Title:
Marketing Authorization Granted in Oct 2014
Summary
Details of marketing authorisations (MAs) granted in October 2014.
To Download the List CLICK BELOW LINK
Showing posts with label MHRA. Show all posts
Showing posts with label MHRA. Show all posts
MHRA Monthly list of granted marketing authorisations: Marketing authorisations granted in October 2014
Marketing Authorization Granted in Oct 2014
Summary
MHRA : Company-led drug alert: Recivit Sublingual Tablets - Grünenthal Limited - CLDA (14)A/19...
Company-led recalls 18 November 2014
CLDA number: CLDA (14)A/19
MDR number: MDR 25-11/14
Company name: Grünenthal Limited
Product description:
Recivit Sublingual Tablets:
133mcg PL 21727/0058
267mcg PL 21727/0059
400mcg PL 21727/0060
533mcg PL 21727/0061
800mcg PL 21727/0062
133mcg PL 21727/0058
267mcg PL 21727/0059
400mcg PL 21727/0060
533mcg PL 21727/0061
800mcg PL 21727/0062
Batch number/ Expiry:
- 133mcg: batch no 14628; exp 30/09/2016
- 267mcg: batch no 14630; exp 31/10/2016
- 400mcg: batch no 14632; exp 31/10/2016
- 533mcg: batch no 15025; exp 31/10/2016
- 800mcg: batch no 14636; exp 30/11/2016
Brief description of problem:
Due to a manufacturing issue, there is a possibility that blisters
from the above batches may contain missing and / or two tablets in a
single blister cavity.
We understand that a very small number of packs from the affected batches have been distributed to the UK market.
We understand that a very small number of packs from the affected batches have been distributed to the UK market.
Company contact for stock enquiries:
UDG customer service
Tel 01773 515171
Tel 01773 515171
Company contact for medical information enquiries:
Grünenthal Medical Information
Tel 0870 351 8960
Email: medicalinformationuk@grunenthal.com
Tel 0870 351 8960
Email: medicalinformationuk@grunenthal.com
MHRA Medicine Recall Alert : Zovirax Eye Ointment manufactured by The Welcome Foundation Limited trading as GlaxoSmithKline UK
Class 2 medicines recall
Action Within 48 Hours
Pharmacy and Wholesaler Level Recall
The Welcome Foundation Limited trading as GlaxoSmithKline UK
Zovirax Eye Ointment (Aciclovir 3%)
PL 0003/0150
Batch No.: 3L942 (Exp. Date Oct 2018, Pack Size: 4.5G, First Distributed 10JAN2014)
Batch No.: 3M941 (Exp. Date Jan 2019, Pack Size: 4.5G, First Distributed 07APR2014)
GlaxoSmithKline UK is recalling the below mentioned batches of Zovirax Eye
Ointment as a precaution because the batches of pharmaceutical
ingredient used in their manufacture were found to contain metal
particles which were outside the upper specification limit for particle
size. No complaints or adverse reaction reports relating to this issue
have been received by the company to date.
Remaining stocks of the above batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock return please contact your original supplier.
There are no alternative batches of this product currently available and we understand that shortages are already being reported. Please find attached a copy of a Memo from UK Medical information (UKMI)
advising on the availability of alternative therapies for the treatment of herpes simplex keratitis.
For more details CLICK HERE
MHRA Press Release : Professor Sir Michael Rawlins appointed Chair of MHRA
The MHRA announced
the appointment of Professor Sir Michael Rawlins as its new Chair. He
will take charge from 01 Dec 2014 for 3 years.
Professor Sir Michael will take over from Sir Gordon Duff who announced
his intention to step down earlier this year, following his election as
Principal of St Hilda’s College, Oxford.
Professor Sir Michael Rawlins was until recently Chair of the National Institute of Health & Clinical Excellence (NICE), a role from which he stood down in 2013. He is also currently Chairman of Biobank.
For details CLICK HERE
MHRA Medicines watchdog makes record seizure of experimental smart drugs...
MHRA today
announced the UK’s biggest ever single seizure of smart drugs, also
known as cognitive enhancers or nootropics. With over 20,000 units, of
13 different types of cognitive enhancement medicines. The seizure
represents an approximate value of £200,000.
The raid saw seizures of a large range of cognitive enhancers including noopept, phenylpiracetam, centrophenoxine, oxiracetam, sunifiram, citicoline and aniracetam, and illustrated the burgeoning demand and variety of new active substances entering the marketplace. The seizure also highlighted concerns around the increasing experimentation amongst users. One of the products seized, Sunifiram has never been tested or been subject to clinical trials involving humans.
