ANTI-BIT

Genel Bilgiler

  • Ticaret Unvanı:
  • ANTI-BIT 150 ML SAMPUAN
  • Reçete türü:
  • Normal
  • İçin kullanmak:
  • İnsanlar
  • İlaç türü:
  • allopatik ilaç

Belgeler

Yerelleştirme

  • Bulunduğu ülkeler::
  • ANTI-BIT 150 ML SAMPUAN
    Türkiye
  • Dil:
  • Türkçe

Terapötik bilgiler

  • Terapötik alanı:
  • phenothrin

Diğer bilgiler

Durum

  • Kaynak:
  • TİTCK - TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU - Türkiye
  • Yetkilendirme durumu:
  • Aktif
  • Yetkilendirme numarası:
  • 8699502560208
  • Yetkilendirme tarihi:
  • 29-01-2013
  • Son Güncelleme:
  • 25-05-2018

Hasta Bilgi broşürü: Ürün Özellikleri Özeti - kompozisyon, endikasyonlar, yan etkiler, dozaj, etkileşimleri, advers reaksiyonlar, gebelik, laktasyon

13-12-2018

Pest categorisation of Septoria malagutii

Pest categorisation of Septoria malagutii

Published on: Wed, 12 Dec 2018 The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into t...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Following the five-year re-approval of this active substance at European level in December 2017, ANSES is reassessing marketing authorisations for products containing glyphosate. For products for which an application for authorisation or re-authorisation has been submitted, the Agency will carry out a comparative assessment with the available alternatives. For each glyphosate-based product, all uses for which there is an alternative that meets the substitution criteria will therefore be prohibited.

France - Agence Nationale du Médicament Vétérinaire

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

Health Canada

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

7-9-2018

Jacent recalls Crave Party Candles

Jacent recalls Crave Party Candles

Candles which can spontaneously re-ignite are prohibited in Canada by the Candles Regulations under the Canada Consumer Product Safety Act as they can re-ignite after disposal, potentially causing fires.

Health Canada

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

3-8-2018

Apricot kernels pose a risk of cyanide poisoning

Apricot kernels pose a risk of cyanide poisoning

A familiar ingredient for jam-makers, apricot kernels are increasingly being consumed as a natural remedy for their claimed "anti-cancer" properties. While one kernel added to perfume several jars of jam is not a problem, ingesting them in large quantities exposes consumers to the risk of cyanide poisoning. ANSES has identified several cases of apricot kernel poisoning in France through its toxicovigilance scheme, and encourages consumers to exercise caution.

France - Agence Nationale du Médicament Vétérinaire

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

18-7-2018

"Anti-pollution" masks: not enough data to demonstrate a health benefit and justify recommending their use

"Anti-pollution" masks: not enough data to demonstrate a health benefit and justify recommending their use

In a context where prevention of ambient air pollution is a real public health issue, questions are regularly asked about the value of recommending that the population wear personal protective equipment. This led ANSES to assess the potential health benefits of wearing "anti-pollution" masks. Its expert appraisal revealed a lack of data demonstrating a health benefit. To reduce the health impacts associated with ambient air pollution, the Agency reiterates the importance of prioritising action at the sou...

France - Agence Nationale du Médicament Vétérinaire

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

21-5-2018

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Liubitelskie Cookies”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/18/2094 (Y-mAbs Therapeutics A/S)

EU/3/18/2094 (Y-mAbs Therapeutics A/S)

EU/3/18/2094 (Active substance: Anti-GD2 monoclonal antibody 3F8 humanised) - Orphan designation - Commission Decision (2018)7804 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/126/18

Europe -DG Health and Food Safety

1-11-2018

Comparable Overseas Reports (COR-A) pathway - First registration decision

Comparable Overseas Reports (COR-A) pathway - First registration decision

Cabozantinib (CABOMETYX) is the first medicine to be registered via the new COR-A pathway

Therapeutic Goods Administration - Australia

26-9-2018

Today, the National Breast Implant Registry opened. This new registry, a collaboration between @ASPSMembers, implant manufacturers and #FDA, provides an important new platform for evaluating real world data on the safety and performance of breast implants

Today, the National Breast Implant Registry opened. This new registry, a collaboration between @ASPSMembers, implant manufacturers and #FDA, provides an important new platform for evaluating real world data on the safety and performance of breast implants

Today, the National Breast Implant Registry opened. This new registry, a collaboration between @ASPSMembers, implant manufacturers and #FDA, provides an important new platform for evaluating real world data on the safety and performance of breast implants https://bit.ly/2OU7wKX 

