Apo-Capto

Maklumat utama

  • Nama dagangan:
  • Apo-Capto Tablet
  • Perubatan domain:
  • Manusia
  • Jenis perubatan:
  • Ubat Allopathic

Dokumen

Penyetempatan

  • Terdapat dalam:
  • Apo-Capto Tablet
    Malaysia
  • Bahasa:
  • Bahasa Melayu

Maklumat lain

Status

  • Sumber:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Nombor kebenaran:
  • MAL 1998734
  • Kemaskini terakhir:
  • 29-05-2018

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

APO-CAPTO TABLET

Captopril (12.5mg, 25mg)

1

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Apakah yang ada pada risalah ini

Apakah kegunaan Apo-Capto

Bagaimana Apo-Capto berfungsi

Sebelum menggunakan Apo-Capto

Cara menggunakan Apo-Capto

Semasa menggunakan Apo-Capto

Kesan-kesan sampingan

Cara penyimpanan dan pelupusan

Apo-Capto

Maklumat lanjut

Pengilang dan Pemegang

Pendaftaran Produk

Tarikh kemaskini RiMUP

Apa kegunaan Apo-Capto

Captopril adalah perencat ACE. ACE

bermaksud "

angiotensin converting

enzyme

".

Captopril diindikasi untuk rawatan

hipertensi

essential

(tekanan darah tinggi

tanpa sebab yang dikenal pasti) atau

tekanan darah tinggi

renovascular

(tekanan darah tinggi yang disebabkan

oleh tindak balas hormon buah pinggang

terhadap penyempitan saluran darah).

Apo-Capto diindikasi untuk kegagalan

jantung yang tidak bertindak balas

secukupnya kepada atau tidak boleh

dikawal oleh diuretik konvensional dan

terapi digitalis.

Bagaimana Apo-Capto berfungsi

Captopril berfungsi dengan menyekat

enzim dalam badan yang diperlukan

untuk menghasil sejenis bahan yang

menyebabkan penyempitan saluran

darah. Akibatnya, saluran darah menjadi

kurang tegang dan ini merendahkan

tekanan darah.

Sebelum menggunakan Apo-Capto

- Bila tidak boleh menggunakan

Jangan gunakan captopril jika anda

hamil. Berhenti menggunakan

captopril dan beritahu doktor dengan

segera jika anda hamil. Captopril boleh

menyebabkan kecederaan atau

kematian kepada bayi dalam

kandungan jika ia diambil semasa

trimester kedua atau ketiga. Gunakan

kawalan kelahiran yang berkesan

semasa mengambil ubat ini. Captopril

boleh menyerap masuk ke dalam susu

ibu dan mungkin boleh membahayakan

bayi. Jangan menyusu anak semasa

pengambilan captopril.

- Sebelum mula mengguna

Jangan memgambil ubat ini jika anda

alah kepada captopril atau mana-mana

perencat ACE yang lain.

Untuk memastikan anda boleh

mengambil captopril secara selamat,

beritahu doktor jika anda mempunyai

keadaan-keadaan seperti berikut:

Penyakit buah pinggang (atau jika

anda bergantung kepada dialisis);

Penyakit hati;

Penyakit jantung atau kegagalan

jantung kongestif;

Angioedema

(kebengkakan bawah

kulit);

kencing manis;

Penyakit tisu penghubung seperti

sindrom

Marfan

, sindrom

Sjogren

lupus

scleroderma

, atau artritis

reumatoid.

- Jika mengambil ubat-ubat lain

Beritahu doktor anda tentang semua

ubat-ubatan lain yang anda gunakan,

terutama sekali:

litium;

Suplemen kalium;

Garam gantian yang mengandungi

kalium;

Ubat-ubatan yang boleh meluaskan

saluran darah;

aspirin atau NSAID lain-lain (ubat

anti-radang yang bukan steroid)

Diuretik (pil air).

Beritahu kepada doktor mengenai

semua ubat yang anda gunakan.

Cara menggunakan Apo-Capto

- Berapa banyak harus digunakan

Dos yang dicadangkan untuk orang

dewasa bermula dari 6.25 mg 3 kali

sehari hingga 150 mg 3 kali setiap hari

seperti mana yang ditetapkan oleh

doktor anda. Ambil betul-betul seperti

yang diarahkan oleh doktor anda.

- Bila perlu digunakan

Apo-Capto harus diambil 1 jam

sebelum makan.

- Berapa lama perlu digunakan

Jangan berhenti mengambil Apo-Capto

tanpa terlebih dahulu berbincang

dengan doktor anda. Menghentikan

pengambilan Apo-Capto secara tiba-

tiba mungkin boleh memburukkan lagi

keadaan anda.

-Jika terlupa menggunakan

Mengambil dos yang terlepas secepat

mungkin bila anda teringat.

Jika ia sudah hampir masa untuk dos

seterusnya, terus ambil dos seterusnya

mengikut jadual masa yang ditetapkan

tanpa menghirau dos yang terlepas.

Jangan gandakan dos untuk ubat ini.

- Jika mengambil berlebihan (terlebih

dos)

Jika dos berlebihan berlaku, dalam

semua kes, terapi dengan Apo-Capto

harus dihentikan dengan serta-merta

dan anda perlu menghubungi doktor

atau pergi ke bahagian kecemasan di

hospital yang terdekat.

Penggunaan secara berlebihan boleh

mengakibatkan hipotensi (penurunan

tekanan darah).

Semasa menggunakan Apo-Capto

Perkara yang perlu dilakukan

Ambil ubat anda mengikut arahan

doktor.

Maklumkan kepada semua doktor,

doktor gigi dan ahli farmasi yang

merawat anda bahawa anda sedang

menggunakan Apo-Capto.

Beritahu doktor anda dengan segera

jika anda menjadi hamil semasa

menggunakan ubat ini.

- Perkara yang tidak boleh dilakukan

Jangan berhenti menggunakan ubat ini

kecuali diarahkan oleh doktor anda.

2

Risalah Maklumat Ubat untuk Pengguna (RiMUP)

Jangan mula mengambil sebarang ubat

baru tanpa berbincang dengan doktor

atau ahli farmasi anda.

Jangan berkongsi Apo-Capto dengan

sesiapa, walaupun mereka mempunyai

simptom atau penyakit yang sama.

- Perkara yang perlu diberi perhatian

Jangan gunakan garam gantian atau

suplemen kalium semasa mengambil

captopril, melainkan jika doktor

mengarahkan anda.

Keadaan-keadaan yang mungkin boleh

menyebabkan tekanan darah yang

sangat rendah termasuk: muntah, cirit-

birit, banyak berpeluh, sakit jantung,

dialisis, diet garam yang rendah, atau

mengambil diuretik (pil air). Ikut

arahan doktor mengenai jenis dan

jumlah cecair anda perlu minum

semasa mengambil captopril. Beritahu

doktor jika anda mempunyai penyakit

yang berpanjangan yang menyebabkan

cirit-birit atau muntah-muntah.

Kesan sampingan

Hubungi doktor anda serta-merta jika

mengalami kesan sampingan yang serius

seperti berikut semasa mengambil

captopril:

Rasa ringan kepala, pengsan;

Membuang air kecil lebih atau

kurang daripada biasa, atau tidak

sama sekali;

Demam;

Kulit pucat, rasa ringan kepala atau

kesukaran bernafas, kadar denyutan

jantung yang cepat, masalah

menumpukan perhatian;

Mudah lebam, pendarahan luar biasa

(hidung, mulut, faraj, atau rektum),

bintik ungu atau merah di bawah

kulit anda;

Degupan jantung yang cepat,

berdebar-debar, atau tidak sekata;

Sakit dada;

Bengkak, berat badan naik dengan

cepat

Kesan sampingan Captopril yang kurang

serius mungkin termasuk:

batuk;

Kehilangan rasa sensasi, hilang

selera makan;

Pening, mengantuk, sakit kepala;

Masalah tidur (insomnia);

Mulut kering, kudis dalam mulut

anda atau pada bibir anda;

Loya, cirit-birit, sembelit;

Kulit gatal-gatal atau ruam ringan.