The raid saw seizures of a large range of cognitive enhancers including noopept, phenylpiracetam, centrophenoxine, oxiracetam, sunifiram, citicoline and aniracetam, and illustrated the burgeoning demand and variety of new active substances entering the marketplace. The seizure also highlighted concerns around the increasing experimentation amongst users. One of the products seized, Sunifiram has never been tested or been subject to clinical trials involving humans.
The seizure came following intelligence from the Norwegian Medicines
Agency after a number of packages were detained by Norwegian customs. A
full investigation was initiated after a UK source was identified and
found to be selling the unlicensed Russian cognitive enhancement drug
phenylpiracetam. This raid represents a concerted effort to crack down
on the growing trend of unlicensed online smart drug retailers.
While it is not illegal to possess these medicines, sale and supply of a prescription only or unlicensed medicine is an offence in this country.
While it is not illegal to possess these medicines, sale and supply of a prescription only or unlicensed medicine is an offence in this country.
For more information on the seizure please CLICK HERE
MHRA Medical Device Alert : Babytherm infant warmers and open infant care units for newborns manufactured by Draeger Medical...
Babytherm infant warmers and open infant care units for newborns.
Manufactured by Draeger Medical.
Model numbers: 8004, 8010 and 8000WB.
This device is an open care unit for warming premature babies, neonates and infants with a body weight of up to 8 kg.
Risk of baby falling out of the device.
Failure to follow the instructions for use for inserting the inner
safety panels and locking the outer safety side panels may result in
them opening unexpectedly.
Draeger sent a Field Safety Notice to its customers in August 2014 but hasn’t had enough replies
to know if users have received and acted upon this information.
to its customers in August 2014 but hasn’t had enough replies
to know if users have received and acted upon this information.
- Identify affected devices.
- Ensure users read the important information in the Field Safety Notice
- If the locking mechanism is not functioning, contact Draeger.
- Complete the acknowledgement sheet you received with the FSN and return it to Draeger.
Action by
All those who use these devices.MHRA : Complaints about the advertising of medicines...
We have published the results of 3 investigations into the advertising of medicines.
Cases upheld – September 2014
Complaints not upheld - September 2014
MHRA warns dentists about the dangers of buying and using Counterfeit and unapproved dental equipments...
The Medicines and Healthcare products Regulatory Agency (MHRA) is warning
dentists about the potential danger of buying and using counterfeit and
unapproved dental equipment. This follows the seizure of over 12,000
different pieces of poor quality dental equipment imported into the UK
from China and Pakistan and sold on auction websites such as eBay,
Amazon and Alibaba in the past 6 months.
The MHRA – the UK’s regulator for medical devices and medicines – has
six ongoing investigations involving the purchase of counterfeit and
unapproved dental equipment such as high-speed hand piece drills from
auction websites by UK dentists. The seized items include:
- 24 dental x-ray machines that emit high levels of radiation
- 384 hand-piece drills that could malfunction and disintegrate inside patient’s mouths
- 3,242 poor quality root canal files that could break
While there is no evidence to suggest that buying equipment from
auction websites is a widespread or deliberate practice among dentists,
the MHRA is concerned about the growing range of dental equipment that
is being advertised to dentists at cheap prices, both online and at
dental trade fairs in China.
The MHRA issued a safety alert to all dentistry professionals in
January 2014, following an incident in November 2013 when a counterfeit
product for drilling and cleaning teeth shattered while being used on a
patient. The patient was unharmed but the MHRA aims to raise awareness
among dentistry professionals so that other patients are not put at
risk.
For more details CLICK HERE
MHRA : Review of GMP Deficiency Data from Jan 2013 to Dec 2013...
MHRA recently published GMP Deficiencies during Inspections, Trend data from Jan 2013 to Dec 2013.
The report
has been presented in a revised format, following comments from a
stakeholder focus group.
In addition to 2013 inspection deficiency data, the report also
includes longer term trends in ‘top 10 deficiencies’, and highlights
areas for continued focus.
Please view/download bu clicking link below:
MHRA : ‘One stop shop’ for advice on regenerative medicine opening for business...
A new ‘one stop shop’ that will provide regulatory advice for those
working in the life sciences industry on exciting regenerative medicines
has been launched today.
The service will, for the first time, provide a single point of access to regulatory advice from the four regulatory bodies that work in the sector.
The service will help businesses and other organisations to quickly and easily navigate the different regulators and allow them to get the right advice more quickly. It will also provide a single response from the regulators and provide an opportunity for a one to one meeting.
