First report 16 Aug 2019•Latest report 16 Aug 2019
Recipient record
Reports, concerns and published responses
Private and voluntary organisations · Private limited company. This page brings together reports naming this recipient and response statements clearly connected to concerns raised in those reports.
Reports
1
Naming this recipient
Published responses
100%
Found for named reports
Concerns addressed
4
Across all linked responses
Stated actions
7
Described in responses
Reports over time
Reports over time
Reports naming this recipient by issue year.
Evidence profile
Report topics
Share of this recipient’s reports compared with all other recipients.
100%published responses found
7stated actions described
Topic comparisons are not available in the current evidence snapshot.
Concerns and recipient responses
Statements from Boehringer Ingelheim Limited linked to the concerns in each report. Select any concern, action or position to view the source wording.
Addressed to: Mr Uday Bose, Chief Executive, Boehringer Ingelheim Limited.
West Sussex
Concerns raised4
Lack of bottle warnings about unmeasured or excessive dosing
Failure to counsel medication users on the use and risks of exceeding the prescribed dose
Unmeasured dosing from the medication bottle
Insufficient leaflet warnings about taking an excess dose
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response An action is something this recipient says it has done, is doing, or plans to do in response to the concern raised.2
Action
Request MHRA approval to strengthen and embolden the prescriber-direction warning on the Oramorph bottle label.
Stated plannedThe respondent said that this action was planned when they made their response on 18 October 2019.
Action
Request MHRA approval to add an explicit warning against drinking Oramorph directly from the bottle and describe overdose risks in the patient information leaflet.
Stated plannedThe respondent said that this action was planned when they made their response on 18 October 2019.
Respondent positions A position is what this recipient says about the concern when it does not describe a specific action.5
Position
Existing dosing instructions and approved labelling were considered sufficiently clear despite lacking an explicit warning against drinking directly from the bottle.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Position
Proposed changes to the leaflet, bottle label, and carton require review and approval by the MHRA and HPRA.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Position
The existing Patient Information Leaflet sufficiently warns about excess-dose symptoms, risks, required medical help, and possible death, so no further action was taken.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Position
Existing bottle and carton wording was considered sufficiently clear and compliant with statutory requirements, despite a proposal to strengthen and emphasise it.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
Position
Prescribing clinicians and other healthcare professionals are responsible for explaining dosing, risks, and consequences of exceeding prescribed doses.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
Includes reports addressed to a minister or senior office-holder acting for this organisation.
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Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations