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Daiichi Sankyo: European observational study SANTORINI shows LDL-C levels remain higher than recommended goals and combination therapies are under-utilised in patients at very high or high cardiovascular risk

Daiichi Sankyo: European observational study SANTORINI shows LDL-C levels remain higher than recommended goals and combination therapies are under-utilised in patients at very high or high cardiovascular risk
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Novartis products will remain available despite Brexit

Novartis products will remain available at all pharmacies despite the UK no longer being part of the EU single market for pharmaceuticals, the company’s r

Malta , Ireland , United-kingdom , Cyprus , Mario-debono , Salomone-pharma , Tania-borg , Novartis-europharm-ltd , Medium-enterprises , Novartis-pharma-services-inc , Novartis , Marketing-authorisations

Parallel submission of generic applications

Parallel submission of generic applications
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Interim Statement by the Malta Medicines Authority on AstraZeneca COVID-19 Vaccine (Vaxzevria)

Interim Statement by the Malta Medicines Authority on AstraZeneca COVID-19 Vaccine (Vaxzevria)
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Marketing authorisations for veterinary medicines

Marketing authorisations for veterinary medicines
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Joint labelling for veterinary medicines for use in the UK and Ireland


Joint labelling for veterinary medicines for use in the UK and Ireland
Guidance for the veterinary pharmaceutical industry on how to apply for and maintain a joint-label for use on veterinary medicines placed on the market in the UK and Ireland.
From:
Eligible Marketing Authorisations and criteria
Joint-labelling allows for a single label/leaflet that has been agreed by the VMD, on behalf of the UK, and the Health Products Regulatory Authority (
HPRA), on behalf of Ireland, for use on veterinary medicines marketed in their countries.
Joint labelling could be achieved between GB and IE, NI and IE or all three - GB, IE and NI. You should also refer to the

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Class 3 Medicines Recall: SyriMed, Clonidine hydrochloride 50micrograms/5ml Oral Solution, EL (21)A/05


Brief description of the problem
SyriMed are recalling the above batch as a precautionary measure due to an issue related to the container closure (child-lock cap). The Marketing Authorisation Holder has received a number of complaints related to defective container closures and the investigation has identified an issue with the bottle capping during the manufacturing process for this batch only.
Advice for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Further Information
For more information or medical information queries, please contact: customer.services@syrimed.co.uk.

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Register to make submissions to the MHRA


Register to make submissions to the MHRA
Submissions related to human medicines need to be submitted directly to the MHRA.
From:
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For applications that you plan to submit to the UK (for example, a Marketing Authorisation for the UK or GB market), you will need to submit the information through our national portals. For those regulatory submissions made through European procedures you will need to continue to submit via the EU portals (for example, CESP).
The information on how to make submissions to the MHRA is for the following groups:
all pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities for UK/GB licences

United-kingdom , Northern-ireland , Craigavon , Britain , European-medicines-agency , Customer-services-centre , Microsoft , Marketing-authorisation , Initial-applications , Substantial-amendments , Trial-notifications

Registering to make submissions to the MHRA from 1 January 2021

Registering to make submissions to the MHRA from 1 January 2021
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