The service will, for the first time, provide a single point of access to regulatory advice from the four regulatory bodies that work in the sector.
The service will help businesses and other organisations to quickly and easily navigate the different regulators and allow them to get the right advice more quickly. It will also provide a single response from the regulators and provide an opportunity for a one to one meeting.
Life Sciences Minister George Freeman said:
“I want to make it as easy as possible for our innovative life sciences sector to get the advice they need to turn their innovations into products that can benefit patients. Regenerative medicine is thriving and the new one stop shop highlights our commitment to ensure that the UK becomes the best place in the world for life sciences.”
The group of regulators will work together to provide cross-regulatory advice. The resource is launched today will sit within the MHRA’s Innovation Office, which already provides scientific and regulatory advice to companies developing innovative medicines and medical devices.
For Detailed Information on the MHRA "One Stop Shop" on Regenerative Medicine CLICK HERE
MHRA Drug Recall Alert - Company-led Recall of KIOVIG 100mg/ml solution for infusion, 30g/300ml - Baxter Healthcare Limited - CLDA (14)A/18
Company-led recalls: 3 October 2014
CLDA number: CLDA (14)A/18
MDR number: 06-10/14
Company name: Baxter Healthcare Limited
Product description:
KIOVIG 100mg/ml solution for infusion, 30g/300ml
Batch number/ Expiry:
- LE12P035AC Exp 01/2016
- LE12P035AE Exp 01/2016
Problem:
Baxter Healthcare Limited is recalling the above batches as a
precautionary measure due to an increased number of adverse event
reports of allergic reactions associated with these lots.
Company contact for stock enquiries:
Customer Services
Tel 01635 206330
Email: customerservicesupport@baxter.com
Company contact for medical information enquiries:
Surecall Baxter Medical Information
Tel 01635 206345
Email: surecall@baxter.com
Company contact for stock enquiries:
Customer Services
Tel 01635 206330
Email: customerservicesupport@baxter.com
Company contact for medical information enquiries:
Surecall Baxter Medical Information
Tel 01635 206345
Email: surecall@baxter.com
MHRA Simplified information requirements for advertising medicines to prescribers and suppliers, and updated Blue Guide
From 1 October 2014, companies marketing over-the-counter (OTC)
medicines will be able to use a short form of advertisement when
promoting their products to prescribers and suppliers of medicines.
This responds to a Red Tape Challenge proposal from the Proprietary
Association of Great Britain, the OTC trade association. It is designed
to reduce the number of times advertisements need to be updated when
changes are made to the Summary of Product Characteristics (SPC).
A linked change will allow a link to the SPC to be provided in an
advertisement, instead of a summary of this information. The changes are
made by regulations 24 and 29 of the Human Medicines (Amendment No. 2)
Regulations 2014.
MHRA Blue Guide, Advertising and promotion of medicines in the UK, has been
updated to reflect these changes. Detailed advice on information
requirements for advertising to prescribers and suppliers is available
in sections 6.4 and 6.5. Self-regulatory codes of practice are also
being amended to reflect these changes.
, Advertising and promotion of medicines in the UK, has been
updated to reflect these changes. Detailed advice on information
requirements for advertising to prescribers and suppliers is available
in sections 6.4 and 6.5. Self-regulatory codes of practice are also
being amended to reflect these changes.
MHRA has also taken the opportunity to make additional updates to the Blue Guide as follows:
- Updated guidance for providers offering medicinal treatment services, with new advice on advertising in social media (section 7.3 and appendix 6)
- Additional advice on prohibited gifts and benefits (section 6.14)
- Updated information about adverse drug reaction reporting (section 7.6)
- Additional clarification concerning advertising of medicines for use in pregnancy (Appendix 3)
- Updates to contact details for MHRA staff and information about NICE, ABPI and PMCPA
MHRA Drug Recall Alert : Company-led drug recall: Phenobarbital 50mg/5ml, Unlicensed Special - Nupharm Laboratories
Company-led recalls 1 October 2014
CLDA Number: CLDA (14)A/17
MDR Number: 64-09/14
Company Name: Nupharm Laboratories
Product Description: Phenobarbital 50mg/5ml, Unlicensed Special
Batch Number/ Expiry: 10 Batches
Problem:
Nupharm Laboratories is recalling the above batches due to the reported crystallisation of the product over time.
