Arixtra

Maklumat utama

  • Nama dagangan:
  • Arixtra® 12.5 mg/ml Solution For Injection
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Arixtra® 12.5 mg/ml Solution For Injection
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL07081508
  • Kemaskini terakhir:
  • 31-08-2017

Risalah Maklumat Pesakit: ciri produk - komposisi, petunjuk, kesan sampingan, dos, interaksi, tindak balas buruk, kehamilan, penyusuan

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

ARIXTRA

®

12.5 MG/ML SOLUTION FOR

INJECTION

Fondaparinux sodium (12.5 mg/ ml)

Apakah yang ada pada risalah

ini

Apakah kegunaan ARIXTRA

Bagaimana ARIXTRA

berfungsi

Sebelum mengambil

ARIXTRA

Cara menggunakan

ARIXTRA

Semasa menggunakan

ARIXTRA

Kesan-kesan sampingan

Cara penyimpanan dan

pelupusan ARIXTRA

Maklumat Lanjut

Pengilang dan Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apakah kegunaan ARIXTRA

Arixtra digunakan untuk:

menghalang pembentukan

darah beku di dalam saluran

darah pada kaki atau paru-

paru selepas pembedahan

ortopedik (seperti

pembedahan pinggul atau

lutut) atau pembedahan

bahagian abdomen.

merawat darah beku dalam

saluran darah yang mendalam

di kaki (trombosis vena

dalam) atau paru-paru

(trombosis pulmonari)

Bagaimana ARIXTRA

berfungsi

Arixtra adalah ubat yang

membantu untuk mengelakkan

pembekuan darah daripada

terbentuk dalam saluran

darah (thrombosis), atau

merawat darah beku jika mereka

telah terbentuk (agen

antitrombotik).

Ini berlaku

dengan menghentikan faktor

pembekuan dipanggil Xa ("ten-

A") daripada berfungsi di dalam

darah.

Sebelum mengambil

ARIXTRA

Bila tidak boleh mengambil

Jangan gunakan Arixtra:

Jika anda

alah

(hipersensitif) kepada

fondaparinux sodium atau

kepada mana-mana bahan-

bahan lain Arixtra

jika anda mengalami

pendarahan berlebihan

jika anda mempunyai

jangkitan jantung berbakteria

jika anda mempunyai

kerosakan buah pinggang

yang teruk

Semak dengan doktor anda jika

anda fikir mana-mana ini

mungkin berkaitan dengan anda.

Arixtra tidak boleh diberikan

kepada wanita hamil melainkan

ia jelas diperlukan.

Jika anda

hamil, atau berfikir anda

mungkin hamil, beritahu doktor

anda.

Penyusuan bayi adalah tidak

digalakkan semasa rawatan

dengan Arixtra.

Sebelum mula mengambil

Sebelum anda diberi Arixtra

doktor anda perlu tahu:

jika anda mempunyai risiko

pendarahan yang tidak

terkawal (haemorrhage)

termauk:

ulser perut

gangguan pendarahan

pendarahan baru-baru ini di

dalam otak(pendarahan

intracranial)

pembedahan baru-baru ini

ke atas otak, tulang

belakang atau mata

jika anda mempunyai masalah

pembekuan darah, atau sejarah

pengurangan dalam bilangan

sel-sel yang diperlukan untuk

pembekuan

selepas rawatan

dengan heparin

(Heparin

Induced Thrombocytopenia

jika anda mempunyai penyakit

hati

jika anda mempunyai penyakit

buah pinggang

jika anda berusia 75 tahun

atau lebih tua

jika berat anda kurang

daripada 50 kg.

Semak dengan doktor anda jika

anda fikir mana-mana ini

mungkin berkaitan dengan anda.

Jika mengambil ubat-ubat lain

Beritahu doktor atau ahli farmasi

anda jika anda mengambil

sebarang ubat-ubatan lain, jika

anda mengambil apa-apa baru-

baru ini, atau jika anda mula

mengambil ubat-ubatan baru.

termasuk ubat-ubatan yang anda

beli tanpa preskripsi.