Ini bukan senarai kesan sampingan yang

lengkap dan kemungkinan terdapat kesan

sampingan yang lain.

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

Apo-Capto

- Penyimpanan

Anda diingatkan supaya menyimpan

Apo-Capto dan semua ubat-ubat lain

jauh daripada kanak-kanak.

Jangan gunakan ubat ini selepas tarikh

bulan dan tahun seperti mana yang

ditulis pada EXP di bekas.

Simpan Apo-Capto pada suhu bilik

terkawal (antara 15°- 25 ° C). Lindungi

daripada kelembapan.

- Pelupusan

Tanya ahli farmasi apa yang perlu

dilakukan dengan baki tablet jika doktor

anda mengarah anda berhenti

mengambilnya, atau telah lupus tarikh

penggunaannya.

Maklumat Lanjut

-Rupa dan warna produk

Apo-Capto 12.5mg: Tablet putih,

berbentuk kapsul, permukaan yang

rata, dengan tepi yang serong,

dibahagi dua di kedua-dua belah,

"APO" di satu permukaan dan "12.5"

di sebelah permukaan yang lain.

Apo-Capto 25mg: tablet putih, empat

segi, dwicembung, satu permukaan

dibahagikan kepada empat bahagian

yang sama, "APO" diukir atas "25" di

sebelah permukaan yang lain.

- Bahan-bahan Kandungan

Bahan Aktif: Captopril

Bahan tidak aktif:

Lactose

monohydrate, microcrystalline

cellulose, magnesium stearate,

croscarmellose sodium

colloidal

silicon dioxide.

- Nombor MAL

Apo-Capto 12.5mg

MAL 19987341AR

Apo-Capto 25mg

MAL 19987340AR

Pengilang

Apotex Inc.

150 Signet Drive

Weston Toronto Ontario

M9L 1T9 Canada

Pemegang Pendaftaran Produk

Pharmaforte (M) Sdn Bhd

2, Jalan PJU 3/49

Sunway Damansara

47810 Petaling Jaya

Tarikh Kemaskini RiMUP

4/12/2014

Nombor siri

BPFK(R4/1)031214/00070

21-3-2019

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Published on: Wed, 20 Mar 2019 The additive contains viable spores of two strains of Bacillus amyloliquefaciens and a single strain of Bacillus subtilis and is intended to be used with pigs for fattening and minor porcine species at a minimum inclusion level of 1.5 × 108 colony forming units (CFU)/kg complete feedingstuffs. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strains to be establ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Published on: Tue, 19 Mar 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 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 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 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Pest categorisation of Phymatotrichopsis omnivora

Pest categorisation of Phymatotrichopsis omnivora

Published on: Tue, 12 Mar 2019 The Panel on Plant Health performed a pest categorisation of Phymatotrichopsis omnivora, the causal agent of Phymatotrichum root rot of more than 2,000 dicotyledonous plant species, for the EU. The pest is listed as Trechispora brinkmannii in Annex IAI of Directive 2000/29/EC. P. omnivora is a well‐defined fungal species and reliable methods exist for its detection and identification. It is present in south‐western USA, northern Mexico, Libya and Venezuela. The pest is not...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Pest survey card on Popillia japonica

Pest survey card on Popillia japonica

Published on: Wed, 06 Mar 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from 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 Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Published on: Mon, 04 Mar 2019 Beltherm MP/ML contains endo-1,4-beta-xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Published on: Fri, 01 Mar 2019 Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and is intended to be used as a zootechnical additive for poultry species. The safety and efficacy of the additive have been evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) in 2017. In that assessment, the additive and the production strain, a genetically modified strain of Bacillus subtilis, were characterised in full. No viable cells of the production strain were detecte...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

Published on: Fri, 01 Mar 2019 The additive Calsporin® is a preparation of viable spores of Bacillus subtilis DSM 15544, at a minimum declared concentration of 1 × 1010 colony forming units (CFU)/g additive. The additive is authorised as a zootechnical additive (functional group: gut flora stabiliser) for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds, laying hens and ornamental fish, dogs, in sows and in suckli...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Published on: Fri, 25 Jan 2019 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6‐methylcoumarin [FL‐no: 13.012] and 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023] the concern for genotoxicity was ruled out. 6‐Methylc...

