TALQUISTINA
Informació principal
- Denominació comercial:
- TALQUISTINA polvo 50 g
- ingredients actius:
- difenhidramina asociada
- Codi ATC:
- F0230
- Designació comuna internacional (DCI):
- difenhidramina associated
- formulario farmacéutico:
- Polvos tópicos
- Vía de administración:
- Tópica
- Utilitza per:
- Humans
- Tipo de medicina:
- medicament al·lopàtic
Documents
- per al públic en general:
- Prospecte
-
- per als professionals de la salut:
- El prospecte d'informació d'aquest producte no està disponible actualment, pot enviar una petició al nostre servei al client i li notificarem tan aviat com ens sigui possible per aconseguir-ho.
Sol·licitar el prospecte d'informació per als professionals sanitaris.
Localització
- Disponible en:
-
Andorra
- Idioma:
- català
Altres dades
Estat
- Font:
- CedimCat - Centre d'Informació de Medicaments de Catalunya
- Número d'autorització:
- 152729
- última actualització:
- 25-05-2018
Prospecte: composició, indicacions, interacció, posologia, embaràs, lactància, reaccions adverses
TALQUISTINA polvo 50 g
difenhidramina asociada
Indicacions
Medicament que alleuja la picor i coïssor de la pell produïdes per al·lèrgies, cremades, picades d'insectes,
malalties de la pell, etc. (ANTIPRURIGINÓS).
Consideracions
Renti's les mans abans i després de cada aplicació.
Netegi i assequi bé la zona a tractar abans de cada aplicació.
Empolvori les pólvores sobre la zona afectada i distribueixi-les homogèniament amb el palpís dels dits.
Eviti aplicar aquest medicament sobre qualsevol ferida.
Vagi amb compte si ha de fer-lo servir a zones properes als ulls o mucoses (nas, llavis, genitals, etc.).
NO utilitzi embenats, gases, tiretes o apòsits sobre el medicament, tret que el seu metge li indiqui el
contrari.
NO s'apliqui altres productes per a la pell a la zona afectada, tret que el seu metge li indiqui el contrari.
Segueixi estrictament la pauta indicada pel seu metge pel que fa a dosi i freqüència d'administració.
Efectes adversos
Si vostè segueix la pauta indicada, no solen aparèixer efectes adversos.
Posologia
Aplicar cada 8 hores sobre la zona afectada.
VIA TÒPICA.
- L'accés a aquest document només està disponible per a usuaris registrats.
Fes-ara per tenir accés complet
20-2-2019

Salmonella control in poultry flocks and its public health impact
Published on: Mon, 18 Feb 2019 An increase in confirmed human salmonellosis cases in the EU after 2014 triggered investigation of contributory factors and control options in poultry production. Reconsideration of the five current target serovars for breeding hens showed that there is justification for retaining Salmonella Enteritidis, Salmonella Typhimurium (including monophasic variants) and Salmonella Infantis, while Salmonella Virchow and Salmonella Hadar could be replaced by Salmonella Kentucky and ...
Europe - EFSA - European Food Safety Authority EFSA Journal
12-2-2019

Health Canada will be updating its safety review of breast implants
OTTAWA - Health Canada will be updating its safety review of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) following an increase in reports of Canadian cases. As of January 1, 2019, Health Canada has received reports of 22 confirmed and 22 suspected Canadian cases of BIA-ALCL. In its initial safety review in 2017, Health Canada found that the rate of BIA-ALCL cases was low, with 5 confirmed Canadian cases of BIA-ALCL reported by Canadian manufacturers in the last 10 years. Increased...
Health Canada
1-2-2019

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM
Published on: Thu, 31 Jan 2019 The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. gluta...
Europe - EFSA - European Food Safety Authority EFSA Journal
26-1-2019

Overview of available toxicity data for calystegines
Published on: Fri, 25 Jan 2019 Calystegines are polyhydroxylated nortropane alkaloids that have been found in various solanaceous foods, in particular in potatoes and aubergines. The biological activity and potential toxicity of calystegines are associated with their capacity to inhibit glycosidases and block carbohydrate metabolism inducing lysosomal storage toxicity. The present report summarises the retrieved information on the possible toxicity of calystegines. Only few in vivo short‐term toxicologi...
Europe - EFSA - European Food Safety Authority EFSA Journal
8-1-2019

Antimicrobial resistance
Antimicrobial resistance is a major international human and animal health issue, because the emergence and spread of drug-resistant strains of bacteria call into question the efficacy of these treatments in humans and animals alike. Preserving the effectiveness of antibiotics is therefore a genuine public health challenge requiring an integrated approach across all types of medicine, according to the "One Health" concept covering both humans and animals. ANSES has mobilised significant resources to addr...
France - Agence Nationale du Médicament Vétérinaire
14-12-2018

Preparation and handling of slime: the health authorities call for continued vigilance
ANSES, the DGS and the DGCCRF are reiterating the risks associated with preparing and handling "slime", a sticky and elastic putty for kneading that is very popular with children and adolescents. The repeated and prolonged handling of this putty can cause skin irritations and allergies that are sometimes severe. From January to May 2018, the number of reported cases was double the number for all of 2017.
France - Agence Nationale du Médicament Vétérinaire
12-12-2018

