EPRO 155 RINSE ADD

Informasi Utama

  • Nama dagang:
  • EPRO 155 RINSE ADD
  • Digunakan untuk:
  • manusia
  • Jenis Obat:
  • Perangkat medis

Dokumen

  • untuk masyarakat umum:
  • Informasi leaflet untuk produk ini saat ini tidak tersedia, Anda dapat mengirim permintaan untuk layanan pelanggan kami dan kami akan memberitahu Anda segera setelah kami mampu mendapatkannya.


    Meminta selebaran informasi untuk masyarakat umum.

Lokalisasi

  • Tersedia di:
  • EPRO 155 RINSE ADD
    Indonesia
  • Bahasa:
  • Bahasa Indonesia

Informasi lainnya

Status

  • Sumber:
  • Ecolab
  • Nomor Otorisasi:
  • 914598-13
  • Pembaharuan Terakhir:
  • 12-03-2018

Ringkasan karakteristik Produk: dosis, interaksi, efek samping

EPRO 155 RINSE ADD

Bilas bahan tambahan

LEMBAR DATA KEAMANAN

Nama produk

Penggunaan dan

pembatasan yang

direkomendasikan

Nomor telepon darurat

:

:

Informasi pemasok

:

EPRO 155 RINSE ADD

Gunakan hanya untuk tujuan pada label produk.

:

Bagian 1. Identifikasi produk kimia dan perusahaan

Nama-nama lain

:

Tidak ada.

Informasi pengenceran

produk

:

0.026 - 0.078%

PT. Ecolab Indonesia

Jl. Jababeka XII Kav V-37

Kawasan Industri jababeka, Cikarang

Indonesia 17350

Tel : (62-21) 5707557 Fax : (62-21) 5707682

+1 651-222-5352

IRITASI/ KERUSAKAN PARAH PADA MATA -

BAHAYA TOKSISITAS AKUT PADA

LINGKUNGAN AKUATIK - 3

Klasifikasi GHS

(Globally

Harmonised System

~ Sistim Harmonisasi

Global)

:

Kata sinyal

:

Peringatan

Pernyataan bahaya

:

Menyebabkan iritasi mata pada mata.

Berbahaya terhadap kehidupan akuatik.

Pernyataan kehati-hatian

Pencegahan

:

Hindari pelepasan ke lingkungan. Cuci tangan

dengan bersih setelah penanganan.

Tanggapan

:

JIKA TERKENA MATA: Bilas secara hati-hati

dengan air selama beberapa menit. Lepaskan

lensa kontak jika memakainya dan mudah

dilakukan. Lanjutkan membilas. Jika iritasi

mata berlanjut: Dapatkan nasihat medis.

Penyimpanan

:

Tidak teridentifikasi adanya tindakan khusus

lainnya.

Pembuangan

:

Buang isi dan wadah sesuai dengan peraturan

lokal, regional, nasional dan internasional.

Bahaya lain

:

Tidak diketahui.

2. Identifikasi Bahaya

Elemen label GHS

Produk TERJUAL

Penggunaan produk dicairkan

Tidak diklasifikasikan.

Tanpa Kata Sinyal

Tidak diketahui efek signifikan atau bahaya

kritis.

Cuci sepenuhnya sesudah penanganan.

Tidak berlaku.

Tidak teridentifikasi adanya tindakan khusus

lainnya.

Tidak berlaku.

Tidak diketahui.

914598-13

Halaman: 1/6

EPRO 155 RINSE ADD

Campuran

3. Komposisi/ Informasi tentang Bahan Penyusun Senyawa tunggal

Zat/sediaan

:

oksiran, metil-, polimer dengan oksiran

1 - 10

9003-11-6

ALKOHOL, C10-16, TERETOKSILASI

1 - 10

68002-97-1

Komponen-komponen yang berbahaya

Nomor CAS

Rentang konsentrasi (%)

Produk TERJUAL

Penggunaan produk dicairkan

Tidak terdapat bahan yang, sejauh pengetahuan pemasok saat ini dan pada konsentrasi yang berlaku,

diklasifikasikan sebagai berbahaya pada kesehatan atau lingkungan dan karenanya diperlukan pelaporan dalam

bagian ini.

