FrancophonIA/ELRC3.0 huggingface dataset:
English: There was no need for ‘bioequivalence' studies to investigate whether Tigecycline Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Danish: Der var ikke behov for "bioækvivalente" undersøgelser af, om Tigecycline Accord absorberes på samme måde som referencelægemidlet for at producere samme niveau af det aktive stof i blodet.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Tigecycline Accord.
Danish: Virksomheden har oplyst CHMP om, at beslutningen ikke vil få konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser med Tigecycline Accord.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Tigecycline Accord could not have been approved to treat complicated infections.
Danish: På baggrund af gennemgangen af de oplysninger, der forelå på tidspunktet for tilbagetrækningen, havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Tigecycline Accord ikke kunne være blevet godkendt til behandling af komplicerede infektioner.
English: It was also intended to treat complicated infections in the abdomen (belly).
Danish: Det skulle også anvendes til komplicerede infektioner i bughulen (maven).
English: This is because Tigecycline Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Danish: Dette skyldes, at Tigecycline Accord gives ved infusion i en blodåre, så det aktive stof ledes direkte ind i blodbanen.
English: Tigecycline Accord is an antibiotic medicine that contains the active substance tigecycline.
Danish: Tigecycline Accord er et antibiotisk lægemiddel, der indeholder det aktive stof tigecyclin.
English: The active substance in Tigecycline Accord and Tygacil, tigecycline, is one of a group of antibiotics called ‘glycylcyclines'.
Danish: Det aktive stof i Tigecycline Accord og Tygacil, tigecyclin, tilhører en gruppe antibiotika, der kaldes glycylcykliner.
English: What was Tigecycline Accord expected to be used for?
Danish: Hvad forventedes Tigecycline Accord anvendt til?
English: What is Tigecycline Accord?
Danish: Hvad er Tigecycline Accord?
English: This means that Tigecycline Accord contains the same active substance and was intended to work in the same way as a ‘reference medicine' already authorised in the European Union called Tygacil.
Danish: Det betyder, at Tigecycline Accord er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Tygacil.
English: It was to be available as a powder to make a solution for infusion (drip) into a vein.
Danish: Det skulle markedsføres som et pulver, der blandes til en opløsning til infusion (drop) i en blodåre.
English: It works against the bacteria that cause infections by blocking the bacteria's ribosomes, the parts of the cell where new proteins are made.
Danish: Det virker ved at blokere de infektionsskabende bakteriers ribosomer, dvs. de dele af
English: How does Tigecycline Accord work?
Danish: Hvordan virker Tigecycline Accord?
English: Creatinine clearance (CLcr) (mL/min)
Danish: Kreatininclearance (CLcr) (ml/min)
English: If you are an elderly patient (over 65 years of age), you should take Pregabalin Sandoz GmbH normally except if you have problems with your kidneys.
Danish: Hvis De er ældre (over 65 år), skal De tage Pregabalin Sandoz GmbH som normalt, medmindre De har nyreproblemer.
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16
Danish: Farmakoterapeutisk klassifikation: Antiepileptika, andre antiepileptika ATC-kode: N03AX16
English: Pregabalin Sandoz GmbH should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Danish: Pregabalin Sandoz GmbH bør ikke anvendes under graviditet, medmindre det er klart nødvendigt (hvis fordelene for moderen klart opvejer den mulige risiko for fosteret/det nyfødte barn).
English: If you have the impression that the effect of Pregabalin Sandoz GmbH is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis De har indtryk af, at virkningen af Pregabalin Sandoz GmbH er for stærk eller alt for svag, skal De tale med Deres læge eller apotekspersonalet.
English: • A small number of people being treated with anti-epileptics such as Pregabalin Sandoz GmbH have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin som for eksempel Pregabalin Sandoz GmbH, har haft selvmordstanker eller tanker om at gøre skade på sig selv.
English: Do not take Pregabalin Sandoz GmbH: If you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Pregabalin Sandoz GmbH: Hvis De er allergisk over for pregabalin eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: These symptoms may occur more commonly or severely if you have been taking Pregabalin Sandoz GmbH for a longer period of time.
Danish: Disse symptomer kan forekomme oftere eller i en alvorligere grad, hvis De har taget Pregabalin Sandoz GmbH i længere tid.
English: If you experience swollen face or tongue or if your skin turns red and starts to blister or peel, you should seek immediate medical advice.
Danish: Hvis Deres ansigt eller tunge hæver eller, hvis huden bliver rød og begynder at danne blærer eller skalle af, skal De straks kontakte læge eller skadestue.
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Sandoz GmbH is taken together with medicines containing:
Danish: Graden af svimmelhed, søvnighed og nedsat koncentrationsevne kan øges, når Pregabalin Sandoz GmbH tages sammen med lægemidler, der indeholder:
English: Pregabalin Sandoz GmbH is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Danish: Pregabalin Sandoz GmbH er ikke beregnet til at blive brugt alene, men skal altid anvendes i kombination med anden behandling mod epilepsi.
English: Cases of misuse, abuse and dependece have been reported.
Danish: Tilfælde af forkert brug, misbrug og afhængighed er blevet rapporteret.
English: Pregabalin Sandoz GmbH and certain other medicines may influence each other (interaction).
Danish: Pregabalin Sandoz GmbH og anden medicin kan påvirke hinanden (interaktion).
English: Бул.“Никола Вапцаров“ No. 55 сгр.
Danish: Бизнес Парк София, Младост 4, Бул.“Никола Вапцаров“ No. 55 сгр.
English: Your doctor will prescribe Pregabalin Sandoz GmbH for you to help treat your epilepsy when your current treatment is not controlling your condition.
Danish: Deres læge vil udskrive Pregabalin Sandoz GmbH til behandling af Deres epilepsi, hvis Deres nuværende behandling ikke kan kontrollere Deres tilstand.
English: Pregabalin Sandoz GmbH 25 mg hard capsules Pregabalin Sandoz GmbH 50 mg hard capsules Pregabalin Sandoz GmbH 75 mg hard capsules Pregabalin Sandoz GmbH 100 mg hard capsules Pregabalin Sandoz GmbH 150 mg hard capsules Pregabalin Sandoz GmbH 200 mg hard capsules Pregabalin Sandoz GmbH 225 mg hard capsules Pregabalin Sandoz GmbH 300 mg hard capsules Pregabalin
Danish: Pregabalin Sandoz GmbH 25 mg hårde kapsler Pregabalin Sandoz GmbH 50 mg hårde kapsler Pregabalin Sandoz GmbH 75 mg hårde kapsler Pregabalin Sandoz GmbH 100 mg hårde kapsler Pregabalin Sandoz GmbH 150 mg hårde kapsler Pregabalin Sandoz GmbH 200 mg hårde kapsler Pregabalin Sandoz GmbH 225 mg hårde kapsler Pregabalin Sandoz GmbH 300 mg hårde kapsler Pregabalin
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Danish: Indberetning af mistænkte bivirkninger Når lægemidlet er godkendt, er indberetning af mistænkte bivirkninger vigtig.
English: - The other ingredients are pregelatinised maize starch, maize starch, talc, gelatin, titanium dioxide (E171), yellow iron oxide (E172) (all strengths except 150 mg), red iron oxide (E172) (all strengths except 50 mg and 150 mg), black iron oxide (E172) (only 25 mg and 300 mg).
Danish: - Øvrige indholdsstoffer: pregelatineret majsstivelse, majsstivelse, talcum, gelatine, titandioxid (E171), gul jernoxid (E172) (alle styrker undtagen 150 mg), rød jernoxid (E172) (alle styrker undtagen 50 mg og 150 mg), sort jernoxid (E172) (kun 25 mg og 300 mg).
English: This may be attributed to an additive effect due to concomitant medicinal products (e.g. anti-spasticity agents) needed for this condition.
Danish: Dette kan måske tilskrives en additiv effekt på grund af samtidig medicin (f.eks. antispastisk medicin), som er nødvendig for behandling af denne tilstand.
English: • Your doctor will tell you to take Pregabalin Sandoz GmbH either twice or three times a day.
Danish: Deres læge vil fortælle, at De enten skal tage Pregabalin Sandoz GmbH 2 gange eller 3 gange dagligt.
English: A meta-analysis of randomised placebo controlled studies of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.
Danish: En metaanalyse af randomiserede, placebokontrollerede forsøg med antiepileptika har også vist en let forøget risiko for selvmordstanker og -adfærd.
English: For three times a day take Pregabalin Sandoz GmbH once in the morning, once in the afternoon and once in the evening, at about the same time each day.
Danish: For 3 gange dagligt skal Pregabalin Sandoz GmbH tages én gang om morgenen, én gang om eftermiddagen og én gang om aftenen og på omtrent samme tid hver dag.
English: Pregabalin Sandoz GmbH is available in the following presentations: PVC/PVDC//Alu blisters packed in carton.
Danish: Pregabalin Sandoz GmbH findes i de følgende præsentationer: PVC/PVDC//Alu-blistere pakket i æske.
English: It is advised not to drink alcohol while taking Pregabalin Sandoz GmbH.
Danish: Det tilrådes ikke at drikke alkohol, når De tager Pregabalin Sandoz GmbH.
English: You may feel sleepy, confused, agitated, or restless as a result of taking more Pregabalin Sandoz GmbH than you should.
Danish: De kan føle Dem søvnig, forvirret, oprevet eller rastløs, hvis De har taget for meget Pregabalin Sandoz GmbH.
English: Pregabalin Sandoz GmbH with food, drink and alcohol Pregabalin Sandoz GmbH capsules may be taken with or without food.
Danish: Brug af Pregabalin Sandoz GmbH sammen med mad, drikke og alkohol Pregabalin Sandoz GmbH kapsler kan tages både sammen med og uden mad.
English: Continue taking Pregabalin Sandoz GmbH until your doctor tells you to stop.
Danish: Fortsæt med at tage Pregabalin Sandoz GmbH, indtil Deres læge beder Dem om at stoppe.
English: In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: De er anført efter organklasse og hyppighed (meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjældne (< 1/10.000)), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Pregabalin Sandoz GmbH may be taken with or without food.
Danish: Pregabalin Sandoz GmbH kan tages med eller uden mad.
English: • Pregabalin Sandoz GmbH may cause blurring or loss of vision, or other changes in eyesight, many of which are temporary.
Danish: • Pregabalin Sandoz GmbH kan forårsage sløret syn, synstab eller andre synsændringer, som kan være forbigående.
English: When taken with certain other medicines, Pregabalin Sandoz GmbH may potentiate the side effects seen with these medicines, including respiratory failure and coma.
Danish: Når det bruges sammen med visse typer medicin, kan Pregabalin Sandoz GmbH forstærke de bivirkninger, der er set med denne type medicin, herunder åndedrætssvigt og dyb bevidstløshed.
English: Epilepsy: Pregabalin Sandoz GmbH is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Danish: Epilepsi: Pregabalin Sandoz GmbH anvendes til behandling af visse former for epilepsi (partielle anfald med eller uden sekundær generalisering) hos voksne.
English: You should take Pregabalin Sandoz GmbH in addition to your current treatment.
Danish: De skal tage Pregabalin Sandoz GmbH sammen med Deres nuværende behandling.
English: For twice a day take Pregabalin Sandoz GmbH once in the morning and once in the evening, at about the same time each day.
Danish: For 2 gange dagligt skal Pregabalin Sandoz GmbH tages én gang om morgenen og én gang om aftenen og på omtrent samme tid hver dag.
English: What Pregabalin Sandoz GmbH contains - The active substance is pregabalin.
Danish: Pregabalin Sandoz GmbH indeholder: - Aktivt stof: pregabalin.
English: • When Pregabalin Sandoz GmbH is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel).
Danish: • Når Pregabalin Sandoz GmbH tages med andre lægemidler, som er kendt for at kunne give forstoppelse (som f.eks. visse typer smertestillende medicin), kan det give maveproblemer (f.eks. forstoppelse, tarmslyng).
English: After stopping long and short-term Pregabalin Sandoz GmbH treatment, you need to know that you may experience certain side effects.