FDA - U.S. Food and Drug Administration

24-9-2018

aimed at determining how best to assess safety and effectiveness of digital health technologies without inhibiting patient access. Click on the link to register:  https://bit.ly/2pxdczF 

aimed at determining how best to assess safety and effectiveness of digital health technologies without inhibiting patient access. Click on the link to register: https://bit.ly/2pxdczF 

aimed at determining how best to assess safety and effectiveness of digital health technologies without inhibiting patient access. Click on the link to register: https://bit.ly/2pxdczF 

FDA - U.S. Food and Drug Administration

21-9-2018

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like  activity trackers, social media, and patient registries to better  understand their needs.  Click the link for more information about the upcoming meeting:  https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https://bit.ly/2MUNqhU 

FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

29-8-2018

Cinryze (Shire Services BVBA)

Cinryze (Shire Services BVBA)

Cinryze (Active substance: C1 inhibitor, human) - Centralised - Yearly update - Commission Decision (2018)5767 of Wed, 29 Aug 2018

Europe -DG Health and Food Safety

29-8-2018

Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

23-8-2018

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Corrigendum - Commission Decision (2018)1246 of Thu, 23 Aug 2018

Europe -DG Health and Food Safety

22-8-2018

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye:  http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz .pic.twitter.com/ecJErFeiSH

After over 20 years of wearing contact lenses, this freelance blogger had an unexpected diagnosis in her left eye: http://bit.ly/2h2NcHz . pic.twitter.com/ecJErFeiSH

FDA - U.S. Food and Drug Administration

21-8-2018

Do you wear contact lenses? This rare but serious infection of the eye primarily affects people who wear contact lenses. #GuessthePathogen, and make sure to practice healthy habits  http://bit.ly/2ifnt2O  #ContactLensHealthWeekpic.twitter.com/ZBZAAtbrVr

Do you wear contact lenses? This rare but serious infection of the eye primarily affects people who wear contact lenses. #GuessthePathogen, and make sure to practice healthy habits http://bit.ly/2ifnt2O  #ContactLensHealthWeekpic.twitter.com/ZBZAAtbrVr

Do you wear contact lenses? This rare but serious infection of the eye primarily affects people who wear contact lenses. #GuessthePathogen, and make sure to practice healthy habits http://bit.ly/2ifnt2O  #ContactLensHealthWeek pic.twitter.com/ZBZAAtbrVr

FDA - U.S. Food and Drug Administration

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Active substance: 2'-O-(2-methoxyethyl) antisense oligonucleotide targeting microtubule-associated protein tau pre-mRNA) - Orphan designation - Commission Decision (2018)5273 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/18

Europe -DG Health and Food Safety

22-7-2018

But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market  https://bit.ly/2vnc1Zl   may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial

But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market https://bit.ly/2vnc1Zl  may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial

But predicates may be decades old. Our new “expanded abbreviated” 510(k) path to market https://bit.ly/2vnc1Zl  may drive greater market competition for safer devices. It explains how objective performance criteria may be used to demonstrate substantial equivalence.

FDA - U.S. Food and Drug Administration

22-7-2018

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path  https://bit.ly/2O43EqH  and providing streamlined paths for

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path https://bit.ly/2O43EqH  and providing streamlined paths for

We’re exploring ways to use umbrella regulation or seek authority to address new risks faster. We're pursuing ways to spur innovation in safer devices; creating a Breakthrough Devices-like path https://bit.ly/2O43EqH  and providing streamlined paths for comparative safety claims pic.twitter.com/30wLydOAec

FDA - U.S. Food and Drug Administration

22-7-2018

We must address data gaps on tech for women’s health. Our new Women’s Health Technologies Strategically Coordinated Registry Network  https://bit.ly/2L4Tqsx  provides more evidence on areas as uterine fibroids, pelvic floor disorders & female long-acting

We must address data gaps on tech for women’s health. Our new Women’s Health Technologies Strategically Coordinated Registry Network https://bit.ly/2L4Tqsx  provides more evidence on areas as uterine fibroids, pelvic floor disorders & female long-acting

We must address data gaps on tech for women’s health. Our new Women’s Health Technologies Strategically Coordinated Registry Network https://bit.ly/2L4Tqsx  provides more evidence on areas as uterine fibroids, pelvic floor disorders & female long-acting reversible contraception pic.twitter.com/TAWmVh99oL

FDA - U.S. Food and Drug Administration

22-7-2018

I, along with my CDRH colleagues, recently unveiled #FDA’s Medical Device Safety Action Plan  https://bit.ly/2Hpc3l9  that builds on these substantial efforts, and reflects the dedication & expertise of #FDA professional staff to these issuespic.twitter.c

I, along with my CDRH colleagues, recently unveiled #FDA’s Medical Device Safety Action Plan https://bit.ly/2Hpc3l9  that builds on these substantial efforts, and reflects the dedication & expertise of #FDA professional staff to these issuespic.twitter.c

