ADVIL COLD & SINUS PLUS 30 MG — DIN 02248645
PSEUDOEPHEDRINE HYDROCHLORIDE : 30 MG CHLORPHENIRAMINE MALEATE : 2 MG IBUPROFEN : 200 MG · HALEON CANADA ULC · TABLET · wholesale supply in Canada
Health Canada status: MARKETED
What is ADVIL COLD & SINUS PLUS?
ADVIL COLD & SINUS PLUS 30 MG contains PSEUDOEPHEDRINE HYDROCHLORIDE : 30 MG CHLORPHENIRAMINE MALEATE : 2 MG IBUPROFEN : 200 MG. It is listed in the Health Canada Drug Product Database under DIN 02248645, held by HALEON CANADA ULC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 14-Jul-2026. 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.
Is there a generic Ibuprofen, Combinations 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.
9 holders have a Canadian DIN containing Ibuprofen, Combinations, across 40 DINs, of which 13 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 |
|---|---|---|---|---|
| GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC | 11 | 5 | ADVIL COLD & FLU, ADVIL COLD & SINUS CONVENIENCE PACK, ADVIL COLD & SINUS EXTRA STRENGTH LIQUI-GELS, ADVIL COLD & SINUS LIQUI-GELS, ADVIL COLD & SINUS PE, ADVIL COLD AND SINUS, ADVIL COLD AND SINUS DAYTIME, ADVIL DAY/NIGHT CONVENIENCE PACK, ADVIL NIGHTTIME, ADVIL PAIN & HEAD COLD NIGHT, CHILDREN'S ADVIL COLD | Sourceable in Canada |
| HALEON CANADA ULC | 5 | 4 | ADVIL COLD & SINUS PLUS, ADVIL COLD AND SINUS NIGHTTIME, ADVIL COLD, SINUS & FLU EXTRA STRENGTH, ADVIL FLU, CHILDREN'S ADVIL COLD & FLU MULTI-SYMPTOM | Sourceable in Canada |
| VITA HEALTH PRODUCTS INC | 8 | 3 | COLD + SINUS, COLD + SINUS CAPLETS, COLD + SINUS DAYTIME, COLD + SINUS DAYTIME COLD + SINUS NIGHTTIME, COLD + SINUS NIGHTTIME, COLD + SINUS PLUS, IBUPROFEN DAYTIME, IBUPROFEN NIGHTTIME, IBUPROFEN NIGHTTIME | Sourceable in Canada |
| MCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC | 5 | 1 | CHILDREN'S MOTRIN COLD, IBUPROFEN AND PSEUDOEPHEDRINE, MOTRIN COLD & SINUS CAPLETS, MOTRIN COLD & SINUS PAIN, SUDAFED SINUS ADVANCE | Sourceable in Canada |
| APOTEX INC | 3 | 0 | COLD & SINUS RELIEF CAPSULES, NIGHTTIME COLD, COUGH & FLU, NIGHTTIME PAIN RELIEF | No marketed DIN |
| MARCAN PHARMACEUTICALS INC | 3 | 0 | COLD AND SINUS PLUS, IBUPROFEN + PSEUDOEPHEDRINE CAPLETS, NIGHTTIME PAIN RELIEVER | No marketed DIN |
| CATALENT ONTARIO LIMITED | 2 | 0 | IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULES | No marketed DIN |
| WHITEHALL-ROBINS INC. | 2 | 0 | DIMETAPP COLD AND SINUS CAPLETS, DRISTAN SINUS CAPLETS | No marketed DIN |
| PROCTER & GAMBLE INC | 1 | 0 | VICKS DAYQUIL SINUS PR.AND PAIN REL.W.IBUPR. | 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 | 30 MG |
|---|---|
| Dosage form | TABLET |
| Route | ORAL |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Substance and classification
| Active substance | Ibuprofen, Combinations |
|---|---|
| ATC code | M01AE51 |
| AHFS class | 28:08.04.92 ; 04:04.20 |
| 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) | 02248645 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2248645 |
| Brand name | ADVIL COLD & SINUS PLUS |
| Generic / active ingredient | PSEUDOEPHEDRINE HYDROCHLORIDE : 30 MG CHLORPHENIRAMINE MALEATE : 2 MG IBUPROFEN : 200 MG |
| Market authorization holder | HALEON CANADA ULC |
| Health Canada schedule | NON-PRESCRIPTION DRUGS |
| ATC code | M01AE51 |
| ATC anatomical main group | M — Musculo-skeletal system |
| ATC therapeutic subgroup | M01AE |
| Current status | MARKETED |
| Status date | 14-Jul-2026 |
| Original market date | 2004-08-02 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
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
13 of 40 Canadian DINs for this molecule are currently marketed. Marketed products are listed first.