Del Monte Foods Announces Limited Recall of Canned Fiesta Corn Seasoned with Red & Green Peppers Due to Under Processing
Del Monte Foods Inc. announced a recall of 64,242 cases of FIESTA CORN Seasoned with Red & Green Peppers due to under-processing. These deviations were part of the commercial sterilization process and could result in contamination by spoilage organisms or pathogens, which could lead to life-threatening illness if consumed. It is important to note that there have been no reports of illness associated with these products to date. No other production codes or products are affected by this recall.
FDA - U.S. Food and Drug Administration
5-12-2018

Public health risks associated with food‐borne parasites
Published on: Tue, 04 Dec 2018 Parasites are important food‐borne pathogens. Their complex lifecycles, varied transmission routes, and prolonged periods between infection and symptoms mean that the public health burden and relative importance of different transmission routes are often difficult to assess. Furthermore, there are challenges in detection and diagnostics, and variations in reporting. A Europe‐focused ranking exercise, using multicriteria decision analysis, identified potentially food‐borne ...
Europe - EFSA - European Food Safety Authority Publications
1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031
Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...
Europe - EFSA - European Food Safety Authority Publications
31-10-2018

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
FDA - U.S. Food and Drug Administration
30-10-2018

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide
There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.
Danish Medicines Agency
26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products
Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...
Europe - EFSA - European Food Safety Authority Publications
18-10-2018

Infections associated with heater-cooler devices
TGA web statment on the post-market review of heater-coolers has been updated
Therapeutic Goods Administration - Australia
10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer
The health risks associated with exposure to artificial UV radiation from tanning booths have been well established for many years now. ANSES points out that recent data on the subject support previous assessments: there is a proven cancer risk associated with UV radiation from artificial tanning equipment. The Agency therefore recommends that the public authorities take the necessary steps to prevent people from being exposed to artificial UV radiation from tanning booths used for cosmetic purposes.
France - Agence Nationale du Médicament Vétérinaire
20-9-2018

Animal Drug Safety Communication: FDA Alerts Pet Owners and Veterinarians About Potential for Neurologic Adverse Events Associated with Certain Flea and Tick Products
FDA - U.S. Food and Drug Administration
18-9-2018

Synthetic pitches: the expert assessments currently available conclude that the risks to health are negligible
In recent years, the increasing use of tyre granulates for sports pitches and playgrounds has raised concerns about their potential impact on health and the environment. ANSES has analysed the studies and expert assessments currently available on this topic and reports the main findings regarding the potential risks associated with the use or installation of synthetic pitches. The existing studies conclude that the health risks are of little concern, but point to potential risks to the environment.
France - Agence Nationale du Médicament Vétérinaire
13-9-2018

Use of next‐generation sequencing in microbial risk assessment
Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...
Europe - EFSA - European Food Safety Authority Publications
11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre
Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...
Europe - EFSA - European Food Safety Authority Publications
11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants
Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...
Europe - EFSA - European Food Safety Authority Publications
29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident
Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...
Europe - EFSA - European Food Safety Authority Publications
22-8-2018

Orphan designation: Recombinant adeno-associated viral vector serotype 9 containing human iduronidase gene, for the: Treatment of mucopolysaccharidosis type I
Europe - EMA - European Medicines Agency
14-8-2018

Scientific guideline: Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted
The purpose of this procedure is to enable a consistent and proportionate process in reviewing and revising all European Union herbal monographs and European Union list entries adopted by the HMPC. The aim of this document is to describe how to identify the criteria/reasons that trigger the revision of European Union herbal monographs and list entries and the associated procedure and timelines for both the review and the revision.
Europe - EFSA - European Food Safety Authority EFSA Journal
21-2-2019

Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn
Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn
Europe - EMA - European Medicines Agency
21-2-2019

Orphan designation: Adeno-associated viral vector containing DNA encoding an RNAi targeting rhodopsin,adeno-associated viral vector containing a rhodopsin gene, Treatment of rhodopsin-linked retinitis pigmentosa, 17/12/2010, Withdrawn
Orphan designation: Adeno-associated viral vector containing DNA encoding an RNAi targeting rhodopsin,adeno-associated viral vector containing a rhodopsin gene, Treatment of rhodopsin-linked retinitis pigmentosa, 17/12/2010, Withdrawn
Europe - EMA - European Medicines Agency
14-2-2019

EU/3/18/1975 (Nightstar Europa Limited)
EU/3/18/1975 (Active substance: Adenovirus-associated viral vector serotype 8 containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)1376 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003405
Europe -DG Health and Food Safety
14-2-2019

EU/3/17/1969 (Maria Livadiotis)
EU/3/17/1969 (Active substance: Recombinant adeno-associated viral vector serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits) - Transfer of orphan designation - Commission Decision (2019)1357 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003568
Europe -DG Health and Food Safety
14-2-2019

EU/3/14/1290 (Nightstar Europa Limited)
EU/3/14/1290 (Active substance: Adeno-associated viral vector serotype 2 containing the human REP1 gene) - Transfer of orphan designation - Commission Decision (2019)1361 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003290
Europe -DG Health and Food Safety
13-2-2019

Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive
Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive
Europe - EMA - European Medicines Agency
1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names
Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474
Europe -DG Health and Food Safety
21-1-2019

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names
Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names (Active substance: Diclofenac sodium) - Community Referrals - Art 29 - Commission Decision (2019)589 of Mon, 21 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1467
Europe -DG Health and Food Safety
14-1-2019

Paclitaxel Hetero and associated names
Paclitaxel Hetero and associated names (Active substance: paclitaxel) - Community Referrals - Art 29 - Commission Decision (2019)205 of Mon, 14 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H//A-29(4)/1466
Europe -DG Health and Food Safety
11-1-2019

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of retinitis pigmentosa, 28/07/2015, Positive
Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of retinitis pigmentosa, 28/07/2015, Positive
Europe - EMA - European Medicines Agency
11-1-2019

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive
Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive
Europe - EMA - European Medicines Agency
11-1-2019

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive
Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive
Europe - EMA - European Medicines Agency
10-1-2019

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia
Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive
Europe - EMA - European Medicines Agency
7-1-2019

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1
Europe - EMA - European Medicines Agency
21-12-2018

Breast implant associated cancer (or BIA-ALCL)
Breast implant associated cancer, or breast implant associated anaplastic large cell lymphoma (BIA-ALCL), is a rare cancer of the immune system
Therapeutic Goods Administration - Australia
19-12-2018

Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene, Treatment of spinal muscular atrophy, 24/08/2018, Positive
Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene, Treatment of spinal muscular atrophy, 24/08/2018, Positive
Europe - EMA - European Medicines Agency
19-12-2018

Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive
Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive
Europe - EMA - European Medicines Agency
19-12-2018

Perlinring and associated names
Perlinring and associated names (Active substance: etonogestrel/ethinylestradiol) - Community Referrals - Art 29 - Commission Decision (2018)9141 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1473
Europe -DG Health and Food Safety
18-12-2018

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20
Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised
Europe - EMA - European Medicines Agency
18-12-2018

EU/3/18/2109 (Yes Pharmaceutical Development Services GmbH)
EU/3/18/2109 (Active substance: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase) - Orphan designation - Commission Decision (2018)9024 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/153/18
Europe -DG Health and Food Safety
18-12-2018

EU/3/18/2108 (Pharma Gateway AB)
EU/3/18/2108 (Active substance: Adeno-associated viral vector expressing human 21-hydroxylase) - Orphan designation - Commission Decision (2018)9023 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/18
Europe -DG Health and Food Safety
18-12-2018

Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive
Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive
Europe - EMA - European Medicines Agency
18-12-2018

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance
TGA is seeking comments on the expansion and amendment of TGO 54. Closing date: 12 February 2019
Therapeutic Goods Administration - Australia
12-12-2018

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette
Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette
Europe - EMA - European Medicines Agency
12-12-2018

Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein
Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein
Europe - EMA - European Medicines Agency
12-12-2018

Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus (AAV) vector encoding genes from an algae channel rhodopsin
Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus (AAV) vector encoding genes from an algae channel rhodopsin
Europe - EMA - European Medicines Agency
10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)
EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509
Europe -DG Health and Food Safety
10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)
EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507
Europe -DG Health and Food Safety
10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)
EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508
Europe -DG Health and Food Safety
28-11-2018

Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018
Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018
Europe - EMA - European Medicines Agency
21-11-2018

EU/3/16/1716 (Pfizer Europe MA EEIG)
EU/3/16/1716 (Active substance: Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene) - Transfer of orphan designation - Commission Decision (2018)7837 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/16/T/02
Europe -DG Health and Food Safety
14-11-2018

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/x
The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn
FDA - U.S. Food and Drug Administration
2-11-2018

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt #MedicalDevice #FDA
#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt #MedicalDevice #FDA
FDA - U.S. Food and Drug Administration
30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)
EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18
Europe -DG Health and Food Safety
30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)
EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18
Europe -DG Health and Food Safety
19-10-2018

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW #FDA #MedicalDevice
New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW #FDA #MedicalDevice
FDA - U.S. Food and Drug Administration
2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)
EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02
Europe -DG Health and Food Safety
17-9-2018

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open
The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....
Europe - EMA - European Medicines Agency
7-9-2018

Consumer story: Georgia and breast implant associated cancer
Learn how to spot the warning signs for breast implant associated cancer in our new consumer story
Therapeutic Goods Administration - Australia
28-8-2018

EU/3/18/2060 (Biogen Idec Limited)
EU/3/18/2060 (Active substance: Adeno-associated viral vector serotype hu68 containing the human SMN1 gene) - Orphan designation - Commission Decision (2018)5732 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/18
Europe -DG Health and Food Safety
28-8-2018

EU/3/18/2067 (Omeros London Limited)
EU/3/18/2067 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)5737 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/044/18
Europe -DG Health and Food Safety
17-8-2018

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd #MedicalDevices
#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd #MedicalDevices
FDA - U.S. Food and Drug Administration