Dapatkan pertolongan medis jika terjadi gejala.

Bilas secara hati-hati dengan air selama

beberapa menit. Lepaskan lensa kontak jika

memakainya dan mudah dilakukan. Lanjutkan

membilas. Dapatkan bantuan medis jika terjadi

iritasi.

Efek setelah terkena kulit tidak diketahui. Bilas

dengan air selama beberapa menit.

Tidak perlu tindakan khusus. Obati berdasarkan

gejala.

Kontak mata

Kontak kulit

Penghirupan

Tertelan

:

:

:

:

Perlindungan bagi

penolong pertama

:

Tidak boleh melakukan tindakan yang menyangkut risiko pribadi atau tanpa pelatihan yang

sesuai. Mungkin dapat membahayakan bagi orang yang memberikan pertolongan resusitasi dari

mulut-ke-mulut.

Catatan untuk

dokter

:

Obati berdasarkan gejala. Segera menghubungi ahli perawatan racun jika jumlah besar

termakan atau terhirup.

Lihat informasi toksikologi (bagian 11)

4. Tindakan Pertolongan Pertama

Produk TERJUAL

Penggunaan produk dicairkan

Efek setelah terkena mata tidak diketahui.

Bilas dengan air selama beberapa menit.

Efek setelah terkena kulit tidak diketahui.

Bilas dengan air selama beberapa menit.

Tidak perlu tindakan khusus. Obati

berdasarkan gejala.

Dapatkan pertolongan medis jika terjadi

gejala.

Jika ada kebakaran segera isolasi tempat kejadian dengan menjauhkan semua

orang dari lokasi kebakaran. Tidak boleh melakukan tindakan yang menyangkut

risiko pribadi atau tanpa pelatihan yang sesuai.

Produk dekomposisi termal

berbahaya

Bahaya spesifik yang

diakibatkan bahan kimia

tersebut

Bahan-bahan berikut ini mungkin dapat termasuk golongan produk penguraian-

hayati:

karbon dioksida

karbon monoksida

Dalam kebakaran atau jika dipanaskan, peningkatan tekanan akan terjadi dan

wadah bisa meledak. Bahan ini berbahaya bagi kehidupan air. Air bekas

memadamkan kebakaran yang tercemar dengan bahan ini harus dibendung dan

dicegah agar tidak mengalir masuk/dibuang ke saluran air, parit, atau selokan.

Petugas pemadam kebakaran harus memakai perlengkapan pelindung yang

memadai dan alat bantu pernapasan (Self-Contained Breathing Apparatus - SCBA)

yang berpelindung-wajah penuh dan yang beroperasi dalam mode tekanan positif.

Alat pelindung khusus

untuk petugas pemadam

kebakaran

Gunakan semprotan air, kabut atau busa.

:

:

:

Media yang sesuai untuk

pemadaman kebakaran

:

:

5. Tindakan Pemadaman Kebakaran

Produk TERJUAL

914598-13

Halaman: 2/6

EPRO 155 RINSE ADD

Langkah-langkah

pencegahan bagi

lingkungan

Tindakan

pencegahan pribadi

:

:

Gunakan alat pelindung diri sesuai kebutuhan.

Jaga agar tumpahan bahan dalam jumlah

banyak tidak mengalir ke tanah dan saluran air di

permukaan tanah.

Gunakan air bilas untuk pembersihan akhir.

Metode untuk

membersihan

:

6. Tindakan Penanggulangan jika terjadi Kebocoran

Produk TERJUAL

Penggunaan produk dicairkan

Gunakan alat pelindung diri sesuai

kebutuhan.