| Product | Strength | Form | Holder | Health Canada status | DIN |
|---|---|---|---|---|---|
| ADVIL COLD & SINUS CONVENIENCE PACK | 2 MG | KIT ; TABLET | GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC | MARKETED | 02399733 |
| ADVIL COLD & SINUS LIQUI-GELS | 200 MG | CAPSULE | GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC | MARKETED | 02250705 |
| ADVIL COLD AND SINUS | 200 MG | TABLET | GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC | MARKETED | 02036312 |
| ADVIL COLD AND SINUS DAYTIME | 200 MG | TABLET | GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC | MARKETED | 02267616 |
| ADVIL COLD AND SINUS NIGHTTIME | 30 MG | TABLET | HALEON CANADA ULC | MARKETED | 02267632 |
| ADVIL COLD, SINUS & FLU EXTRA STRENGTH | 4 MG | TABLET | HALEON CANADA ULC | MARKETED | 02471604 |
| ADVIL FLU | 200 MG | CAPSULE | HALEON CANADA ULC | MARKETED | 02401193 |
| ADVIL NIGHTTIME | 200 MG | CAPSULE | GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC | MARKETED | 02355841 |
| COLD + SINUS | 200 MG | TABLET | VITA HEALTH PRODUCTS INC | MARKETED | 02352281 |
| COLD + SINUS DAYTIME COLD + SINUS NIGHTTIME | 30 MG | TABLET ; KIT | VITA HEALTH PRODUCTS INC | MARKETED | 02388030 |
2 · Same class — other molecules in ATC M01AE
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Ibuprofen | ACTIPROFEN - CAPLET 200MG · ADVIL 12 HOUR · ADVIL ARTHRITIS PAIN · ADVIL CAPLETS · ADVIL EXTRA STRENGTH CAPLETS · ADVIL EXTRA STRENGTH LIQUI-GELS · ADVIL GEL CAPLETS · ADVIL HEADACHE & MIGRAINE CAPLETS · ADVIL HEADACHE & MIGRAINE EXTRA STRENGTH · ADVIL HEADACHE & MIGRAINE PAIN CAPLETS · ADVIL HEADACHE & MIGRAINE PAIN EXTRA STRENGTH CAPLETS · ADVIL HEADACHE & MIGRAINE PAIN TABLETS · ADVIL HEADACHE & MIGRAINE TABLETS · ADVIL HEADACHE CAPLETS · ADVIL HEADACHE EXTRA STRENGTH · ADVIL HEADACHE TABLETS · ADVIL LIQUI-GELS · ADVIL MIGRAINE & HEADACHE · ADVIL MIGRAINE CAPLETS · ADVIL MIGRAINE EXTRA STRENGTH · ADVIL MIGRAINE TABLETS · ADVIL MINI-GELS · ADVIL MUSCLE AND JOINT · ADVIL PEDIATRIC DROPS · ADVIL PEDIATRIC DROPS FEVER FROM COLDS OR FLU · ADVIL TABLETS · ALTI-IBUPROFEN TAB 300MG · ALTI-IBUPROFEN TAB 400MG · ALTI-IBUPROFEN TAB 600MG · APO-IBUPROFEN · APO-IBUPROFEN CAPLET · APO-IBUPROFEN TAB 600MG · CALDOLOR · CHILDREN'S ADVIL · CHILDREN'S ADVIL CHEWABLE TABLETS · CHILDREN'S ADVIL FEVER FROM COLDS OR FLU · CHILDREN'S EUROPROFEN · CHILDREN'S IBUPROFEN SUSPENSION · CHILDREN'S MOTRIN · CHILDREN'S MOTRIN CHEWABLE TABLET 