PENTACEL 20 MCG / 0.5 ML — DIN 02231343
PERTUSSIS TOXOID : 20 MCG / 0.5 ML TETANUS PROTEIN : 30 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1 : 8 UNIT / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 20 MCG / 0.5 ML DIPHTHERIA TOXOID : 15 LF / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT : 32 UNIT / 0.5 ML FIMBRIAE : 5 MCG / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML HAEMOPHILUS INFLUENZAE TYPE B-PRP : 10 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY : 40 UNIT / 0.5 ML TETANUS TOXOID : 5 LF / 0.5 ML · SANOFI PASTEUR LIMITED · LIQUID ; POWDER FOR SOLUTION · wholesale supply in Canada
Health Canada status: CANCELLED POST MARKET
What is PENTACEL?
PENTACEL 20 MCG / 0.5 ML contains PERTUSSIS TOXOID : 20 MCG / 0.5 ML TETANUS PROTEIN : 30 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1 : 8 UNIT / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 20 MCG / 0.5 ML DIPHTHERIA TOXOID : 15 LF / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT : 32 UNIT / 0.5 ML FIMBRIAE : 5 MCG / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML HAEMOPHILUS INFLUENZAE TYPE B-PRP : 10 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY : 40 UNIT / 0.5 ML TETANUS TOXOID : 5 LF / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02231343, held by SANOFI PASTEUR LIMITED, supplied as LIQUID ; POWDER FOR SOLUTION for INTRAMUSCULAR administration. Health Canada currently lists it as cancelled post market, status dated 12-Nov-2024. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.
What is PENTACEL used for?
PENTACEL® is indicated for the primary immunization of infants, from the age of 2 months, and in children up to 6 years of age (prior to their 7th birthday), against invasive Haemophilus influenzae type b disease, diphtheria, tetanus, pertussis (whooping cough) and poliomyelitis.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Is there a generic Dipht-Hemoph Influen B-Pertuss-Polio-Tetanus in Canada, and who makes it?
Every market authorization holder with a Canadian DIN for this molecule, and how many of their listings Health Canada currently shows as marketed.
3 holders have a Canadian DIN containing Dipht-Hemoph Influen B-Pertuss-Polio-Tetanus, across 4 DINs, of which 2 are currently marketed. Marketed count is the number that matters: an approval that is not marketed cannot be bought.
| Market authorization holder | DINs | Marketed | Brand names | Position |
|---|---|---|---|---|
| SANOFI PASTEUR LIMITED | 2 | 1 | PENTACEL | Sourceable in Canada |
| GLAXOSMITHKLINE INC | 1 | 1 | INFANRIX-IPV/HIB | Sourceable in Canada |
| SANOFI VACCINES CANADA LTD. | 1 | 0 | PEDIACEL | No marketed DIN |
Health Canada’s Drug Product Database does not flag which listing is the originator and which are subsequent-entry products, so Nexara does not label them here. Interchangeability is determined provincially, not federally — confirm for your province before a formulary switch. Nexara can confirm which of these is actually obtainable, and on what lead time, per order.
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 | LIQUID ; POWDER FOR SOLUTION |
| Route | INTRAMUSCULAR |
| Pack configuration (monograph) | null |
| Storage | null |
Pack detail is kept as a regulatory record. This DIN is no longer authorized for sale in Canada, so Nexara does not quote this pack.
Substance and classification
| Active substance | Dipht-Hemoph Influen B-Pertuss-Polio-Tetanus |
|---|---|
| ATC code | J07CA06 |
| 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) | 02231343 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2231343 |
| Brand name | PENTACEL |
| Generic / active ingredient | PERTUSSIS TOXOID : 20 MCG / 0.5 ML TETANUS PROTEIN : 30 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 2 MEF1 : 8 UNIT / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 20 MCG / 0.5 ML DIPHTHERIA TOXOID : 15 LF / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 3 SAUKETT : 32 UNIT / 0.5 ML FIMBRIAE : 5 MCG / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML HAEMOPHILUS INFLUENZAE TYPE B-PRP : 10 MCG / 0.5 ML INACTIVATED POLIOMYELITIS VACCINE (D.C.O.) TYPE 1 MAHONEY : 40 UNIT / 0.5 ML TETANUS TOXOID : 5 LF / 0.5 ML |
| Market authorization holder | SANOFI PASTEUR LIMITED |
| Health Canada schedule | Schedule D |
| ATC code | J07CA06 |
| ATC anatomical main group | J — Anti-infectives for systemic use |
| ATC therapeutic subgroup | J07CA |
| Current status | CANCELLED POST MARKET |
| Status date | 12-Nov-2024 |
| Original market date | 1997-06-16 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
How is it administered?
4-dose series at 2, 4, 6, and 18 months of age. Administer 0.5 mL dose via intramuscular injection. Reconstitute Act-HIB with QUADRACEL before use.