Sesetengah

ubat-ubatan lain boleh

mengubah cara Arixtra berfungsi

atau membuat ia lebih

berkemungkinan untuk anda

mendapat kesan sampingan

seperti pendarahan.

Cara menggunakan

ARIXTRA

Berapa banyak harus

digunakan

Dos Arixtra bergantung kepada

berat badan anda. Suntik Arixtra

pada waktu yang sama setiap

hari.

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Berat badan

anda

Dos yang

biasa

Di bawah 50 kg

5 mg sekali

sehari

Antara 50 kg

dan 100 kg

7.5 mg sekali

sehari

Lebih 100 kg

10 mg sekali

sehari.

Arixtra diberikan melalui

suntikan di bawah kulit

(subcutaneously) ke dalam

lapisan kulit di bahagian bawah

abdomen.

Picagari ini telah diisi

dengan dos tepat yang anda

perlukan.

Langkah-langkah penggunaan

Bahagian-bahagian picagari:

Penutup jarum

Pelocok

Pemegang

Penutup keselamatan

Arahan untuk penggunaan

1. Cuci tangan anda dengan

sabun dan air dan keringkan

dengan tuala.

2. Keluarkan alat penyuntik

daripada karton dan pastikan:

Ia tidak melepasi tarikh luput

solusi adalah jernih dan tidak

berwarna dan tidak

mengandungi sebarang bahan

lain

picagari itu belum dibuka atau

rosak.

3. Duduk atau baring dalam

kedudukan yang selesa.

Pilih tempat pada bahagian

bawah perut, sekurang-

kurangnya 5 cm di bawah pusat

anda (gambar A)

Gambar A

Gilirkan bahagian kiri dan kanan

kawasan bawah abdomen untuk

setiap suntikan.

Ini akan

membantu untuk mengurangkan

rasa tidak selesa pada tempat

suntikan.

Jika suntikan pada kawasan

bawah abdomen adalah mustahil

untuk dilakukan, sila berjumpa

jururawat atau doktor anda untuk

mendapatkan nasihat.

4. Bersihkan kawasan suntikan

dengan pengelap beralkohol.

5. Buka penutup jarum, dengan

terlebih dahulu

memusingkannya (gambar B1)

dan kemudian menariknya

secara tegak dari alat penyuntik

(gambar B2).

gambar B1

Gambar B2

Buang penutup jarum tersebut.

Nota penting:

Jangan sentuh jarum atau

membenarkan ia menyentuh

mana-mana permukaan sebelum

suntikan.

Ia adalah biasa untuk melihat

gelembung udara kecil di dalam

picagari ini.

Jangan cuba untuk

membuang gelembung udara ini

sebelum membuat suntikan -

anda mungkin kehilangan sedikit

ubat jika anda lakukan.

6. Dengan perlahan-lahan cubit

kulit yang telah dibersihkan

untuk membuat lipatan. Pegang

lipatan tersebut di antara ibu jari

dan jari telunjuk semasa

melakukan suntikan (gambar C).

Gambar C

7. Pegang alat penyuntik dengan

kemas pada tempat pemegang.

Masukkan penuh jarum pada

sudut yang betul ke dalam

lipatan kulit (gambar D).

Gambar D

8. Suntik semua kandungan

picagari dengan menekan ke

bawah pada pelocok sehingga

habis (gambar E).

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Gambar E

9. Lepaskan pelocok dan secara

automatik jarum akan keluar

daripada kulit dan kembali ke

penutup keselamatan di mana ia

akan terkunci secara kekal

(gambar F).

Gambar F

Jangan buang picagari yang

telah digunakan bersama sisa

bahan rumah.

Lupuskannya

sebagaimana diarahkan doktor

atau ahli farmasi anda.

Bila perlu digunakan

Sentiasa gunakan Arixtra seperti

mana yang doktor anda telah

arahkan.

Semak dengan doktor

atau ahli farmasi jika anda tidak

pasti.