Danish: Når De stopper med at tage Pregabalin Sandoz GmbH efter langtidsbehandling eller korttidsbehandling, skal De vide, at De måske får visse bivirkninger.
English: Other medicines and Pregabalin Sandoz GmbH Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Pregabalin Sandoz GmbH Fortæl det altid til lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: Pregabalin Sandoz GmbH may produce dizziness, sleepiness and decreased concentration.
Danish: Pregabalin Sandoz GmbH kan give svimmelhed, søvnighed og nedsat koncentrationsevne.
English: 6.5 Nature and contents of container PVC/PVDC//Alu blister.
Danish: 6.5 Emballagetype og pakningsstørrelser PVC/PVDC//Alu blister.
English: Pregabalin Sandoz GmbH should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor.
Danish: Pregabalin Sandoz GmbH bør ikke tages under graviditet, eller hvis De ammer, medmindre Deres læge har givet Dem en anden besked.
English: Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Danish: Pregabalin Sandoz GmbH er indiceret som supplerende behandling til voksne med refraktære partielle anfald med eller uden sekundær generalisering.
English: - If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: Pregabalin Sandoz GmbH is for oral use only.
Danish: Pregabalin Sandoz GmbH er kun til oral anvendelse.
English: CY-000 00 Πόλη: Λεμεσός Τηλ: 00357 25372425 hapanicos@cytanet.com.cy
Danish: Τηλ: 00357 25372425 hapanicos@cytanet.com.cy
English: BID = Two divided doses * Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose + Supplementary dose is a single additional dose
Danish: * Total døgndosis (mg/døgn) skal fordeles som anført under dosisinterval for at give mg/dosis
English: These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication.
Danish: kompromiterede patienter, der er i behandling med pregabalin for en neuropatisk indikation.
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3(aminomethyl)-5-methylhexanoic acid].
Danish: Det aktive indholdsstof, pregabalin, er en gamma-aminosmørsyre-analog [(S)-3-(aminomethyl)-5-methylhexansyre].
English: Österreich Sandoz GmbH Biochemiestr.
Danish: Sandoz GmbH Biochemiestr.
English: It is important to take your Pregabalin Sandoz GmbH capsules regularly at the same time each day.
Danish: Hvis De har glemt at tage Pregabalin Sandoz GmbH Det er vigtigt, at De tager Deres Pregabalin Sandoz GmbH kapsler regelmæssigt og på samme tid hver dag.
English: MARKETING AUTHORISATION HOLDER Sandoz GmbH
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Sandoz GmbH
English: Pregabalin Sandoz GmbH belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults.
Danish: Pregabalin Sandoz GmbH tilhører den gruppe medicin, der anvendes til behandling af epilepsi og generaliseret angst hos voksne.
English: Marketing Authorisation Holder Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Danish: Indehaver af markedsføringstilladelsen Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Østrig
English: Rīga, LV1010 Tel: + 371 67892006
Danish: Tel: + 371 67892006
English: Camberley, GU16 7SR, UK Tel: + 44 1276 698020 uk.regaffairs@sandoz.com
Danish: United Kingdom Sandoz Limited Frimley Business Park Camberley, GU16 7SR, UK Tel: + 44 1276 698020 uk.regaffairs@sandoz.com
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige: Kan optræde hos flere end 1 ud af 10 behandlede
English: SK-811 02 Bratislava Tel: + 421 2 48 200 600
Danish: SK-811 02 Bratislava Tel: + 421 2 48 200 600 info@sandoz.sk
English: Pregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Danish: Generaliseret angst Pregabalin Sandoz GmbH er indiceret til behandling af generaliseret angst (GAD) hos voksne.
English: An increased incidence of retinal atrophy commonly observed in aged albino rats was seen after long-term exposure to pregabalin at exposures≥ 5 times the mean human exposure at the maximum recommended clinical dose.
Danish: En øget hyppighed af nethindeatrofi ses sædvanligvis hos ældre albinorotter efter langtidseksponering med pregabalin ved doser ≥ 5 gange den maksimale anbefalede gennemsnitlige humane dosis.