Company Contact:
Anne O’Grady, Head of Quality
Tel: 01244 287940
Mobile: 07713 939118
MHRA Medical Device Alert : Neonatal and paediatric support devices: Gel-E Donut and Squishon 2 manufactured by Philips Healthcare (Children’s Medical Ventures)
Neonatal and paediatric support devices
Gel-E Donut, part numbers:
92025-A, 92025-B, 92025-C
Squishon 2, part number:
91033-2
All batches
Manufactured by Philips Healthcare (Children’s Medical Ventures)
These are gel-filled products used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body.
For detailed information on recall alert CLICK HERE
Gel-E Donut, part numbers:
92025-A, 92025-B, 92025-C
Squishon 2, part number:
91033-2
All batches
Manufactured by Philips Healthcare (Children’s Medical Ventures)
These are gel-filled products used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body.
For detailed information on recall alert CLICK HERE
MHRA announces new guidance on reporting suspected adverse drug reactions in children and neonates
MHRA has announced new simplified guidance for healthcare professionals reporting suspected adverse drug reactions (ADRs) in children to its Yellow Card Scheme.
Changes to the guidelines follow a recent workshop with paediatric specialists, healthcare professionals and patient organisations who concluded that reporting all suspected ADRs in children was considered impractical for busy healthcare professionals and potentially acted as a barrier to reporting.
The new guidance is simpler and aligned with the reporting guidelines for adults. It asks that healthcare professionals report all suspected ADRs that are serious, medically significant or result in harm, and all those that are associated with newer drugs and vaccines identified by the black triangle symbol.
This guidance applies to medicines, vaccines, herbal or complementary products, whether self-medicated or prescribed, and includes suspected ADRs associated with misuse and unlicensed medicines.
It also places greater importance on the reporting of medication errors in children resulting in suspected ADRs, and provides information on why reporting these reactions in children and neonates is particularly important.
Director of Vigilance and Risk Management of Medicines, Dr June Raine said:
“We strongly encourage healthcare professionals to help improve adverse drug reaction data by reporting suspected adverse drug reactions in children and neonates using the new simplified guidance.
“The effects of medicines in children can be different to adults and in order to widen our knowledge on any possible side effects in this young age group for existing and new drugs, it is vital that we receive reports.
“The quickest way to send a Yellow Card is online at mhra.gov.uk/yellowcard. Healthcare professional should inform patients about the Scheme and encourage them to also report themselves.”
Dr Hilary Cass, President of the Royal College of Paediatrics and Child Health, said:
“Reporting adverse reactions quickly and accurately is key to ensuring medicines are safe and effective for children and young people. These new guidelines should help speed up the process and mean that healthcare professionals are not put off by complex forms and unclear processes The key message is – if you suspect a serious adverse drug reaction in a child – it must be reported and the best way of doing so it via the online Yellow Card.”
For details on Guidance Document CLICK HERE
MHRA published Consultation on the proposals for amendments to the Human Medicines Regulations 2012...
MHRA has announced a consultation (MLX388) is asking for the comments on proposals to amend the Human Medicines Regulations 2012 so that Public Health England (PHE) can develop and authorize Patient Group Directions (PGDs).
The changes to the Human Medicines Regulations 2012 will strengthen the response to outbreaks of infectious disease and other incidents by extending the use of PGDs to staff employed by Public Health England.
Documents to download for Consultations are:
MHRA Medical Device Recall Alert : Portex® endotracheal tube holder (2.5mm and 3.0mm) manufactured by Smiths Medical
Portex® endotracheal tube holder (2.5mm and 3.0mm) sold as stand-alone products or packaged in intubation kits.
Manufactured by Smiths Medical.
Specific product codes and lot numbers.
PROBLEM:
Manufactured by Smiths Medical.
Specific product codes and lot numbers.
PROBLEM:
Risk of extubation or delay to therapy as there may be
difficulty passing a suction catheter through the endotracheal tube when
the holder is locked. There may also be difficulty locking the holder.
This is due to a manufacturing problem, which means the holder might compress the endotracheal tube.
Smiths Medical has issued a Field Safety Notice (FSN) recalling affected devices but hasn’t had sufficient confirmation that customers have received it and acted on it.
For detailed information on recall alert CLICK HERE
This is due to a manufacturing problem, which means the holder might compress the endotracheal tube.
Smiths Medical has issued a Field Safety Notice (FSN) recalling affected devices but hasn’t had sufficient confirmation that customers have received it and acted on it.
For detailed information on recall alert CLICK HERE
MHRA : Annual Report and Accounts 2013/14
The Medicines and Healthcare Products Regulatory Agency Annual Report
and Accounts 2013/14 were laid in Parliament on 21 July 2014.