Jaga agar tumpahan bahan dalam jumlah

banyak tidak mengalir ke tanah dan saluran

air di permukaan tanah.

Gunakan air bilas untuk pembersihan akhir.

Menangani/

Penanganan

Penyimpanan

Cuci sepenuhnya sesudah penanganan.

Jauhkan dari jangkauan anak-anak. Pastikan

wadah tertutup rapat.

:

:

7. Penanganan dan Penyimpanan

Produk TERJUAL

Penggunaan produk dicairkan

Cuci sepenuhnya sesudah penanganan.

Jauhkan dari jangkauan anak-anak.

Simpan dalam suhu antara: 0 dan 50°C

Perlindungan

tangan

Tidak diperlukan respirator dalam kondisi normal

dan kondisi yang ditentukan untuk penggunaan

produk.

Tidak ada peralatan pelindung yang dibutuhkan

dalam kondisi pemakaian normal.

Tidak ada peralatan pelindung yang dibutuhkan

dalam kondisi pemakaian normal.

Perlindungam mata

Perlindungan

pernapasan

:

:

:

Perlindungan kulit

Tidak ada peralatan pelindung yang dibutuhkan

dalam kondisi pemakaian normal.

:

Pengendalian teknik

yang sesuai

:

Ventilasi umum yang baik semestinya cukup

untuk mengendalikan pemaparan pekerja

terhadap kadar kontaminasi yang terbawa-udara.

Cuci tangan, lengan dan wajah sampai bersih setelah menangani produk kimia, sebelum

makan, merokok dan menggunakan WC dan seusai waktu kerja. Teknik yang sesuai harus

digunakan untuk melepaskan/membuang pakaian berpotensi terkontaminasi. Cuci pakaian

yang terkontaminasi sebelum dipakai kembali.

Tindakan higienis

:

Parameter pengendalian

Perlindungan perorangan

8. Kontrol Paparan/Perlindungan Diri

Produk TERJUAL

Penggunaan produk dicairkan

Ventilasi umum yang baik semestinya cukup

untuk mengendalikan pemaparan pekerja

terhadap kadar kontaminasi yang terbawa-

udara.

Tidak ada peralatan pelindung yang

dibutuhkan dalam kondisi pemakaian normal.

Tidak ada peralatan pelindung yang

dibutuhkan dalam kondisi pemakaian normal.

Tidak diperlukan respirator dalam kondisi

normal dan kondisi yang ditentukan untuk

penggunaan produk.

Tidak ada.

Nama bahan

Batas pemaparan

Tidak ada peralatan pelindung yang

dibutuhkan dalam kondisi pemakaian normal.

914598-13

Halaman: 3/6

EPRO 155 RINSE ADD

Bentuk fisik

Titik lebur

Tekanan uap

Kerapatan relatif

Rapat uap

Kelarutan

Cairan.

Tidak tersedia.

1.01 (Air = 1)

Tidak tersedia.

Tidak tersedia.

Tidak tersedia.

Tidak berbau

Bau

pH

Hijau [Gelap]

Warna

Laju penguapan

(butil asetat = 1)

Tidak tersedia.

Suhu dapat

membakar sendiri

(auto-ignition)

Titik nyala

Tidak tersedia.

> 100°C

Produk tidak mendukung pembakaran

Tidak tersedia.

2.61 (100%)

Kekentalan

Tidak tersedia.

Koefisien partisi (n-

oktanol/air)

:

:

:

:

:

:

:

:

:

:

:

:

:

:

Titik didih

:

Tidak tersedia.

Flamabilitas

(padatan, gas)

:

Tidak tersedia.

Batas ledakan

:

Tidak tersedia.

9. Sifat Fisika dan Kimia

Produk TERJUAL

Penggunaan produk dicairkan

Cairan.

Bening.

Tidak berbau

7 sampai dengan 8

> 100°C

Suhu penguraian

Ambang bau

:

:

Tidak tersedia.

Tidak tersedia.

Hasil peruraian yang

berbahaya

Kondisi untuk dihindarkan

Jangan sampai kelepasan ke lingkungan.

Pada kondisi penyimpanan dan penggunaan yang normal, produk-produk

penguraian-hayati yang berbahaya seharusnya tidak terproduksi.

Produk ini stabil.

Stabilitas

Tidak tersedia.

:

:

:

Bahan untuk dihindari

:

Kemungkinan reaksi yang

berbahaya

:

Dibawah kondisi penyimpanan dan penggunaan yang normal, reaksi yang

berbahaya tidak akan terjadi.

10. Stabilitas dan Reaktifitas

Produk TERJUAL

Rute Paparan

:

Kontak kulit, Kontak mata, Penghirupan, Tertelan

11. Informasi Toksikologi

Gejala

Kontak kulit

Tertelan

Penghirupan

Tidak ada data khusus.

Tidak ada data khusus.

Tidak ada data khusus.

:

:

:

Kontak mata

:

Gejala-gejala gangguan kesehatan mungkin

akan meliputi:

iritasi

berair

kemerahan

Produk TERJUAL

Penggunaan produk dicairkan

Tidak ada data khusus.

Tidak ada data khusus.

Tidak ada data khusus.

Tidak ada data khusus.

914598-13

Halaman: 4/6

EPRO 155 RINSE ADD

11. Informasi Toksikologi

Data toksisitas

Nama produk/bahan

Hasil

Spesies

Dosis

Tidak diketahui efek signifikan atau bahaya kritis.

Karsinogenisitas

:

Tidak diketahui efek signifikan atau bahaya kritis.

Mutagenisitas

:

Tidak diketahui efek signifikan atau bahaya kritis.

Teratogenisitas

:

Efek-efek perkembangan

selama masa pertumbuhan

:

Tidak diketahui efek signifikan atau bahaya kritis.

Efek-efek kesuburan

:

Tidak diketahui efek signifikan atau bahaya kritis.

Toksisitas kronis

Toksisitas akut

Penghirupan

:

Tidak diketahui efek signifikan atau bahaya kritis.

Tidak diketahui efek signifikan atau bahaya kritis.

:

Tertelan

Kontak kulit

:

Tidak diketahui efek signifikan atau bahaya kritis.

Menyebabkan iritasi mata pada mata.

:

Kontak mata

Tidak diketahui efek signifikan atau bahaya

kritis.

Tidak diketahui efek signifikan atau bahaya

kritis.

Tidak diketahui efek signifikan atau bahaya

kritis.

Tidak diketahui efek signifikan atau bahaya

kritis.

oksiran, metil-, polimer dengan oksiran

LC50 Penghirupan

Debu dan kabut

Tikus besar

0.147 mg/l

LD50 Dermal

Kelinci

>2000 mg/kg

LD50 Oral

Tikus besar

>2000 mg/kg

ALKOHOL, C10-16, TERETOKSILASI

LC50 Penghirupan

Debu dan kabut

Tikus besar

>50 mg/l

LD50 Dermal

Tikus besar

>2000 mg/kg

LD50 Oral

Tikus besar

>1000 mg/kg

Mobilitas dalam tanah

Tidak tersedia.

:

Efek merugikan lainnya

:

Tidak diketahui efek signifikan atau bahaya kritis.

Efek keracunan pada organisme air dan darat

Nama produk/bahan

Spesies

Hasil

Pemaparan

Persistensi dan kemudahan terurai

Nama produk/bahan

Uji

Dosis

Hasil

Zat inokulasi

Ekotoksisitas

:

Bahan ini berbahaya bagi kehidupan air.

12. Informasi Ekologi

Produk TERJUAL

oksiran, metil-, polimer dengan oksiran

Akut LC50 >100 mg/l

Ikan

96 jam

ALKOHOL, C10-16, TERETOKSILASI

Akut EC50 >0.1 mg/l

Dafnia

48 jam

Tidak tersedia.

