Active substance
Insulin porcine
- UK MHRA 9
- Safety 5
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| BIPHASIC ISOPHANE INSULIN INJECTION BP (PORCINE) | PL 29831/0119 | WOCKHARDT UK LIMITED | POM |
| HYPURIN PORCINE 30/70 MIX | PL 29831/0118 | WOCKHARDT UK LIMITED | POM |
| HYPURIN PORCINE 30/70 MIX | PL 29831/0119 | WOCKHARDT UK LIMITED | POM |
| HYPURIN PORCINE ISOPHANE | PL 29831/0121 | WOCKHARDT UK LIMITED | POM |
| HYPURIN PORCINE ISOPHANE | PL 29831/0122 | WOCKHARDT UK LIMITED | POM |
| HYPURIN PORCINE NEUTRAL | PL 29831/0124 | WOCKHARDT UK LIMITED | POM |
| HYPURIN PORCINE NEUTRAL | PL 29831/0126 | WOCKHARDT UK LIMITED | POM |
| ISOPHANE INSULIN INJECTION BP (PORCINE) | PL 29831/0122 | WOCKHARDT UK LIMITED | POM |
| NEUTRAL INSULIN INJECTION BP (PORCINE) | PL 29831/0124 | WOCKHARDT UK LIMITED | POM |
Safety signals and safety-related labeling changes
- EMA PRAC 17 Apr 2020 PRAC signal: Cutaneous amyloidosis
Action for MAH: update of the product information: Yes - EMA PRAC 28 Nov 2019 PRAC signal: Cutaneous amyloidosis
Action for MAH: update of the product information: No - EMA PRAC 30 Nov 2017 PRAC signal: Potential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia
Action for MAH: update of the product information: Yes - EMA PRAC 29 Sep 2017 PRAC signal: Potential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia
Action for MAH: update of the product information: No - EMA PRAC 5 May 2017 PRAC signal: Potential increased risk of medication error associated with pre-filled pens and cartridges presentations, leading to inadequate diabetes control
Action for MAH: update of the product information: Yes
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.