The Annual Report and Accounts give a selective overview of the events that have had most impact on the agency during the past year. This included the successful merger of the functions of the medicines and medical devices regulatory functions (MHRA) and Clinical Practice Research Datalink (CPRD) with the National Institute for Biological Standards and Control (NIBSC).
To Download MHRA Annual Report and Accounts of 2013/14. Please CLICK HERE
The Annual Report and Accounts give a selective overview of the events that have had most impact on the agency during the past year. This included the successful merger of the functions of the medicines and medical devices regulatory functions (MHRA) and Clinical Practice Research Datalink (CPRD) with the National Institute for Biological Standards and Control (NIBSC).
To Download MHRA Annual Report and Accounts of 2013/14. Please CLICK HERE
MHRA Medical Device Recall Alert: Ellipse™ VR/DR implantable cardioverter defibrillators manufactured by St Jude Medical...
CAS deadlines
Action underway: 23 September 2014, action complete: 17 November 2014
EllipseTM VR/DR implantable cardioverter defibrillators (ICDs).
Model numbers CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C and -36QC suffixes). All serial numbers distributed before the field action.
Manufactured by St Jude Medical.
PROBLEM:
Potential for delayed or insufficient energy defibrillation therapy due to a capacitor fault.
St Jude Medical issued a FSN dated 19 August 2014, describing a potential failure mode which can delay or reduce the therapy that can be delivered by the ICD. The problem has been traced to an ICD capacitor defect, accompanied in some returned devices with evidence of arcing between the capacitor anode and cathode. Analysis so far indicates that it is not possible to predict which ICDs will suffer this failure or when it may occur, so despite a low failure rate of 0.42%, all patients and clinicians will need to be vigilant.
All affected ICDs will exhibit extended charge times, evident not only during device testing / maintenance but also when preparing to deliver therapy. To date all potential failures reported to St Jude Medical have been identified through timeout warnings triggered by automated capacitor maintenance or during in-clinic testing, rather than being associated with serious adverse events.
The manufacturer has confirmed that all affected ICDs should now have been retrieved from hospital supplies and they are currently replacing them with newly designed product not expected to be susceptible to this failure mode. Replacement product can be identified according to the serial numbers detailed at the end of the FSN, and by the green label fixed to the ICD packaging.
For Detailed Information on Recall CLICK HERE
Action underway: 23 September 2014, action complete: 17 November 2014
EllipseTM VR/DR implantable cardioverter defibrillators (ICDs).
Model numbers CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C and -36QC suffixes). All serial numbers distributed before the field action.
Manufactured by St Jude Medical.
PROBLEM:
Potential for delayed or insufficient energy defibrillation therapy due to a capacitor fault.
St Jude Medical issued a FSN dated 19 August 2014, describing a potential failure mode which can delay or reduce the therapy that can be delivered by the ICD. The problem has been traced to an ICD capacitor defect, accompanied in some returned devices with evidence of arcing between the capacitor anode and cathode. Analysis so far indicates that it is not possible to predict which ICDs will suffer this failure or when it may occur, so despite a low failure rate of 0.42%, all patients and clinicians will need to be vigilant.
All affected ICDs will exhibit extended charge times, evident not only during device testing / maintenance but also when preparing to deliver therapy. To date all potential failures reported to St Jude Medical have been identified through timeout warnings triggered by automated capacitor maintenance or during in-clinic testing, rather than being associated with serious adverse events.
The manufacturer has confirmed that all affected ICDs should now have been retrieved from hospital supplies and they are currently replacing them with newly designed product not expected to be susceptible to this failure mode. Replacement product can be identified according to the serial numbers detailed at the end of the FSN, and by the green label fixed to the ICD packaging.
For Detailed Information on Recall CLICK HERE
MHRA CLDA Company-Led Drug Alert - Dopacard 50mg/5ml Concentrate for Solution in 5ml vials - Cephalon UK Limited - CLDA (14)A/16
Company-led recalls
15 September 2014
CLDA number: CLDA (14)A/16MDR number: 22-09/14
Company name: Cephalon UK Limited
Product description: Dopacard 50mg/5ml Concentrate for Solution in 5ml vials, PL 16260/0023 (Dopexamine hydrochloride)
Batch number/expiry: 225738E01, 31/10/2015
Brief description of problem:
Teva UK limited, on behalf of Cephalon UK Limited, is recalling the above batch because two vials within the batch were found to have a grey discolouration and did not, therefore, comply with the required specification.
Company contact for stock enquiries:
Teva UK Customer Service team
0800 590 502
Company contact for medical information enquiries:
Teva UK Limited
0207 5407 117
Email: medinfo@tevauk.com
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