Included because it drives pack selection and wastage. Consult the monograph.
Contraindications
Systemic hypersensitivity to any component; encephalopathy within 7 days of previous pertussis vaccine; progressive neurologic disorders (infantile spasms, uncontrolled epilepsy).
Warnings and precautions
Do not administer intravascularly. Postpone in acute/febrile disease. Caution in patients with bleeding disorders or history of GBS within 6 weeks of tetanus vaccine.
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.
1 · Same molecule, other Canadian presentations
2 of 4 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| INFANRIX-IPV/HIB | 25 MCG / 0.5 ML | SUSPENSION | GLAXOSMITHKLINE INC | MARKETED | 02257122 |
| PENTACEL | 29 UNIT / 0.5 ML | SUSPENSION | SANOFI PASTEUR LIMITED | MARKETED | 02534797 |
| PEDIACEL | 20 MCG / 0.5 ML | SUSPENSION | SANOFI VACCINES CANADA LTD. | CANCELLED POST MARKET | 02243167 |
2 · Same class — other molecules in ATC J07CA
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Diphtheria-Pertussis-Poliomyelitis-Tetanus | ADACEL-POLIO · BOOSTRIX-POLIO · DPT POLIO ADSORBED VACCINES · INFANRIX HEXA · +2 more | 7 | 4 | Yes |
| Dipht-Hemoph Influen B-Pertuss-Polio-Tetanus | INFANRIX-IPV/HIB · PEDIACEL · PENTACEL | 4 | 2 | Yes |
| Diphtheria-Poliomyelitis-Tetanus | DT POLIO ADSORBED - SUS IM · TD POLIO ADSORBED | 2 | 0 | Not in Canada |
| Bacterial And Viral Vaccines, Combined | T POLIO ADSORBED | 1 | 0 | Not in Canada |
| Typhoid-Hepatitis A | VIVAXIM | 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.
4 · Fixed-dose combinations with Canadian supply
| Product | Active ingredients | Holder | Status | DIN |
|---|---|---|---|---|
| ADACEL-POLIO | POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) : 29 UNIT / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 5 MCG / 0.5 ML DIPHTHERIA TOXOID : 2 LF / 0.5 ML PERTUSSIS TOXOID : 2.5 MCG / 0.5 ML TETANUS TOXOID : 5 LF / 0.5 ML POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) : 7 UNIT / 0.5 ML POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) : 26 UNIT / 0.5 ML FIMBRIAE TYPES 2 AND 3 (FIM) : 5 MCG / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML | SANOFI PASTEUR LIMITED | MARKETED | 02352044 |
| INFANRIX-IPV/HIB | FILAMENTOUS HAEMAGGLUTININ : 25 MCG / 0.5 ML HAEMOPHILUS INFLUENZAE TYPE B-PRP AND TETANUS TOXOID CONJUGATE (PRP-T) : 10 MCG / 0.5 ML INACTIVATED POLIOVIRUS TYPE II : 8 UNIT / 0.5 ML PERTUSSIS TOXOID : 25 MCG / 0.5 ML DIPHTHERIA TOXOID : 30 UNIT / 0.5 ML INACTIVATED POLIOVIRUS TYPE III : 32 UNIT / 0.5 ML TETANUS TOXOID : 40 UNIT / 0.5 ML PERTACTIN : 8 MCG / 0.5 ML INACTIVATED POLIOVIRUS TYPE I : 40 UNIT / 0.5 ML | GLAXOSMITHKLINE INC | MARKETED | 02257122 |
| QUADRACEL | TETANUS TOXOID : 5 LF / 0.5 ML FIMBRIAE TYPES 2 AND 3 (FIM) : 5 MCG / 0.5 ML POLIOVIRUS TYPE 1 MAHONEY (INACTIVATED) : 29 UNIT / 0.5 ML PERTACTIN : 3 MCG / 0.5 ML DIPHTHERIA TOXOID : 15 LF / 0.5 ML POLIOVIRUS TYPE 2 MEF1 (INACTIVATED) : 7 UNIT / 0.5 ML POLIOVIRUS TYPE 3 SAUKETT (INACTIVATED) : 26 UNIT / 0.5 ML PERTUSSIS TOXOID : 20 MCG / 0.5 ML FILAMENTOUS HAEMAGGLUTININ : 20 MCG / 0.5 ML | SANOFI PASTEUR LIMITED | MARKETED | 02534789 |
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.
Can this still be bought in Canada?
No. This Drug Identification Number is cancelled post market in Health Canada's Drug Product Database, so the product is no longer authorized for sale in Canada and Nexara does not supply it. This page is kept as a regulatory record.
If you are looking for a current equivalent, the alternatives above list every product sharing this therapeutic class, with the marketed ones first. Ask us to source an alternative
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.