English: Talk to your doctor or pharmacist before taking Pregabalin Sandoz GmbH.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før De tager Pregabalin Sandoz GmbH.
English: Generalised Anxiety Disorder: Pregabalin Sandoz GmbH is used to treat Generalised Anxiety Disorder (GAD).
Danish: Generaliseret angst: Pregabalin Sandoz GmbH anvendes til generaliseret angst.
English: Pregabalin Sandoz GmbH may cause dizziness and somnolence and therefore may influence the ability to drive or use machines.
Danish: Pregabalin Sandoz GmbH kan påvirke evnen til at føre motorkøretøj og betjene maskiner i mindre eller moderat grad. Pregabalin Sandoz GmbH kan forårsage svimmelhed og søvnighed, og derfor kan det påvirke evnen til at køre bil eller betjene maskiner.
English: Hepatobiliary disorders
Danish: Seponeringssymptomer
English: Do not stop taking Pregabalin Sandoz GmbH unless your doctor tells you to.
Danish: Hvis De holder op med at tage Pregabalin Sandoz GmbH De må ikke stoppe med at tage Pregabalin Sandoz GmbH, medmindre Deres læge har bedt Dem herom.
English: Take your box or bottle of Pregabalin Sandoz GmbH capsules with you.
Danish: Medbring pakningen med Pregabalin Sandoz GmbH kapsler.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/057-062 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 June 2015
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/057-062 DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 19. juni 2015 10.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/042-056 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 June 2015
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/042-056 DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 19. juni 2015 10.
English: Pregabalin Sandoz GmbH may be taken with oral contraceptives.
Danish: Pregabalin Sandoz GmbH kan tages sammen med svangerskabsforebyggende medicin.
English: If you take more Pregabalin Sandoz GmbH than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Danish: Hvis De har taget for meget Pregabalin Sandoz GmbH Kontakt omgående lægen eller skadestuen.
English: Rare: may affect up to 1 in 1,0000 people
Danish: Sjældne: Kan optræde hos op til 1 ud af 1.000 behandlede
English: Blisters containing 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules.
Danish: Blisterpakninger: 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) eller 120 (2 x 60) hårde kapsler.
English: What you need to know before you take Pregabalin Sandoz GmbH
Danish: Det skal De vide, før De begynder at tage Pregabalin Sandoz GmbH
English: The incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased in the treatment of central neuropathic pain due to spinal cord injury (see section 4.4).
Danish: Ved behandling af centrale neuropatiske smerter grundet rygmarvsskader, er der generelt set en øget forekomst af bivirkninger, som bivirkninger i centralnervesystemet og især søvnighed (se pkt.
English: Adverse reactions in patients with spinal cord injury The incidence of adverse reactions in general, central nervous system adverse reactions and especially somnolence was increased in the treatment of central neuropathic pain due to spinal cord injury.
Danish: Ved behandling af centrale neuropatiske smerter grundet rygmarvsskader, er der generelt set en øget forekomst af bivirkninger, som bivirkninger i centralnervesystemet og især søvnighed.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/011-017
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/011-017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/074-076
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/074-076
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/001-010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/001-010
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 150 mg
Danish: INFORMATION I BRAILLESKRIFT Pregabalin Sandoz GmbH 150 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/018-029
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/018-029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/031-033
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/031-033
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/054-056
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/054-056
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/081-083
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/081-083
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/057-062
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/057-062
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/042-052
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/042-052
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/063-068
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/063-068
English: Blister packs (unit dose): 56 x 1, 84 x 1 or 100 x 1 hard capsules.
Danish: Blisterpakninger (enkeltdosis): 84 x 1 eller 100 x 1 hårde kapsler.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/084
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/084
English: : + 359 2 970 47 47 regaffairs.bg@sandoz.com
Danish: 1407 София regaffairs.bg@sandoz.com
English: INFORMATION IN BRAILLE Pregabalin Sandoz GmbH 225 mg
Danish: Pregabalin Sandoz GmbH 225 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/085
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/085
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/034-041
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/034-041
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1012/069-073
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1012/069-073