50MG · CHILDREN'S MOTRIN CHEWABLE TABLETS · EXTRA STRENGTH IBUPROFEN · EXTRA STRENGTH IBUPROFEN LIQUID CAPSULES · EXTRA STRENGTH IBUPROFEN LIQUID FILLED CAPSULES · EXTRA STRENGTH IBUPROFEN LIQUID GEL CAPSULES · IBUPROFEN · IBUPROFEN - TAB 200MG · IBUPROFEN 200 MG · IBUPROFEN 400 MG · IBUPROFEN CAPLETS · IBUPROFEN CAPLETS 200 MG · IBUPROFEN CAPSULES 200 MG · IBUPROFEN CAPSULES, 200 MG · IBUPROFEN CAPSULES, 200MG · IBUPROFEN CAPSULES, 400 MG · IBUPROFEN CAPSULES, 400MG · IBUPROFEN DAYTIME · IBUPROFEN EXTRA STRENGTH CAPLETS · IBUPROFEN LIQUID CAPSULES · IBUPROFEN LIQUID FILLED CAPSULES · IBUPROFEN LIQUID GEL · IBUPROFEN LIQUID GEL CAPSULES · IBUPROFEN LIQUID GELS · IBUPROFEN MENSTRUAL PAIN RELIEF · IBUPROFEN MINI LIQUID CAPSULES · IBUPROFEN MUSCLE AND JOINT · IBUPROFEN ORAL SUSPENSION USP · IBUPROFEN ORAL SUSPENSION, 100 MG / 5 ML · IBUPROFEN TAB 200MG · IBUPROFEN TAB 300MG · IBUPROFEN TAB 400MG · IBUPROFEN TABLETS · IBUPROFEN TABLETS 200 MG · IBUPROFEN-600 TAB 600MG · INFANTS' MOTRIN · JAMP IBUPROFEN SUSPENSION · JAMP-IBUPROFEN · JUNIOR STRENGTH ADVIL · JUNIOR STRENGTH ADVIL FEVER FROM COLDS OR FLU · JUNIOR STRENGTH MOTRIN CAPLETS · JUNIOR STRENGTH MOTRIN CHEWABLE TABLET 100MG · JUNIOR STRENGTH MOTRIN CHEWABLE TABLETS · MEDIPREN TAB 200MG · MOTRIN 200MG · MOTRIN 300MG · MOTRIN 400MG · MOTRIN CAPLET · MOTRIN GELCAPS · MOTRIN IB CAPLET/TAB 200MG · MOTRIN IB CAPLETS 200MG · MOTRIN IB MENSTRUAL PAIN · MOTRIN LIQUID GELS 200MG · MOTRIN LIQUID GELS 400 MG · MOTRIN TABLETS 300MG · MOTRIN TABLETS 400MG · MOTRIN TABLETS 600MG · MUSCLE & JOINT · NOVO-PROFEN · NU-IBUPROFEN TAB 300MG · NU-IBUPROFEN TAB 400MG · NU-IBUPROFEN TAB 600MG · PAMPRIN IBUPROFEN FORMULA · PENDO-IBUPROFEN · PENDO-IBUPROFEN (200MG CAPLET) · PENDO-IBUPROFEN ES · PMS-IBUPROFEN · PMS-IBUPROFEN (CAPLETS) · REGULAR IBUPROFEN · SUPER STRENGTH MOTRIN IB LIQUID GELS · SUPER STRENGTH MOTRIN IB MENSTRUAL PAIN · TEVA-PROFEN | 143 | 46 | Yes |
| Naproxen | ALEVE BACK AND BODY PAIN · ALEVE CAPLETS · ALEVE LIQUID GELS · ALEVE NIGHTTIME · ANAPROX · ANAPROX DS · ANAPROX DS TAB 550MG · APO NAPROXEN TAB 125MG · APO-NAPRO-NA · APO-NAPRO-NA DS · APO-NAPROXEN · APO-NAPROXEN EC · APO-NAPROXEN EC TABLETS · APO-NAPROXEN SR TABLETS 750MG · AVA-NAPROXEN EC · MAXIDOL LIQUID GELS · MOTRIMAX 12 HOUR · MOTRIMAX 12 HOUR TABLETS · MYLAN-NAPROXEN EC · NAPRELAN · NAPROSYN · NAPROSYN 250MG · NAPROSYN 250MG TABLETS · NAPROSYN 375MG · NAPROSYN 375MG TABLETS · NAPROSYN 500 MG SUPPOSITORIES · NAPROSYN 500 MG TABLETS · NAPROSYN E 250MG TABLETS - ECT · NAPROSYN E TAB 250MG · NAPROSYN E TAB 375MG · NAPROSYN E TAB 500MG · NAPROSYN SUP 500MG · NAPROSYN SUS 25MG/ML · NAPROSYN-SR TAB 750MG · NAPROXEN · NAPROXEN - 250 · NAPROXEN - 500 · NAPROXEN 125 TAB 125MG · NAPROXEN CAPSULES 200 MG · NAPROXEN EC · NAPROXEN LIQUID GELS · NAPROXEN MENSTRUAL PAIN RELIEF · NAPROXEN SODIUM · NAPROXEN SODIUM CAPLETS · NAPROXEN SODIUM CAPSULES · NAPROXEN SODIUM DS · NAPROXEN SODIUM TABLETS · NAPROXEN-375 · NAPROXEN-NA · NAPROXEN-NA DF · NOVO-NAPROX TAB 125MG · NTP-NAPROXEN · NTP-NAPROXEN EC · NTP-NAPROXEN SODIUM · NTP-NAPROXEN SODIUM DS · NU-NAPRO-NA · NU-NAPRO-NA DS · NU-NAPROX EC · NU-NAPROX TAB 125MG · NU-NAPROX TAB 250MG · NU-NAPROX TAB 375MG · NU-NAPROX TAB 500MG · NX 12 HOUR · PEDIAPHARM NAPROXEN SUSPENSION · PMS-NAPROXEN · PMS-NAPROXEN EC · PRO-NAPROXEN EC · PRO-NAPROXEN EC - 375 · RATIO-NAPROXEN · RATIO-NAPROXEN E · RHODIAPROX - 500MG/SUP · RIVA-NAPROXEN · RIVA-NAPROXEN SODIUM · RIVA-NAPROXEN SODIUM DS · SAB-NAPROXEN · SYNFLEX DS TAB 550MG · SYNFLEX TAB 275MG · TEVA-NAPROXEN · TEVA-NAPROXEN EC · TEVA-NAPROXEN SODIUM · TEVA-NAPROXEN SODIUM DS · TEVA-NAPROXEN SR · WAYMADE-NAPROXEN · WAYMADE-NAPROXEN SODIUM · WAYMADE-NAPROXEN SODIUM DS | 125 | 31 | Yes |
| Ibuprofen, Combinations | ADVIL COLD & FLU · ADVIL COLD & SINUS CONVENIENCE PACK · ADVIL COLD & SINUS EXTRA STRENGTH LIQUI-GELS · ADVIL COLD & SINUS LIQUI-GELS · ADVIL COLD & SINUS PE · ADVIL COLD & SINUS PLUS · ADVIL COLD AND SINUS · ADVIL COLD AND SINUS DAYTIME · ADVIL COLD AND SINUS NIGHTTIME · ADVIL COLD, SINUS & FLU EXTRA STRENGTH · ADVIL DAY/NIGHT CONVENIENCE PACK · ADVIL FLU · ADVIL NIGHTTIME · ADVIL PAIN & HEAD COLD NIGHT · CHILDREN'S ADVIL COLD · CHILDREN'S ADVIL COLD & FLU MULTI-SYMPTOM · CHILDREN'S MOTRIN COLD · COLD & SINUS RELIEF CAPSULES · COLD + SINUS · COLD + SINUS CAPLETS · COLD + SINUS DAYTIME · COLD + SINUS DAYTIME COLD + SINUS NIGHTTIME · COLD + SINUS NIGHTTIME · COLD + SINUS PLUS · COLD AND SINUS PLUS · DIMETAPP COLD AND SINUS CAPLETS · DRISTAN SINUS CAPLETS · IBUPROFEN + PSEUDOEPHEDRINE CAPLETS · IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES · IBUPROFEN AND PSEUDOEPHEDRINE · IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULES · IBUPROFEN DAYTIME, IBUPROFEN NIGHTTIME · IBUPROFEN NIGHTTIME · MOTRIN COLD & SINUS CAPLETS · MOTRIN COLD & SINUS PAIN · NIGHTTIME COLD, COUGH & FLU · NIGHTTIME PAIN RELIEF · NIGHTTIME PAIN RELIEVER · SUDAFED SINUS ADVANCE · VICKS DAYQUIL SINUS PR.AND PAIN REL.W.IBUPR. | 40 | 13 | Yes |
| Naproxen And Esomeprazole | MYLAN-NAPROXEN/ESOMEPRAZOLE MR · VIMOVO | 4 | 4 | Yes |
| Ketoprofen | KETOPROFEN · KETOPROFEN SR · KETOPROFEN SUPPOSITORIES · KETOPROFEN-E · KETOPROFEN-E ECT 100MG · KETOPROFEN-E ECT 50MG · KETOPROFEN-SR - SRT 200MG · NOVO-KETO SUPPOSITORIES 100MG · NOVO-KETO-EC TAB 100MG · NOVO-KETO-EC TAB 50MG · NU-KETOPROFEN CAP 50MG · NU-KETOPROFEN-E ECT 100MG · NU-KETOPROFEN-E ECT 50MG · ORAFEN - SUP RT 100MG · ORUDIS 100 · ORUDIS 50 · ORUDIS CAP 50MG · ORUDIS E-100 · ORUDIS E-50 · ORUDIS SR-200 · ORUVAIL 150 · ORUVAIL 200 · PMS-KETOPROFEN · PMS-KETOPROFEN CAPSULES · PMS-KETOPROFEN E-100 - ECT · PMS-KETOPROFEN E-50 - ECT 50MG · RHODIS · RHODIS CAP 50MG · RHODIS EC · RHODIS SR 200MG · RHOVAIL 150 · RHOVAIL 200 | 36 | 3 | Yes |
| Tiaprofenic Acid | ALBERT TIAFEN SR · ALBERT TIAFEN TAB 200MG · ALBERT TIAFEN TAB 300MG · APO-TIAPROFENIC TABLETS -300MG · APO-TIAPROFENIC TABLETS-200MG · DOM-TIAPROFENIC · NU-TIAPROFENIC - TAB 200MG · NU-TIAPROFENIC - TAB 300MG · PENTA-TIAPROFENIC TABLETS · PMS-TIAPROFENIC · SURGAM · SURGAM SR · SURGAM SR CAP 300MG · SURGAM TAB 200MG · SURGAM TAB 300MG · SURGAM-SR SRC 300MG · TEVA-TIAPROFENIC ACID · TIAPROFENIC-200 - TAB · TIAPROFENIC-300 - TAB | 25 | 2 | Yes |
| Flurbiprofen | ANSAID TABLETS 100 MG · ANSAID TABLETS 50 MG · FLURBIPROFEN · FLURBIPROFEN-100 TAB 100MG · FLURBIPROFEN-50 TAB 50MG · FROBEN · FROBEN SR · FROBEN TAB 100MG · FROBEN TAB 50MG · FROBEN-SR CAP 200MG · NOVO-FLURPROFEN SR · NU-FLURBIPROFEN TAB 100MG · NU-FLURBIPROFEN TAB 50MG · RATIO-FLURBIPROFEN TABLETS 100MG · RATIO-FLURBIPROFEN TABLETS 50MG · TEVA-FLURBIPROFEN | 19 | 2 | Yes |
| Oxaprozin | APO-OXAPROZIN · DAYPRO · RHOXAL-OXAPROZIN | 3 | 0 | Not in Canada |
| Fenoprofen | NALFON CAP 300MG · NALFON TAB 600MG | 2 | 0 | Not in Canada |
| Naproxen And Diphenhydramine | PAIN RELIEVER & SLEEP AID | 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 M01A
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| M01AB | Diclofenac · Diclofenac, Combinations · Etodolac · Indometacin · Ketorolac · Sulindac · Tolmetin | 170 | 38 |
| M01AH | Celecoxib · Rofecoxib | 72 | 30 |
| M01AC | Meloxicam · Piroxicam · Tenoxicam | 67 | 14 |
| M01AG | Mefenamic Acid | 7 | 1 |
| M01AX | Nabumetone | 12 | 1 |
| M01AA | Oxyphenbutazone · Phenylbutazone · Phenylbutazone, Combinations | 7 | 0 |
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.