Sulfarlem S 25

Hauptinformation

  • Handelsname:
  • Sulfarlem S 25 Dragees
  • Darreichungsform:
  • Dragees
  • Zusammensetzung:
  • anetholtrithionum 25 mg, color.: E 110, E 124, excipiens pro compresso obducto.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Sulfarlem S 25 Dragees
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Zur Anregung der Speichelsekretion

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 37234
  • Berechtigungsdatum:
  • 19-07-1973
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Patienteninformation

Transferiert von RECORDATI SA

Sulfarlem S25®

Recordati AG

Was ist Sulfarlem S25 und wann wird es angewendet?

Sulfarlem S25 beseitigt oder beugt vor Mundtrockenheit, welche unter anderem durch

medikamentöse oder radiologische Behandlungen hervorgerufen werden kann.

Sulfarlem S25 erleichtert die Fortsetzung dieser Behandlungen und vermeidet

Mundtrockenheitsprobleme, welche bei Langzeittherapien oft auftreten.

Sulfarlem S25 wird vor allem bei Speichelinsuffizienz verwendet, welche durch einige Medikamente

verursacht oder bei radiologischer Therapie beobachtet wird, bei gewissen Krankheiten oder bei

älteren Patienten auftritt.

Sulfarlem S25 kann auch zur Behandlung der verminderten Tränenflüssigkeit verwendet werden.

Wann darf Sulfarlem S25 nicht angewendet werden?

Sulfarlem S25 darf bei Verschluss der Gallenwege oder schweren Leberfunktionsstörungen nicht

verwendet werden.

Wann ist bei der Einnahme/Anwendung von Sulfarlem S25 Vorsicht geboten?

Patientinnen und Patienten, die auf Azofarbstoffe, Acetylsalicylsäure sowie Rheuma- und

Schmerzmittel (Prostaglandinhemmer) überempfindlich reagieren, sollen Sulfarlem S25 nicht

anwenden.

Informieren Sie Ihren Arzt, Apotheker, bzw. Ihre Ärztin oder Apothekerin, wenn Sie an anderen

Krankheiten leiden, Allergien haben oder andere Arzneimittel (auch selbst gekaufte!) einnehmen

oder äusserlich anwenden!

Darf Sulfarlem S25 während einer Schwangerschaft oder in der Stillzeit eingenommen/angewendet

werden?

Grundsätzlich sollen Arzneimittel während der Schwangerschaft und in der Stillzeit mit grösster

Zurückhaltung und nur auf Anweisung des Arztes eingenommen werden.

Wie verwenden Sie Sulfarlem S25?

Gemäss Anweisungen Ihres Arztes.

Im Allgemeinen 3 Dragées täglich (1 vor jeder Mahlzeit).

Die Behandlung kann sowohl ununterbrochen als auch mit einer Pause von 5 Tagen pro Monat

durchgeführt werden.

Die optimale therapeutische Wirkung tritt allmählich nach einigen Tagen ein.

Die Anwendung und Sicherheit von Sulfarlem S25 Dragées bei Kindern und Jugendlichen ist bisher

nicht geprüft worden und darf von diesen nicht eingenommen werden.

Halten Sie sich an die in der Packungsbeilage angegebene oder vom Arzt oder der Ärztin

verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, so

sprechen Sie mit Ihrem Arzt oder Apotheker bzw. mit Ihrer Ärztin oder Apothekerin.

Welche Nebenwirkungen kann Sulfarlem S25 haben?

Folgende Nebenwirkungen können bei der Einnahme von Sulfarlem S25 auftreten:

Kann Überempfindlichkeitsreaktionen der Haut und Atmungsorgane auslösen, insbesondere bei

Patientinnen und Patienten mit Asthma, Nesselfieber (chronischer Urtikaria) oder mit

Überempfindlichkeit auf Acetylsalicylsäure und andere Rheuma- und Schmerzmittel.

Vereinzelte leichte Fälle, hauptsächlich gastrointestinal, oft leichter Durchfall, welche mit einer

vorübergehenden Anpassung der Dosierung verschwinden.