I, along with my CDRH colleagues, recently unveiled #FDA’s Medical Device Safety Action Plan https://bit.ly/2Hpc3l9  that builds on these substantial efforts, and reflects the dedication & expertise of #FDA professional staff to these issues pic.twitter.com/8NkA9VzKM4

FDA - U.S. Food and Drug Administration

22-7-2018

Once on market, #FDA monitors for safety issues by collecting adverse event reports  https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t prov

Once on market, #FDA monitors for safety issues by collecting adverse event reports https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t prov

Once on market, #FDA monitors for safety issues by collecting adverse event reports https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t provide real-time information pic.twitter.com/WJMYVcAyoQ

FDA - U.S. Food and Drug Administration

16-7-2018

If you are misusing an #opioid just to keep from getting sick from #withdrawal symptoms, it’s time to break the cycle of dependence. Read our “Finding Quality Treatment for Substance Use Disorders” for hotline and provider information.  http://bit.ly/2EIJ

If you are misusing an #opioid just to keep from getting sick from #withdrawal symptoms, it’s time to break the cycle of dependence. Read our “Finding Quality Treatment for Substance Use Disorders” for hotline and provider information. http://bit.ly/2EIJ

If you are misusing an #opioid just to keep from getting sick from #withdrawal symptoms, it’s time to break the cycle of dependence. Read our “Finding Quality Treatment for Substance Use Disorders” for hotline and provider information. http://bit.ly/2EIJb9l  #MondayMotivation

FDA - U.S. Food and Drug Administration

29-6-2018

Smoking among adolescents has declined but #ecigarette use is growing in popularity. See trends on teen #tobacco use and regulation efforts  http://bit.ly/1EE2lpG  via @TeenHealthGov

Smoking among adolescents has declined but #ecigarette use is growing in popularity. See trends on teen #tobacco use and regulation efforts http://bit.ly/1EE2lpG  via @TeenHealthGov

Smoking among adolescents has declined but #ecigarette use is growing in popularity. See trends on teen #tobacco use and regulation efforts http://bit.ly/1EE2lpG  via @TeenHealthGov

FDA - U.S. Food and Drug Administration

29-6-2018

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit  https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFridaypic.twitter.com/JWK672XtdI

A past diagnosis of asthma is also associated with #COPD in 20% of the cases. Visit https://bit.ly/1xErH2t  to learn more. #FactFriday pic.twitter.com/JWK672XtdI

FDA - U.S. Food and Drug Administration

29-6-2018

As many parts of the U.S. face an excessive heat warning, know how to spot heat stroke–and know when it's time to get medical help.  http://bit.ly/2tO5WkM pic.twitter.com/wF6D2CbUEe

As many parts of the U.S. face an excessive heat warning, know how to spot heat stroke–and know when it's time to get medical help. http://bit.ly/2tO5WkM pic.twitter.com/wF6D2CbUEe

As many parts of the U.S. face an excessive heat warning, know how to spot heat stroke–and know when it's time to get medical help. http://bit.ly/2tO5WkM  pic.twitter.com/wF6D2CbUEe

FDA - U.S. Food and Drug Administration

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (Active substance: ombitasvir / paritaprevir / ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3766 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3839/T/45

Europe -DG Health and Food Safety

24-5-2018

Want a #HealthyHeart? Get moving! Here are some ways you can #MoveWithHeart today!  http://bit.ly/2II1XR2  #MoveInMay #HypertensionMonthpic.twitter.com/3teHPIlA40

Want a #HealthyHeart? Get moving! Here are some ways you can #MoveWithHeart today! http://bit.ly/2II1XR2  #MoveInMay #HypertensionMonthpic.twitter.com/3teHPIlA40

Want a #HealthyHeart? Get moving! Here are some ways you can #MoveWithHeart today! http://bit.ly/2II1XR2  #MoveInMay #HypertensionMonth pic.twitter.com/3teHPIlA40

FDA - U.S. Food and Drug Administration

18-5-2018

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Genzyme Europe B.V.)

EU/3/14/1298 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3148 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/041/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Genzyme Europe B.V.)

EU/3/14/1297 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2018)3147 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/039/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (Active substance: Humanised recombinant IgG4 anti-human tau antibody) - Transfer of orphan designation - Commission Decision (2018)3024 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/239/15/T/01

Europe -DG Health and Food Safety

15-5-2018

CABOMETYX (Ipsen Pharma)

CABOMETYX (Ipsen Pharma)

CABOMETYX (Active substance: cabozantinib) - Centralised - 2-Monthly update - Commission Decision (2018)3015 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4163/II/3

Europe -DG Health and Food Safety