Active substance
Lenograstim
- UK MHRA 1
- Safety 5
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| GRANOCYTE 13 MILLION IU/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION IN A PFS | PL 12185/0002 | CHUGAI PHARMA UK LIMITED | POM |
Safety signals and safety-related labeling changes
- EMA PRAC 17 May 2018 PRAC signal: Pulmonary haemorrhage
Action for MAH: update of the product information: Yes - EMA PRAC 8 Feb 2018 PRAC signal: Aortitis
Action for MAH: update of the product information: Yes - EMA PRAC 1 Sep 2017 PRAC signal: Aortitis
Action for MAH: update of the product information: No - EMA PRAC 7 Nov 2013 PRAC signal: (Systemic) capillary leak syndrome (CLS)
Action for MAH: update of the product information: Yes - EMA PRAC 13 Jun 2013 PRAC signal: (Systemic) capillary leak syndrome (CLS)
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.