Die Harnverfärbung ist normal und sollte Sie nicht beunruhigen.

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder

Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Was ist ferner zu beachten?

Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet

werden.

Aufbewahrung bei Raumtemperatur (15–25 °C).

Arzneimittel ausser Reichweite von Kindern aufbewahren!

Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ärztin oder Apothekerin. Diese

Personen verfügen über die ausführliche Fachinformation.

Was ist in Sulfarlem S25 enthalten?

Wirkstoff: 1 Dragée enthält 25 mg Anetholtrithionum.

Hilfsstoffe: Farbstoffe Gelborgane S (E110) und Ponceau 4 R (E124), Excipiens pro Dragée.

Zulassungsnummer

37'234 (Swissmedic).

Wo erhalten Sie Sulfarlem S25? Welche Packungen sind erhältlich?

In Apotheken ohne ärztliche Verschreibung.

Packung zu 60 Dragées.

Zulassungsinhaberin

Recordati AG, 6340 Baar.

Diese Packungsbeilage wurde im April 2008 letztmals durch die Arzneimittelbehörde (Swissmedic)

geprüft.

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

18-3-2019

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC.

FDA - U.S. Food and Drug Administration

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

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

26-2-2019

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Published on: Mon, 25 Feb 2019 No abstract available. © European Food Safety Authority, 2015 Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

21-2-2019

Vetmedin 1.25 mg ad us. vet., Kautabletten

Vetmedin 1.25 mg ad us. vet., Kautabletten

● Änderung Text: "Vorsichtsmassnahmen"

Institut für Veterinärpharmakologie und toxikologie

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

26-1-2019

Guidelines for reporting molecular typing data through EFSA's Data Collection Framework

Guidelines for reporting molecular typing data through EFSA's Data Collection Framework

Published on: Fri, 25 Jan 2019 The European Food Safety Authority (EFSA) received the mandate from the European Commission (EC), in accordance with Article 31 of Regulation (EC) No. 178/2002, to collect data on the molecular testing of food‐borne pathogens such as Salmonella, Listeria monocytogenes and Shiga toxin‐producing Escherichia coli (STEC) from food, feed, animals and the related environment, to contribute to the epidemiological investigations of food‐borne outbreaks and to the identification of...

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

26-1-2019

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Published on: Fri, 25 Jan 2019 Based on the risk assessment of genetically modified plants, according to Implementing Regulation (EU) No 503/201321 “In cases when known functional aspects of the newly expressed protein or structural similarity to known strong adjuvants may indicate possible adjuvant activity, the applicant shall assess the possible role of these proteins as adjuvants”. To further investigate the topic, an EFSA procurement was launched requesting a comprehensive literature review and cri...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Overview of available toxicity data for calystegines

Overview of available toxicity data for calystegines

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

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-3-2019


Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Europe - EMA - European Medicines Agency

13-3-2019

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2065 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2644/T/25

Europe -DG Health and Food Safety

8-3-2019

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to ACMS/ACCS meetings held in November 2018

Therapeutic Goods Administration - Australia

6-3-2019

L-Thyroxin Henning® 25 - 200

Rote - Liste

6-3-2019

Aponal® 5/Aponal® 10/Aponal® 25

Rote - Liste

4-3-2019

Agomelatin Anpharm 25 mg

Rote - Liste

27-2-2019

Agomelatin Mylan 25 mg Filmtabletten

Rote - Liste

25-2-2019

Vabomere (Menarini International Operations Luxembourg S.A.)

Vabomere (Menarini International Operations Luxembourg S.A.)

Vabomere (Active substance: meropenem/vaborbactam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1591 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004669/T/0001

Europe -DG Health and Food Safety

25-2-2019

Zulvac BTV (Zoetis Belgium S.A.)

Zulvac BTV (Zoetis Belgium S.A.)