Produk diencerkan dapat disalurkan ke saluran

pembuangan sanitasi Buang kemasan kosong di

tempat sampah

:

Metode

pembuangan

13. Pertimbangan Pembuangan/Pemusnahan

Produk TERJUAL

Penggunaan produk dicairkan

Produk diencerkan dapat disalurkan ke

saluran pembuangan sanitasi Buang

kemasan kosong di tempat sampah

914598-13

Halaman: 5/6

EPRO 155 RINSE ADD

Nomor PBB Nama pengapalan yang sesuai

Penggolongan

Informasi

pengaturan

PG*

Informasi tambahan

PG* : Kelompok pengemasan

Lihat dokumen pengapalan untuk informasi transportasi tertentu.

14. Informasi Transportasi

Produk TERJUAL

Penggunaan produk dicairkan

Tidak dimaksudkan untuk

transportasi.

Kelas ADR/RID

Tidak diatur.

Kelas IMDG

Tidak diatur.

15. Informasi yang berkaitan dengan Regulasi

Regulasi tentang

lingkungan, kesehatan

dan keamanan untuk

produk tersebut

:

Produk TERJUAL

Penggunaan produk dicairkan

Sejauh diketahui tidak ada peraturan nasional

atau kedaerahan spesifik yang berlaku untuk

produk ini (termasuk bahan-bahan produk

tersebut).

Sejauh diketahui tidak ada peraturan

nasional atau kedaerahan spesifik yang

berlaku untuk produk ini (termasuk bahan-

bahan produk tersebut).

Sejarah / Riwayat

Tanggal terbitan

Informasi di atas diyakini benar sehubungan dengan formula yang digunakan untuk memproduksi produk di

negara asal. Sebagai data, standar, dan perubahan peraturan, dan ketentuan penggunaan dan penanganan

berada di luar kendali kami, TIDAK ADA GARANSI, TERSURAT MAUPUN TERSIRAT, DIBUAT SEBAGAI

KELENGKAPAN ATAU AKURASI LANJUTAN DARI INFORMASI INI.

Pemberitahuan kepada pembaca

Tanggal terbitan

sebelumnya

:

:

16. Informasi Lain

Referensi

Disiapkan oleh

:

Urusan peraturan

Tidak tersedia.

14 Mar 2013

Tidak ada validasi sebelumnya

914598-13

Halaman: 6/6

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Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Outcome of the public consultation on the draft statement on genotoxicity assessment of chemical mixtures

Outcome of the public consultation on the draft statement on genotoxicity assessment of chemical mixtures

Published on: Wed, 16 Jan 2019 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the genotoxicity assessment of chemical mixtures. The draft statement was prepared by a dedicated working group of the Scientific Committee and endorsed by the Scientific Committee for public consultation at its 89th plenary meeting of 28‐29 May 2018. The public consultation for this document was open from 26 June until 9 ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Published on: Mon, 14 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qua...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Published on: Mon, 14 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure w...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of Lactobacillus reuteri NBF‐2 (DSM 32264) as a feed additive for cats

Safety and efficacy of Lactobacillus reuteri NBF‐2 (DSM 32264) as a feed additive for cats

Published on: Fri, 11 Jan 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Lactobacillus reuteri NBF‐2 when used in feed for cats at a minimum dose of 6 × 109 colony forming units (CFU) per animal and day. The additive is a preparation of viable cells of L. reuteri DSM 32264. This species is considered by EFSA to be suitable for the qualified presum...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of Lactobacillus reuteri NBF‐1 (DSM 32203) as a feed additive for dogs

Safety and efficacy of Lactobacillus reuteri NBF‐1 (DSM 32203) as a feed additive for dogs