Berapa lama perlu digunakan

Tempoh rawatan anda akan

bergantung kepada keadaan

anda.

Doktor anda akan

menasihati anda.

Jangan berhenti mengambil

Arixtra tanpa nasihat.

Jika anda

memberhentikan rawatan

sebelum doktor anda arahkan,

darah beku tidak boleh dirawat

dengan betul dan anda juga

mungkin akan berisiko tinggi

untuk mendapat darah beku baru

dalam vena kaki anda atau di

dalam paru-paru.

Hubungi

doktor atau ahli farmasi anda

sebelum berhenti.

Jika terlupa menggunakan

Jika anda terlupa untuk

mengambil satu dos, suntik

sebaik sahaja anda

teringat.

Jangan menyuntik dos

yang berganda untuk dos yang

tertinggal.

Jika anda tidak pasti

apa yang perlu dilakukan, tanya

doktor atau ahli farmasi.

Jika mengambil berlebihan

(terlebih dos)

Jika anda secara tidak sengaja

menggunakan Arixtra terlalu

banyak, hubungi doktor atau ahli

farmasi anda untuk mendapatkan

nasihat secepat mungkin, kerana

anda mempunyai risiko tinggi

untuk mendapat pendarahan.

Semasa menggunakan

ARIXTRA

Perkara yang perlu dilakukan

Semak dengan doktor atau ahli

farmasi sebelum mengambil

ubat anda dan ambil seperti yang

ditetapkan oleh doktor anda.

Perkara yang tidak boleh

dilakukan

Ubat ini telah ditetapkan untuk

anda.

Jangan serahkan kepada

orang lain.

Ini boleh

menjejaskan mereka, walaupun

simptom-simptom mereka

adalah sama seperti anda.

Jangan menyuntik Arixtra ke

dalam otot.

Perkara yang perlu diberi

perhatian

Arixtra belum diuji secukupnya

pada kanak-kanak dan remaja di

bawah umur 17 tahun.

Penutup jarum picagari

mungkin

mengandungi lateks.

Beritahu doktor anda jika anda

alah kepada lateks.

Kesan-kesan sampingan

Seperti semua ubat-ubatan,

Arixtra boleh menyebabkan

kesan sampingan, walaupun

bukan semua orang

mengalaminya.

Kesan-kesan sampingan biasa

Ini boleh memberi kesan

sehingga 1 dalam 10 orang:

pendarahan (contohnya

daripada kawasan

pembedahan, lebam yang

berlebihan, darah dalam air

kencing dan najis, hidung

berdarah, jarang untuk

pendarahan berlaku di dalam

dan sekitar otak atau organ-

organ dalaman)

bengkak

(Edema).

Kesan-kesan sampingan yang

mungkin muncul dalam ujian

darah anda:

anemia (pengurangan dalam

bilangan sel-sel darah merah).

Kesan-kesan sampingan tidak

biasa

Ini boleh memberi kesan

sehingga 1 dalam 100 orang:

sakit kepala

rasa sakit (rasa loya), muntah

ruam, kulit gatal

lelehan dari luka pembedahan

demam

pembekuan darah yang tidak

normal.

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Kesan sampingan tidak biasa

yang mungkin muncul dalam

ujian darah anda:

pengurangan atau peningkatan

dalam bilangan platelet (sel-

sel darah yang diperlukan

untuk pembekuan darah)

peningkatan dalam beberapa

bahan kimia (enzim) yang

dihasilkan oleh hati.

Kesan-kesan sampingan jarang

Ini boleh memberi kesan

sehingga 1 dalam 1,000 orang:

tindak balas alahan

keresahan, kekeliruan

pengsan, pening, tekanan

darah rendah, sensasi

berputar (vertigo)

mengantuk, keletihan

kemerahan kulit

batuk, sesak nafas

sakit dada, sakit kaki

cirit-birit, sembelit

sakit perut, ketidakhadaman

jangkitan luka

kerengsaan pada tempat

suntikan.