Zulvac BTV (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1 strain out of a set of 3)) - Centralised - Variation - Commission Decision (2019)1607 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4185/X/01

Europe -DG Health and Food Safety

25-2-2019

EU/3/17/1880 (Chemocentryx Ireland Limited)

EU/3/17/1880 (Chemocentryx Ireland Limited)

EU/3/17/1880 (Active substance: Avacopan) - Transfer of orphan designation - Commission Decision (2019)1618 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004221

Europe -DG Health and Food Safety

25-2-2019

EU/3/10/732 (Southwood Research Limited)

EU/3/10/732 (Southwood Research Limited)

EU/3/10/732 (Active substance: Entinostat) - Transfer of orphan designation - Commission Decision (2019)1631 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004131

Europe -DG Health and Food Safety

25-2-2019

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Active substance: Chimeric monoclonal antibody to shiga-toxin 1 and 2) - Transfer of orphan designation - Commission Decision (2019)1636 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003835

Europe -DG Health and Food Safety

25-2-2019

EU/3/05/288 (Teva  GmbH)

EU/3/05/288 (Teva GmbH)

EU/3/05/288 (Active substance: 4-[3-(methylsulfonyl)phenyl]-1-propylpiperidine x HCl) - Transfer of orphan designation - Commission Decision (2019)1635 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003804

Europe -DG Health and Food Safety

25-2-2019

EU/3/16/1674 (Bellicum Pharma GmbH)

EU/3/16/1674 (Bellicum Pharma GmbH)

EU/3/16/1674 (Active substance: Allogeneic donor-derived ex-vivo expanded T lymphocytes transduced with a retroviral vector containing inducible caspase 9 and truncated CD19) - Transfer of orphan designation - Commission Decision (2019)1630 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004083

Europe -DG Health and Food Safety

25-2-2019

EU/3/16/1666 (Bellicum Pharma GmbH)

EU/3/16/1666 (Bellicum Pharma GmbH)

EU/3/16/1666 (Active substance: Rimiducid) - Transfer of orphan designation - Commission Decision (2019)1629 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004057

Europe -DG Health and Food Safety

25-2-2019

EU/3/15/1526 (Ultragenyx Netherlands B.V.)

EU/3/15/1526 (Ultragenyx Netherlands B.V.)

EU/3/15/1526 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2019)1632 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003558

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2019)1626 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003556

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2019)1634 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003636

Europe -DG Health and Food Safety

25-2-2019

EU/3/18/2026 (Alnylam Netherlands B.V.)

EU/3/18/2026 (Alnylam Netherlands B.V.)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)1637 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/O...

Europe -DG Health and Food Safety

25-2-2019

EU/3/15/1518 (Novartis Europharm Limited)

EU/3/15/1518 (Novartis Europharm Limited)

EU/3/15/1518 (Active substance: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1628 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003549

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Active substance: Adenovirus associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1627 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003485

Europe -DG Health and Food Safety

25-2-2019

EU/3/16/1637 (Alnylam Netherlands B.V.)

EU/3/16/1637 (Alnylam Netherlands B.V.)

EU/3/16/1637 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)1633 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003680

Europe -DG Health and Food Safety

25-2-2019

BLUEVAC BTV8 (CZ Veterinaria, S.A.)

BLUEVAC BTV8 (CZ Veterinaria, S.A.)

BLUEVAC BTV8 (Active substance: Bluetongue virus inactivated, serotype 8) - Centralised - Yearly update - Commission Decision (2019)1610 of Mon, 25 Feb 2019

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1259 (Insmed Netherlands B.V.)

EU/3/14/1259 (Insmed Netherlands B.V.)

EU/3/14/1259 (Active substance: Amikacin sulfate) - Transfer of orphan designation - Commission Decision (2019)1625 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003885

Europe -DG Health and Food Safety

25-2-2019

EU/3/06/387 (Insmed Netherlands B.V.)

EU/3/06/387 (Insmed Netherlands B.V.)