Published on: Fri, 11 Jan 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Lactobacillus reuteri NBF‐1 when used in feed for dogs at a minimum dose of 6 × 109 colony forming units (CFU) per animal and day. The additive is a preparation of viable cells of L. reuteri DSM 32203. This species is considered by the European Food Safety Authority to be sui...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Published on: Fri, 11 Jan 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for rabbits for fattening. HOSTAZYM® X contains endo‐1,4‐beta‐xylanase produced by a strain of Trichoderma citrinoviride and is available in liquid and solid formulations. It is authorised as a feed additive for chickens for fattening, turkeys f...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Published on: Fri, 11 Jan 2019 Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating th...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Antimicrobial resistance

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

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

3-1-2019

Dollarama recalls MONTOY Little Princess Doll

Dollarama recalls MONTOY Little Princess Doll

The plastic doll contains levels of phthalates that exceed the allowable limit and may pose a chemical hazard. Studies suggest that certain phthalates, including DEHP, may cause reproductive and developmental abnormalities in young children when soft vinyl products containing phthalates are sucked or chewed for extended periods.

Health Canada

20-12-2018

New report on adverse reactions reported with tramadol for pain relief

New report on adverse reactions reported with tramadol for pain relief

The Danish Medicines Agency has received 830 reports of suspected adverse reactions with tramadol since the medicine was marketed in March 1993. 155 of them describe symptoms of dependence. This follows from a report that has just been published. In 2017, about 265,000 individuals received treatment with tramadol in Denmark.

Danish Medicines Agency

20-12-2018

Health Canada releases test results of certain sartan drugs

Health Canada releases test results of certain sartan drugs

Health Canada has released the results of its testing of sartan drugs in Canada. Health Canada tested samples of certain sartan drugs (valsartan, candesartan, irbesartan, losartan, and olmesartan), which represent numerous products, as part of its ongoing collaborative work to address impurities found in some sartan drugs in Canada and internationally.

Health Canada

19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Published on: Tue, 18 Dec 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-12-2018

 Occupational health: aiming to take better account of multiple exposure

Occupational health: aiming to take better account of multiple exposure

Workers can potentially be exposed to numerous health risk factors through their occupations. The question of multiple exposure is a major challenge for all those active in the field of occupational health, safety and prevention. As part of the 2016-2020 National Occupational Health Plan, a review of the measures taken by the main players to address the question of multiple exposure in France and abroad is being published today. This work has helped determine the state of knowledge and the issues surroun...

France - Agence Nationale du Médicament Vétérinaire

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

6-12-2018

FDA Working with Stakeholders to Maintain Effectiveness of Livestock and Horse Dewormers

FDA Working with Stakeholders to Maintain Effectiveness of Livestock and Horse Dewormers

The U.S. Food and Drug Administration announced today that it has requested that animal drug companies voluntarily revise the labels of animal drugs intended to treat certain internal parasites in livestock and horses to add information about antiparasitic resistance.

FDA - U.S. Food and Drug Administration

6-12-2018

Bioscopen, fitnesscentra, scholierenfeesten en studentenverenigingen ook aan de slag met bescherming gehoor

Bioscopen, fitnesscentra, scholierenfeesten en studentenverenigingen ook aan de slag met bescherming gehoor

Meer plekken waar versterkte muziek is te horen, gaan actief aan de slag om het gehoor van bezoekers beter te beschermen. Poppodia, festivals en evenementen hadden al een convenant met de overheid om veilige geluidsniveaus aan te houden. Vandaag sluiten bioscopen, fitnesscentra, scholierenfeesten en studentenverenigingen zich daarbij aan. Alle betrokken partijen tekenen vandaag het Derde convenant preventie gehoorschade versterkte muziek met staatssecretaris Paul Blokhuis (VWS).

