Active substance
Macrogol 4000
- UK MHRA 2
- Safety 1
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| DULCOBALANCE 10G, POWDER FOR ORAL SOLUTION IN SACHET | PL 51419/0001 | MAYOLY PHARMA FRANCE | P |
| PEGLAX 10 G POWDER FOR ORAL SOLUTION IN SACHET | PL 43885/0006 | CASEN RECORDATI SL | P |
Safety signals and safety-related labeling changes
- EMA PRAC 13 Feb 2020 PRAC signal: Colitis ischaemic
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.