EU/3/06/387 (Active substance: Amikacin sulfate (liposomal)) - Transfer of orphan designation - Commission Decision (2019)1624 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003770

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1373 (Chemocentryx Ireland Limited)

EU/3/14/1373 (Chemocentryx Ireland Limited)

EU/3/14/1373 (Active substance: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide) - Transfer of orphan designation - Commission Decision (2019)1619 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004220

Europe -DG Health and Food Safety

25-2-2019

EU/3/14/1372 (Chemocentryx Ireland Limited)

EU/3/14/1372 (Chemocentryx Ireland Limited)

EU/3/14/1372 (Active substance: (2R,3S)-2-(4-cyclopentylaminophenyl)-1-(2-fluoro-6-methylbenzoyl)piperidine-3-carboxylic acid(4-methyl-3-trifluoromethylphenyl)amide) - Transfer of orphan designation - Commission Decision (2019)1620 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004218

Europe -DG Health and Food Safety

22-2-2019


Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Orphan designation: Becatecarin, Treatment of cancers of the biliary tree, 25/07/2006, Withdrawn

Europe - EMA - European Medicines Agency

18-2-2019

Imatinib Accord (Accord Healthcare S.L.U.)

Imatinib Accord (Accord Healthcare S.L.U.)

Imatinib Accord (Active substance: Imatinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1434 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2681/T/25

Europe -DG Health and Food Safety

15-2-2019

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here:  https://go.usa.gov/xEUeu  #Medi

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu  #Medi

Today, the @US_FDA announced an upcoming General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting that will take place on March 25-26. Learn more about the details and how to attend here: https://go.usa.gov/xEUeu  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

13-2-2019

Zinkorot® 25 Tabletten

Rote - Liste

5-2-2019

Juluca 50 mg/25 mg Filmtabletten

Rote - Liste

25-1-2019

Infanrix hexa (GlaxoSmithKline Biologicals S.A.)

Infanrix hexa (GlaxoSmithKline Biologicals S.A.)

Infanrix hexa (Active substance: diphtheria (d), tetanus (t), pertussis (acellular, component) (pa), hepatitis b (rdna) (hbv), poliomyelitis (inactivated) (ipv) and haemophilus influenzae type b (hib) conjugate vaccine (adsorbed)) - Centralised - Yearly update - Commission Decision (2019)676 of Fri, 25 Jan 2019

Europe -DG Health and Food Safety

25-1-2019

Luxturna (Novartis Europharm Limited)

Luxturna (Novartis Europharm Limited)

Luxturna (Active substance: voretigene neparvovec) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)675 of Fri, 25 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4451/T/01

Europe -DG Health and Food Safety

25-1-2019

Juluca (ViiV Healthcare BV)

Juluca (ViiV Healthcare BV)

Juluca (Active substance: dolutegravir / rilpivirine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)679 of Fri, 25 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4427/T/07

Europe -DG Health and Food Safety

25-1-2019

Dacogen (Janssen-Cilag International NV)

Dacogen (Janssen-Cilag International NV)

Dacogen (Active substance: Decitabine) - Centralised - 2-Monthly update - Commission Decision (2019)678 of Fri, 25 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002221/II/0033

Europe -DG Health and Food Safety

25-1-2019

Axumin (Blue Earth Diagnostics Ltd)

Axumin (Blue Earth Diagnostics Ltd)

Axumin (Active substance: fluciclovine (18F)) - Centralised - Yearly update - Commission Decision (2019)677 of Fri, 25 Jan 2019

Europe -DG Health and Food Safety

25-1-2019

Zoely (Teva B.V.)

Zoely (Teva B.V.)

Zoely (Active substance: nomegestrol / estradiol) - Centralised - Yearly update - Commission Decision (2019)684 of Fri, 25 Jan 2019

Europe -DG Health and Food Safety

25-1-2019

Biopoin (Teva  GmbH)

Biopoin (Teva GmbH)

Biopoin (Active substance: epoetin theta) - Centralised - Yearly update - Commission Decision (2019)682 of Fri, 25 Jan 2019

Europe -DG Health and Food Safety