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

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

Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen

Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen

Mojave Foods Corporation is initiating a voluntary recall of El Guapo Chile Habanero and Chile Pasilla-Ancho pouches due to an unlabeled peanut allergen.

FDA - U.S. Food and Drug Administration

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

Apo-Prednisone 5 mg Tablet (2018-12-18)

Health Canada

11-12-2018

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

The recalled product does not have proper consumer chemical hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

7-8-2018

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Mojave Foods Corporation is initiating a voluntary recall of four sizes of El Guapo Jamaica Hibiscus Flower packages in flexible packaging due to an unlabeled peanut allergen

FDA - U.S. Food and Drug Administration

24-7-2018

Opinion/decision on a Paediatric investigation plan (PIP):    Penthrox, Methoxyflurane, Therapeutic area: Pain

Opinion/decision on a Paediatric investigation plan (PIP): Penthrox, Methoxyflurane, Therapeutic area: Pain

Europe - EFSA - European Food Safety Authority EFSA Journal

9-6-2018

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk

Caito Foods is voluntarily recalling fresh cut watermelon, honeydew melon, cantaloupe and fresh-cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis, because these products have the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

4-2-2019

Xaluprine (Nova Laboratories Ireland Limited)

Xaluprine (Nova Laboratories Ireland Limited)

Xaluprine (Active substance: Mercaptopurine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)846 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002022/T/0020

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

4-2-2019

Stalevo (Orion Corporation)

Stalevo (Orion Corporation)

Stalevo (Active substance: Levodopa,carbidopa,entacapone) - Centralised - Yearly update - Commission Decision (2019)847 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Gadolinium, [α3,α6,α9-tris[3-[(2,3-dihydroxypropyl)amino]-3-oxopropyl]-3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-κN3,κN6,κN9,κN15,κO3,κO6,κO9]-(P03277), dec

Opinion/decision on a Paediatric investigation plan (PIP): Gadolinium, [α3,α6,α9-tris[3-[(2,3-dihydroxypropyl)amino]-3-oxopropyl]-3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-κN3,κN6,κN9,κN15,κO3,κO6,κO9]-(P03277), dec

Opinion/decision on a Paediatric investigation plan (PIP): Gadolinium, [α3,α6,α9-tris[3-[(2,3-dihydroxypropyl)amino]-3-oxopropyl]-3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-κN3,κN6,κN9,κN15,κO3,κO6,κO9]-(P03277), decision type: , therapeutic area: , PIP number: P/0323/2018

Europe - EMA - European Medicines Agency

18-12-2018


Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Europe - EMA - European Medicines Agency

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

22-11-2018

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Active substance: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione) - Transfer of orphan designation - Commission Decision (2018)7813 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000001966

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Active substance: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate) - Transfer of orphan designation - Commission Decision (2018)5038 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/06/T/03

Europe -DG Health and Food Safety

10-7-2018

Corbilta (Orion Corporation)

Corbilta (Orion Corporation)

Corbilta (Active substance: levodopa / carbidopa / entacapone) - Centralised - Renewal - Commission Decision (2018)4468 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2785/R/15

Europe -DG Health and Food Safety

15-5-2018

Fevaxyn Pentofel (Zoetis Belgium S.A.)

Fevaxyn Pentofel (Zoetis Belgium S.A.)

Fevaxyn Pentofel (Active substance: Not available) - Centralised - Yearly update - Commission Decision (2018)2990 of Tue, 15 May 2018

Europe -DG Health and Food Safety