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NUTRINEAL PD4 DIN 02230810

Status: Cancelled Post Market
Holder: BAXTER CORPORATION
Molecule: VALINE

Health Canada record

Active ingredient(s)VALINE 139.3 MG; LEUCINE 102 MG; ISOLEUCINE 85 MG; DL-METHIONINE 85 MG; LYSINE (LYSINE MONOHYDROCHLORIDE) 95.5 MG; HISTIDINE 71.4 MG; THREONINE 64.6 MG; PHENYLALANINE 57 MG; TRYPTOPHAN 27 MG; ARGININE 107.1 MG; ALANINE 95.1 MG; PROLINE 59.5 MG; GLYCINE 51 MG; SERINE 51 MG; TYROSINE 30 MG; SODIUM CHLORIDE 538 MG; SODIUM LACTATE 448 MG; CALCIUM CHLORIDE 18.4 MG; MAGNESIUM CHLORIDE 5.1 MG
Dosage formLiquid
RouteHaemodialysis
ScheduleETHICAL
ClassHuman
ATCB05ZA HEMODIALYTICS, CONCENTRATES
Original market date25-Sep-1998
Current status date02-Nov-2021
SourceHealth Canada DPD

Establishment licence of the holder

Baxter Corporation — licence 100278, currently licensed, last inspection rating C (2026-08-11).

No Canadian shortage report is currently matched to this DIN.

Other Canadian products containing VALINE

DINProductCompanyFormStrengthStatus
0214145020% PROSOLBAXTER CORPORATIONLiquidVALINE 1.44 G; LYSINE (LYSINE ACETATE) 1.35 G; HISTIDINE 1.18 G; ISOLEUCINE 1.08 G; LEUCINE 1.08 G; PHENYLALANINE 1 G; THREONINE 0.98 G; DL-METHIONINE 0.76 G; TRYPTOPHAN 0.32 G; ALANINE 2.76 G; GLYCINE 2.06 G; ARGININE 1.96 G; PROLINE 1.34 G; GLUTAMIC ACID 1.02 G; SERINE 1.02 G; L-ASPARTIC ACID 0.6 G; TYROSINE 0.05 GMarketed

Notices of Compliance

NOCDateSubmissionReason
32751997-02-27New Drug Submission (NDS)

International API supply for VALINE

7 valid EDQM Certificates of Suitability from 7 holders. 5 active FDA Drug Master Files.

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