUR LIMITED | MARKETED | 02237792 |
| COMIRNATY | *SARSCOV2 S-PROTEIN MRNA, 5'[M27,3'-OGPPP(M12'-O)APG], 3'POLYA+LINKER : 30 MCG / 0.3 ML | BIONTECH MANUFACTURING GMBH | MARKETED | 02552035 |
| HAVRIX 1440 | HEPATITIS A VIRUS, INACTIVATED : 1440 UNIT | GLAXOSMITHKLINE INC | MARKETED | 02187078 |
| HAVRIX 720 JUNIOR | HEPATITIS A VIRUS, INACTIVATED : 720 UNIT / 0.5 ML | GLAXOSMITHKLINE INC | MARKETED | 02231056 |
| MRESVIA | *RSV F-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA : 50 MCG / 0.5 ML | MODERNA BIOPHARMA CANADA CORPORATION | MARKETED | 02552914 |
| ROTARIX | ROTAVIRUS VACCINE (RIX4414 STRAIN), LIVE, ORAL, ATTENUATED (HUMAN) : 1000000 CCID50 / 1.5 ML | GLAXOSMITHKLINE INC | MARKETED | 02300591 |
| SPIKEVAX | *SARSCOV2 S-PROTEIN MRNA, 5'(M7G-5'-PPP-5'-GM), 3'POLYA : 0.1 MG | MODERNA BIOPHARMA CANADA CORPORATION | MARKETED | 02541270 |
| TWINRIX | HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) : 20 MCG / 1 ML HEPATITIS A VIRUS, INACTIVATED : 720 UNIT / 1 ML | GLAXOSMITHKLINE INC | MARKETED | 02230578 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
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. Patients and unlicensed buyers are routed to a partner pharmacy.
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.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
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.