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-12-2018

January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

January 16, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

30-11-2018

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Published on: Thu, 29 Nov 2018 African swine fever (ASF) infection is circulating in Eurasia since a decade within wild boar populations without a demonstrated vector host. Further the infection was recurrently translocated by spatio‐temporal dynamics that is incompatible with wild boar movement characteristics. Management actions are required in areas affected by ASF. Control measures address areas with recent focal introduction and areas with ASF circulating several seasons or endemic occurrence. In v...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

22-11-2018

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

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

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Published on: Tue, 20 Nov 2018 The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement wi...

Europe - EFSA - European Food Safety Authority Publications

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

20-11-2018

Blokhuis neemt maatregelen om daling vaccinatiegraad te keren

Blokhuis neemt maatregelen om daling vaccinatiegraad te keren

Staatssecretaris Paul Blokhuis (VWS) wil de dalende vaccinatiegraad keren om Nederlanders beter te beschermen tegen de uitbraak van ernstige infectieziekten Hij start een zogenaamde vaccinatiealliantie waarin alle betrokken partijen (ouders, artsen, verpleegkundigen, deskundigen, etc.) hun krachten bundelen om het belang van vaccinaties op allerlei manieren duidelijker en zichtbaarder te maken. Aan onjuiste informatie over vaccinaties zal – bijvoorbeeld op sociale media - actief weerwoord worden geboden....

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

19-11-2018

Dollarama recalls MONTOY Doll and Toy Furniture Set

Dollarama recalls MONTOY Doll and Toy Furniture Set

The plastic doll and furniture toy set contains levels of phthalates that exceed the allowable limit and may pose a chemical hazard. Studies suggest that certain phthalates, including DEHP, may cause reproductive and developmental abnormalities in young children when soft vinyl products containing phthalates are sucked or chewed for extended periods.

Health Canada

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Home Hardware Stores Ltd. Recalls Benchmark Step Ladder with Tray

Home Hardware Stores Ltd. Recalls Benchmark Step Ladder with Tray

The platform on the ladder does not lock securely in place posing a potential fall hazard.

Health Canada

2-11-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation

FDA - U.S. Food and Drug Administration

31-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use

Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use

Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use.

FDA - U.S. Food and Drug Administration

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

1-2-2019


First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

Europe - EMA - European Medicines Agency

24-1-2019


Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201805

Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201805

Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201805

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2111 (Rheacell GmbH and Co. KG)

EU/3/18/2111 (Rheacell GmbH and Co. KG)

EU/3/18/2111 (Active substance: Allogeneic ABCB5-positive limbal stem cells) - Orphan designation - Commission Decision (2018)9026 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/155/18

Europe -DG Health and Food Safety

30-11-2018

.@US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

.@US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

. @US_FDA has selected 8 novel medical devices as participants in #FDA’s Innovation Challenge to address the #OpioidEpidemic by preventing and treating opioid use disorder. #FDAInnovationChallenge

FDA - U.S. Food and Drug Administration

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split i

Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split i

Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain / split influenza virus, inactivated containing antigens equivalent to the B-like strain, decision type: , therapeutic area: , PIP number: P/0155/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Treprostinil, decision type: , therapeutic area: , PIP number: P/0144/2018

Opinion/decision on a Paediatric investigation plan (PIP): Treprostinil, decision type: , therapeutic area: , PIP number: P/0144/2018

Opinion/decision on a Paediatric investigation plan (PIP): Treprostinil, decision type: , therapeutic area: , PIP number: P/0144/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/17/1962 (MWB Consulting S.A.R.L.)

EU/3/17/1962 (MWB Consulting S.A.R.L.)

EU/3/17/1962 (Active substance: Humanised Fc-engineered monoclonal antibody against CD19) - Transfer of orphan designation - Commission Decision (2018)7815 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/155/17/T/01

Europe -DG Health and Food Safety

9-11-2018

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks.  http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4 pic.twitter.com/o2I1dYUQCx

Recent Ebola outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of today’s EUA is an important step in addressing these outbreaks. http://go.usa.gov/xPvs4  pic.twitter.com/o2I1dYUQCx

FDA - U.S. Food and Drug Administration