Kesan sampingan jarang berlaku

mungkin muncul dalam ujian

darah anda:

Peningkatan bilirubin (bahan

yang dihasilkan oleh hati)

kalium rendah.

Beritahu doktor atau ahli farmasi

anda jika apa-apa kesan

sampingan yang disenaraikan

menjadi teruk atau

menyukarkan, atau jika anda

perasan apa-apa kesan

sampingan yang tidak

disenaraikan di dalam risalah ini.

Anda boleh melaporkan

sebarang kesan sampingan atau

kesan advers ubat kepada Pusat

Pemantauan Kesan Advers Ubat

Kebangsaan melalui No. Tel:

03-78835550, atau laman web

portal.bpfk.gov.my (Consumers

Reporting)

Cara penyimpanan dan

pelupusan ARIXTRA

Penyimpanan

Jauhkan dari jangkauan dan

penglihatan kanak-kanak.

Jangan membekukan.

Jangan gunakan Arixtra:

selepas tarikh luput

dinyatakan pada label dan

karton

jika anda notis mana-mana

bahan lain dalam solusi, atau

jika solusi itu berubah warna

sekiranya anda dapati alat

penyuntik rosak

jika anda telah membuka

picagari dan anda tidak

menggunakannya serta merta.

Pelupusan

Jika anda mempunyai apa-apa

alat suntikan yang tidak diingini,

jangan buang ia ke dalam

sampah isi rumah. Tanya doktor

atau ahli farmasi anda untuk

mendapatkan nasihat tentang

bagaimana untuk melupuskan

mana-mana jarum suntikan anda

tidak perlu. Ini akan membantu

melindungi alam sekitar.

Maklumat lanjut

Rupa dan warna produk

Solusi yang boleh disuntik ini

adalah steril, bebas pengawet,

jernih dan tidak berwarna ke

sedikit kuning.

Ia dibekalkan dalam picagari

yang sudah diisi dan untuk

sekali guna, dipasang dengan

sistem keselamatan automatik

untuk membantu mencegah

daripada tercucuk jarum selepas

digunakan.

Bahan-bahan kandungan

Bahan aktif

Setiap picagari mengandungi 5.0

mg fondaparinux sodium dalam

0.4 ml solusi untuk suntikan atau

7.5mg fondaparinux sodium

dalam 0.6 ml solusi untuk

suntikan.

Bahan tidak aktif

Sodium chloride, hydrochloric

acid or sodium hydroxide for pH

adjustment as necessary, water

for injection.

Nombor MAL

MAL07081508A

Pengilang

Aspen Notre Dame De

Bondeville

1, Rue De L’Abbaye

76960

Notre Dame De Bondeville

France

Pemegang Pendaftaran

Produk

Aspen Medical Products

Malaysia Sdb Bhd

Unit 1302A, Level 13A, Uptown

1, 1 Jalan SS21/58, Damansara

Uptown, 47400 Petaling Jaya,

Selangor, Malaysia

Tarikh kemaskini RiMUP

22/07/2015

Nombor Siri

BPFK(R4/1)220715/00217

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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

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

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

15-3-2019


Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Active substance: Treprostinil sodium (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)1741 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004330

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/08/554 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/08/554 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/08/554 (Active substance: Beraprost sodium (modified release tablet)) - Transfer of orphan designation - Commission Decision (2019)1354 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003232

Europe -DG Health and Food Safety

4-2-2019

Elmiron (bene-Arzneimittel GmbH)

Elmiron (bene-Arzneimittel GmbH)

Elmiron (Active substance: pentosan polysulfate sodium) - Centralised - Yearly update - Commission Decision (2019)848 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Europe - EMA - European Medicines Agency

24-1-2019


Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Europe - EMA - European Medicines Agency

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

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

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18

Europe -DG Health and Food Safety

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Active substance: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-beta-D-galactopyranosyl]-4-O-(a-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide) - Transfer of orphan designation - Commission Decision (2018)7836 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/13/T/01

Europe -DG Health and Food Safety

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency